CHAMGAP

F-ACP dental mousse · White spots after orthodontic treatment · Six-month ICDAS remineralization evidence sheet

Select a review item to see its details.
Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Evidence conditionWhich existing question and record are being presented in the sheet?Required
The selected question is 'ICDAS remineralization of white spots'; the question and existing verdict record are distinguished. The parent concerns lesion remineralization after orthodontic treatment, while the sibling concerns a different outcome, prevention of incident caries.
Some information from the stored summary was linked for production. The original candidate-boundary review wait is historical information; no model content/boundary review was performed in this work. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Relationships among the original question, record and parent/sibling outcomes
If additional material is provided, a linked outcome text retaining the original existing question and its connection
2 Partly verified Full text not readStored summary read N02 · Evidence conditionHow are the subclaim C/note, parent C50 and missing scores/axes distinguished?Required
The original subclaim grade C and note 'Score improvement was confirmed' are retained. Subclaim scores/status/axes are absent; the parent C50, Good status and axes are parent history.
Some information from the stored summary was linked for production. There are no direct values for the selected subclaim score, status or axes. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
A separate record of original subclaim/parent verdicts, notes, scores/axes and missing values
If an actual verdict correction is provided, separate the complete original text, event/version and change decision
3 Partly verified Full text not readStored summary read N03 · Evidence conditionWhat is shared among one report, lesions/patients and sibling questions?Required
Ciribè et al. 2024, PMID38927409, occupies 1 slot in each evidence/citation list. The same trial's patients, lesions/teeth, baseline/six months, safety and unmeasured caries-prevention context are linked.
Some information from the stored summary was linked for production. Follow-up/other report versions, overlapping populations, lesion/tooth relationships and current unique trial/participant totals are unresolved. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Relationship table for bibliography/trial families, patients/teeth/lesions and times/outcomes
If additional reports are provided, distinguish relationships among the same populations/reports/outcomes and separate material
4 Partly verified Full text not readStored summary read N04 · Evidence conditionWhat are the actual summary-reading and external original-material statuses?Required
The complete specified stored summary was read for production and the original was preserved. The original PubMed URL is only linked; external abstracts, full texts, registrations and plans are unread.
Some information from the stored summary was linked for production. External public availability/acquisition, current content, access success and link operation were not verified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Stored summaries and external original-material existence/acquisition, reading level and original locations
When further acquisition is allowed, record actual reading/attempts and dates separately
5 Partly verified Full text not readStored summary read N05 · Evidence conditionWhat is the scope of white spots after orthodontic treatment and the actual population?Required
The original question concerns white spots after orthodontic treatment, and the existing English research description says 'randomized adolescents'. Each Korean/English population wording is preserved as recorded.
Some information from the stored summary was linked for production. Age range, sex, baseline lesion/caries risk, orthodontic/retainer status, eligibility/exclusions and recruitment are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original population eligibility/exclusions, baseline risk, age and orthodontic-status table
Same-trial material specifying the selected population and direct outcomes, or appropriate separate material
6 Unverified Full text not readStored summary read N06 · Evidence conditionWhat are the baseline lesion/tooth distribution and assessment conditions?Required
The original material presents patient counts and arm-specific baseline/six-month ICDAS values, but no separate lesion location, tooth/patient distribution or assessment environment.
The required direct details were not verified within the current stored-summary and unread-external-material scope. Teeth/surfaces, lesion counts, lesion criteria, photography/drying, orthodontic completion timing, assessment environment and baseline balance are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original lesion/tooth distribution, selection criteria and assessment-environment/baseline table
Original material linking patient/lesion baseline status to measurement conditions
7 Partly verified Full text not readStored summary read N07 · Evidence conditionWhat are the original F-ACP ingredients and the other CPP-ACP product families?Required
The existing product information states that F-ACP is an amorphous calcium phosphate complex containing fluoride and carbonate. Marketing of fluoride/CPP-ACP product families in the existing advertising interpretation is a different-product-family context.
Some information from the stored summary was linked for production. The finished trial product/manufacturer, ingredient concentrations, other additives, batches, provision/quality and equivalence between products are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Trial-product identity, composition/concentration and original product/provision information
Material specifying applicability differences between the actual trial product and other compositions/products
8 Partly verified Full text not readStored summary read N08 · Evidence conditionWhat is the scope of six-month research exposure inside an Essix retainer?Required
The original research condition involved applying mousse inside an Essix retainer for six months. The combined product, retainer and duration exposure is recorded as originally stated.
Some information from the stored summary was linked for production. Application amount, frequency, retainer wear/cleaning, actual adherence, discontinuations/changes, contact time and route details are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original product/retainer exposure, nominal/actual use and adherence/change material
Original implementation material linking actual exposure and outcomes in the same study
9 Unverified Full text not readStored summary read N09 · Evidence conditionWere the control arm's fluoride and basic treatment conditions directly reported?Required
The existing verdict rationale records control-arm ICDAS values, but the specified summary contains no control product/fluoride ingredients, concentrations or exposure. F-ACP's fluoride ingredients and product-family marketing are not control treatment.
The required direct details were not verified within the current stored-summary and unread-external-material scope. Direct definitions of control-arm fluoride/toothpaste, retainers, placebo/no treatment, hygiene/diet and common/arm-specific care are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original control treatment, product/concentration, common/arm-specific care and actual implementation
Protocol/report specifying the actual control and concurrent conditions in the same trial
10 Partly verified Full text not readStored summary read N10 · Evidence conditionWhat are the denominators for 106 randomized, 91 completers and 52/39 participants?Required
The original n is 106 randomized and 91 completers analyzed; the existing Korean research description records 52 mousse and 39 control participants. Each number is an original patient-denominator record.
Some information from the stored summary was linked for production. Randomized n by arm, selection/exposure/completion/assessment flow, tooth/lesion counts and original counts by exclusion reason are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Allocation → exposure → completion/assessment → analysis, and patient/lesion denominator tables
Same-trial material linking arm-specific flow to original denominators for each unit
11 Partly verified Full text not readStored summary read N11 · Evidence conditionWhat is the scope of the original 14.2% dropout and completer selection?Required
The original records 91/106, 14.2% dropout and completer analysis. Dropout rates, analysis inclusion and original observation/exposure are distinguished.
Some information from the stored summary was linked for production. Arm-specific dropout/nonadherence, timing/reasons, dropout baseline/outcomes, missing-data handling and sensitivity are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original dropout/exclusion, follow-up, baseline/missing-data handling and analysis flow
Same-trial material specifying completer/noncompleter data and original analysis assumptions
12 Partly verified Full text not readStored summary read N12 · Evidence conditionWhat are the original randomization, concealment and design details?Required
The evidence-list design is a randomized controlled trial. Actual allocation, concealment and baseline-balance details require material separately from the original subclaim/parent verdicts.
Some information from the stored summary was linked for production. The summary lacks parallel/cluster/crossover design, random-sequence/allocation concealment, baseline balance and implementation-role details. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original allocation/design, concealment, baseline tables and implementation material
Material specifying the actual comparative design in the protocol/report
13 Partly verified Full text not readStored summary read N13 · Evidence conditionWhat are the ICDAS assessment, masking and measurement reliability?Required
The original endpoint is the six-month ICDAS white-spot score. The original indicates greater lesion severity with higher scores, but assessors/masking and examination conditions are separate matters.
Some information from the stored summary was linked for production. ICDAS version, assessors/calibration, masking, photographs/examinations, inter-assessment agreement, missing assessments and arm differences are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original ICDAS criteria, assessors/masking, measurement conditions and reliability material
Original methods/appendices linking actual readings, measurement limitations and results
14 Unverified Full text not readStored summary read N14 · Evidence conditionAre patient, tooth and lesion units distinguished from repeated measurements?Required
The original explanation identifies n as people and ICDAS as lesion scores. Multiple teeth/lesions and baseline/six-month values from the same person are not counted as independent participants.
The required direct details were not verified within the current stored-summary and unread-external-material scope. ICDAS aggregation units, lesions per patient, selected teeth/surfaces, cluster/repeated-measure handling and denominators are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Patient–tooth–lesion relationships, aggregation/models and unit-specific denominator/measurement tables
Material specifying original measurement units and within-patient correlation/repeated measurements
15 Partly verified Full text not readStored summary read N15 · Evidence conditionWhat are six-month ICDAS, nominal exposure and assessment timing?Required
The original records six-month ICDAS and six-month retainer/mousse exposure. Individual actual use duration, assessment windows and intermediate measurements are separate matters.
Some information from the stored summary was linked for production. Orthodontic completion/baseline, final assessment timing, allowed windows, intermediate times, data cutoff and actual exposure/safety follow-up are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original schedules, baseline/six months, actual exposure/assessment and missing-data material
Same-trial material linking assessment windows/exposure and time-specific outcomes
16 Partly verified Full text not readStored summary read N16 · Evidence conditionWhat is the original direction of baseline and six-month final values?Required
The existing Korean verdict rationale records mousse 1.80→1.00 points and control 1.92→1.53 points. The original explanation that higher is worse and reduction indicates improvement is retained.
Some information from the stored summary was linked for production. Details of each value's mean/median, dispersion/CI, aggregation/measurement unit, adjustment and original timing are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original baseline/final tables, aggregation/dispersion, units/denominators and models
The same report providing original final/baseline values, dispersion and outcome units
17 Partly verified Full text not readStored summary read N17 · Evidence conditionWhat do changes of 0.80 versus 0.39 points represent?Required
The original ICDAS reductions are 0.80 versus 0.39 points. Positively expressed reductions are recorded alongside the lower-is-better direction of final ICDAS values.
Some information from the stored summary was linked for production. Details of sign/aggregation, change dispersion, paired measurements/adjustment and within-arm versus between-arm tests are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original change definitions, sign/units, dispersion, analysis methods and tables
Material reporting changes/final values and distinguishing within-arm/between-arm results
18 Partly verified Full text not readStored summary read N18 · Evidence conditionWhat is the level of the original 0.41-point difference in change?Required
The existing Korean verdict rationale records a 0.41-point difference in change. This existing original value is preserved; its model, CI and importance remain separate matters.
Some information from the stored summary was linked for production. Adjustment, dispersion/CI, aggregation/clustering/repeated measurements and clinical-importance criteria are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original between-arm change differences, models/units and CI/criterion tables
Material reporting definitions/intervals and importance of original between-arm outcomes
19 Partly verified Full text not readStored summary read N19 · Evidence conditionWhat are between-arm P=0.003 and the effect interval?Required
The evidence list records between-arm P=0.003 and the existing English text records P=.003. These are retained alongside the original direction of ICDAS changes; P is distinguished from effect size/intervals.
Some information from the stored summary was linked for production. Original tests/models, CIs, dispersion, multiplicity, measurement/analysis units and importance are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original statistical methods, test targets, effects/CIs and unit material
Original result tables linking actual models/intervals and testing objectives
20 Unverified Full text not readStored summary read N20 · Evidence conditionWhat are score aggregation, models and within-arm/between-arm analyses?Required
The original records ICDAS baseline/final values, changes and between-arm P. The summary does not explain models for score means, categories/stages or patient/lesion aggregation.
The required direct details were not verified within the current stored-summary and unread-external-material scope. Scale treatment, aggregation, baseline adjustment, clustering/repeated measurements, analysis assumptions, sensitivity and change dispersion are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original score aggregation/statistical methods, SAP, models/units and tables
Material specifying original ICDAS analysis with units, models and assumptions
21 Partly verified Full text not readStored summary read N21 · Evidence conditionHow do completer effects differ from effects in the full randomized population?Required
The original main result is a 91/106 completer analysis; the parent verdict historically described this defect as avoidable through ITT/missing-data handling. Actual ITT results were not provided.
Some information from the stored summary was linked for production. Allocation/adherence effects, completion selection, arm-specific exclusions and original ITT/sensitivity outcomes are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original analysis populations, completion/exclusions, missing-data assumptions and alternative analyses
Material reporting randomized/completer populations and the actual scope of missing data
22 Unverified Full text not readStored summary read N22 · Evidence conditionWhat are the reported intervals and criteria for an important ICDAS difference?Required
Original changes/differences and P are retained. Although ICDAS is lower-is-better, the summary lacks justified important-difference/patient-utility criteria and CIs.
The required direct details were not verified within the current stored-summary and unread-external-material scope. Minimum important differences, stage/lesion-recovery criteria, intervals/dispersion and power/original plans are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original importance/clinical-linkage criteria, effect intervals and planning assumptions
If justified original criteria are provided, link them with score differences/intervals
23 Partly verified Full text not readStored summary read N23 · Evidence conditionWhat do registration 'Not confirmed', prespecification and plans mean?Required
The existing registration identifier record is the string 'Not confirmed'. The current registration ID remains null; this original record and unverified scope are retained.
Some information from the stored summary was linked for production. Registration/protocol/SAP, original primary/secondary outcomes, analyses/times and change history are externally unread. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original registration/plans, endpoints/times, analysis versions and change material
If actual plans are provided, distinguish original unverified status from new additional events/comparison scope
24 Unverified Full text not readStored summary read N24 · Evidence conditionWhat is the scope of multiplicity and disclosure of all outcomes/times?Required
The original material contains six-month ICDAS, adverse-effect reporting and unmeasured caries context. It does not provide a complete primary/secondary endpoint, time or analysis list.
The required direct details were not verified within the current stored-summary and unread-external-material scope. Full outcome lists, multiplicity adjustment, exploratory/confirmatory status, prespecified analyses/changes and unpublished outcomes are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Protocol/SAP, all outcomes/times and reporting/change tables
Material linking original plans and reports by outcome
25 Partly verified Full text not readStored summary read N25 · Evidence conditionWhat are the original verdict and unmeasured scope for sibling caries prevention?Required
The caries-prevention sheet concerns 'Prevention of incident caries', with grade '?' and the note 'Not measured'. The parent verdict states that reduced new caries/filling treatment was not measured.
Some information from the stored summary was linked for production. Original clinical-event definitions/collection, long-term outcomes, registration plans and current related material were not verified in this work. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
The same trial's outcome list and direct clinical-event material for the prevention question
If direct event material is provided, distinguish connections for remineralization from separate questions/scopes
26 Partly verified Full text not readStored summary read N26 · Evidence conditionDoes ICDAS remineralization also answer questions about new caries, fillings or tooth loss?Required
The selected outcome is a lesion-score surrogate. The existing core explanation/counterview states that improved scores cannot be transferred to reduced caries incidence or filling treatment.
Some information from the stored summary was linked for production. Direct clinical-event effects, units/denominators, duration, surrogate prediction/mediation and long-term material are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Direct definitions, denominators and durations for new caries/treatment and tooth outcomes, with related validation
If appropriate direct event material is provided, link scores and clinical outcomes separately
27 Unverified Full text not readStored summary read N27 · Evidence conditionAre visual improvement and benefits in patient appearance/daily life the same?Supplementary; required for extension to daily-life benefits
The existing counterview states that visual/score-based remineralization may be useful to patients. It does not provide direct patient satisfaction, appearance/pain or quality-of-life values.
The required direct details were not verified within the current stored-summary and unread-external-material scope. Patient-reported appearance/satisfaction, daily life/quality of life, symptoms, persistence, importance and denominators are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Patient-centered outcomes/scales, definitions, denominators/times and original results
If material directly reporting patient-centered outcomes is provided, distinguish it from lesion scores
28 Unverified Full text not readStored summary read N28 · Evidence conditionWhat are the concurrent or alternative effects of hygiene, fluoride, diet and retainers?Required
The original comparison concerns lesion-score changes with F-ACP mousse/Essix. The summary lacks actual balance in basic oral care, other products/diet and natural recovery.
The required direct details were not verified within the current stored-summary and unread-external-material scope. Arm-specific concurrent fluoride/toothpaste, diet/hygiene, retainers, natural course, intervention/assessment differences and handling methods are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Control/concurrent treatment, actual behavior/adherence and original baseline/analysis material
Material linking common/different exposures and the original effect of interest in the same randomized comparison
29 Partly verified Full text not readStored summary read N29 · Evidence conditionWhat are actual adherence, discontinuations and duration/dose comparisons?Required
Six-month mousse exposure inside Essix is a nominal research condition. Actual individual adherence, dose reduction/discontinuation and direct comparisons of other durations/products are not separately provided.
Some information from the stored summary was linked for production. Adherence measurement/distribution, discontinuations/changes, actual contact/amount and direct frequency/duration/formulation comparisons are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original adherence/changes, exposure and direct-comparison/SAP material
Material distinguishing direct exposure-specific outcomes in the same or appropriate additional research
30 Unverified Full text not readStored summary read N30 · Evidence conditionWhat direct material addresses other populations, subgroups and long-term maintenance?Supplementary; required for extension
The original is a six-month lesion-surrogate trial in post-orthodontic white spots. Other ages/lesion risks, during-orthodontic/non-orthodontic settings and persistence after stopping are separate questions.
The required direct details were not verified within the current stored-summary and unread-external-material scope. Prespecified subgroups/interactions, direct population/product comparisons, longer follow-up and persistence after stopping are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Extended populations/exposures, prespecified subgroups and duration-specific direct outcomes
If additional material is provided, specify differences from original populations, exposures and times in the connection
31 Partly verified Full text not readStored summary read N31 · Evidence conditionDo single-trial/R1/I1 history and current independent replication differ?Required
The parent records a small single trial and R1/I1 in the original verdict. The 1 evidence/citation slot, patients/teeth/lesions and two siblings are not current independent replications.
Some information from the stored summary was linked for production. Current additional/follow-up reports, direct replication in other populations/products and material-family/independence relationships were not newly searched. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Report/trial/population, product/source and outcome relationships, with direct independent material
If material is provided, list same/separate/unclear populations and distinguish verification levels
32 Partly verified Full text not readStored summary read N32 · Evidence conditionWhat history is represented by the original small-study/completer and duration defect descriptions?Required
The parent verdict records two listed defects: fewer than 200 participants and completer analysis. It explains that six months was not counted because it was not shorter than 12 weeks. This is parent-score/verdict history.
Some information from the stored summary was linked for production. These case-specific conditions did not automatically adopt the original 200 participants/12 weeks as minimum criteria or reassess them as new defect scores. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Complete parent-verdict history and actual design/analysis material
If corrections/method changes are provided, preserve original history separately from new events
33 Partly verified Full text not readStored summary read N33 · Evidence conditionWhat is the scope of no patient/guardian-reported adverse effects over six months?Required
The existing safety description states that patients or guardians reported no adverse effects over six months. The original parent Good safety status is preserved separately from this reporting scope.
Some information from the stored summary was linked for production. Event definitions, systematic/spontaneous collection, grades/discontinuations, original safety denominators and actual records/verification are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original adverse-effect reporting/collection, population/duration and definition/discontinuation material
Original material specifying reporting methods and the actual safety scope for the same exposure
34 Unverified Full text not readStored summary read N34 · Evidence conditionWhat are the adverse-effect denominators, dropout and reporting selection?Required
The original 91/106 completers and 52/39 participants form the efficacy-analysis population. The summary does not distinguish whether patient/guardian adverse-effect reporting covered all randomized participants, completers or those actually exposed.
The required direct details were not verified within the current stored-summary and unread-external-material scope. Safety populations, reporting/exposure/follow-up, events among dropouts, missing reports/recall and arm-specific detection differences are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original safety-population/exposure, collection/missing reports and dropout/follow-up tables
Safety material specifying denominators and reporting/follow-up selection
35 Unverified Full text not readStored summary read N35 · Evidence conditionWhat are harm occurrence, discontinuation and exposure/follow-up times?Required
The original safety-reporting window is six months. Actual mousse/retainer exposure, onset/recovery, discontinuation/reuse and subsequent observation require separate material.
The required direct details were not verified within the current stored-summary and unread-external-material scope. Event chronology, actual contact duration, discontinuation/re-exposure, collection windows/original cutoff and loss to follow-up are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original exposure/events, collection/discontinuation/recovery and timing material
Original material specifying actual time and safety follow-up for the same exposure
36 Unverified Full text not readStored summary read N36 · Evidence conditionWhat are the harm or alternative causes involving ingredients, retainers and baseline conditions?Supplementary; required for extension of harm questions
The original exposure concerns fluoride/carbonate-containing F-ACP and Essix. The summary lacks contributions from other ingredients/retainers, baseline oral conditions/exposures and possible events.
The required direct details were not verified within the current stored-summary and unread-external-material scope. Additives, baseline/concurrent conditions, other products, actual exposure, attribution/alternatives, vulnerable populations/long-term and rare harms are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original ingredients/products, baseline/concurrent conditions, event attribution and long-term/population-specific safety
If appropriate direct safety material is provided, distinguish differences from the original exposure/reporting scope
37 Partly verified Full text not readStored summary read N37 · Evidence conditionWhat is the original funding statement about no external funding?Required
The original evidence-list funding phrase 'This research received no external funding' and the Korean/English funding-check descriptions are retained. Original checked scope is distinguished from current reading.
Some information from the stored summary was linked for production. Original contracts, institutional/internal funding, sponsor/author roles, complete COI and data access are externally unread. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original funding/resources, design/collection/analysis/publication roles and COI material
If actual original declarations are provided, record checked levels/locations separately from unverified scope
38 Partly verified Full text not readStored summary read N38 · Evidence conditionDoes unverified product-provision wording differ from actual absence of provision?Required
The original records that trial-product provision wording was not identified in the publicly checked COI/acknowledgments. Parent I1 represents that historical checked scope.
Some information from the stored summary was linked for production. Complete product supply/in-kind support, author employment/patents, COI/acknowledgments, contracts and current changes are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original product-provision/contracts, COI/acknowledgments and role declarations
If original documents are provided, distinguish unverified/unreported status from the actual scope of provision/absence
39 Partly verified Full text not readStored summary read N39 · Evidence conditionWhat are the Korean/English texts, parent axes, false/null values and verdict history?Required
The parent C50/Good status, axes B/S/R1/I1/E+/B2, unrecorded precision, false coprimary-split/large hard-endpoint RCT/no-human-study flags and empty override reasons are preserved as originally recorded. Korean/English texts, synthesis, grade decisions and cross-checking are historical context.
Some information from the stored summary was linked for production. Original values/axes and historical checks were not inherited as current subclaim scores, condition fulfillment or completed review. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Separate preservation of subclaim/parent, original languages/axes/empty values and verdict history
If actual corrections are provided, distinguish complete original text, events/versions and decisions by scope
40 Partly verified Full text not readStored summary read N40 · Evidence conditionDo the reference date, corrections/empty values differ from production dates/scope?Required
The original reference date 2026-08-26, empty corrections/deliberation and the 2024 bibliography/unverified registration record are preserved. Current time belongs to a production event.
Some information from the stored summary was linked for production. Evidence reference-date/classification records are absent, and no registration/correction/retraction, new search/material or link comparison was performed. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Original publication/search/registration/correction versions and current production events
If material/corrections are actually provided, distinguish original scope, complete before/after text and new events
41 Partly verified Full text not readStored summary read N41 · Evidence conditionWhat are the boundaries between score benefits/reported harms and current applicability/product selection?Required
This sheet records ICDAS remineralization for the specified existing question and gaps in denominators/exposure, surrogates, safety and sponsorship in the same report. Individual dental products/use, treatment selection and current suitability are separate matters.
Some information from the stored summary was linked for production. Current products/guidelines, individual oral status, other compositions/controls and direct material on current benefit/harm applicability were not verified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Direct material for extended populations/exposures, clinical events/patient outcomes and harms, with applicability differences
If material is provided and the scope allows, update research gaps while distinguishing the original sheet from other applicability questions
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41 itemsWhat the statuses mean

Assessment scope

Stored-material review date
Not recorded
Original evidence cut-off
2026-08-26
Scope actually checked
Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean
This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population
White spots after orthodontic treatment; the original English term 'adolescents'; age, eligibility/exclusions and baseline lesion/tooth composition unverified
Ingredient, formulation and route
Original combined research exposure to fluoride/carbonate-containing amorphous calcium phosphate F-ACP mousse applied inside an Essix retainer
Dose
Only the nominal six months are retained; amount, frequency, actual contact, adherence and formulation details unverified. No product-use, conversion or dental administration instructions.
Comparator
Original control arm; the actual ingredient/concentration, fluoride/basic care and placebo/no-treatment definitions are absent from the specified existing review summary
Measured outcome
Six-month ICDAS white-spot lesion scores, with lower being better; original baseline, final, reduction and between-arm P distinguished. Patient/tooth/lesion aggregation unverified.
Duration
The six-month nominal exposure, score and adverse-effect reporting window are distinguished from actual individual follow-up, exposure and assessment windows
Questions outside this scope
Extending lesion scores to benefits in caries, fillings, teeth, daily life or patient satisfaction; Equating F-ACP with CPP-ACP, all fluoride products or the control fluoride definition; New calculations of lesion/tooth denominators, changes, differences, CIs, dropout or participant counts; Certifying no reported adverse effects or the original Good status as safety for all harms, long-term use or individuals; Instructions on product selection, amount, frequency, retainer care, dental treatment, suitability or substitution

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Ciribè M, et al. Biomedicines. 2024;12:1202. PMID: 38927409.

PubMed

Material type
Preserved original randomized-trial report summary
Materials actually read
Summary read; external abstracts, full texts and registrations unread
Findings recorded in the stored summary
Change 0.80 versus 0.39 points, between-arm P=0.003; lower is better
Record level
Historical funding/COI/acknowledgment and verdict-check descriptions; no current paper/plan reading
Study overlap and independent replication
The same Ciribè 2024/PMID38927409 trial: 106 allocated, 91 completers/52 and 39 participants, ICDAS baseline/six months, adverse effects and sibling prevention context. Lesions/teeth/repeated times are not new people or independent material; registration 'Not confirmed' is original history.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored summaryComplete original-byte copy of the stored summaryStored summary copy acquired and summary readSummary readThe complete parent/subclaims, original ICDAS values, denominators, sources/registration and safety history were read for production. This is not original-paper/registration reading.
External abstractExternal material unread; no access attemptsAccess not attempted; not obtainedNot readOnly the original PubMed bibliography URL is linked; no abstract acquisition/reading or link testing.
External full textExternal material unread; no access attemptsAccess not attempted; not obtainedNot readThe original URL establishes bibliographic identity, not certification of full-text access, acquisition or reading.
External registrationExternal material unread; no access attemptsAccess not attempted; not obtainedNot readThe original 'Not confirmed' record and null registration ID are retained. They are not converted to unregistered, nonexistence or access failure, and no URL is invented.
Required protocolNot acquired; detailed existence unverifiedAccess not attempted; not obtainedNot readOriginal eligibility, control fluoride, ingredients/exposure, ICDAS reading/timing and primary/secondary/change plans are needed.
Required analysis planNot acquired; detailed existence unverifiedAccess not attempted; not obtainedNot readOriginal material on patient/tooth/lesion units, aggregation/models, repeated measurements/clustering, missing data/denominators/CIs and importance is needed.
Required result tables and safety materialNot acquired; detailed existence unverifiedAccess not attempted; not obtainedNot readOriginal final/change/between-arm tables, dispersion/CIs, dropout/exposure, safety-reporting populations/times and attribution are needed.
Required funding and interestsNot acquired; detailed existence unverifiedAccess not attempted; not obtainedNot readNo external funding/unverified product wording are historical records. Complete declarations, product provision, sponsor/author roles are externally unread.

Report counts versus independent study counts

The same Ciribè 2024/PMID38927409 trial: 106 allocated, 91 completers/52 and 39 participants, ICDAS baseline/six months, adverse effects and sibling prevention context. Lesions/teeth/repeated times are not new people or independent material; registration 'Not confirmed' is original history.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which existing question and record are being presented in the sheet?
Required materials and conditions
Relationships among the original question, record and parent/sibling outcomes
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "Which existing question and record are being presented in the sheet?" to the corresponding original record. The original candidate-boundary review wait is historical information; no model content/boundary review was performed in this work.
Requirement and applicability
Required
Application exceptions
The original candidate-boundary review wait is historical information; no model content/boundary review was performed in this work. This gap is retained with the preservation scope, without new numbers, calculations or reassessment.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: Which existing question and record are being presented in the sheet?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C01
N02 · How are the subclaim C/note, parent C50 and missing scores/axes distinguished?
Required materials and conditions
A separate record of original subclaim/parent verdicts, notes, scores/axes and missing values
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "How are the subclaim C/note, parent C50 and missing scores/axes distinguished?" to the corresponding original record. There are no direct values for the selected subclaim score, status or axes.
Requirement and applicability
Required
Application exceptions
Do not create a uniform D grade, inherit the parent's 50 points/axes, or create current condition fulfillment or a new verdict.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: How are the subclaim C/note, parent C50 and missing scores/axes distinguished?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C01, C09
N03 · What is shared among one report, lesions/patients and sibling questions?
Required materials and conditions
Relationship table for bibliography/trial families, patients/teeth/lesions and times/outcomes
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is shared among one report, lesions/patients and sibling questions?" to the corresponding original record. Follow-up/other report versions, overlapping populations, lesion/tooth relationships and current unique trial/participant totals are unresolved.
Requirement and applicability
Required
Application exceptions
Do not count times, lesions/teeth, sibling sheets, the 106/91 participants or arm-specific participants as new participants or independent replications.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is shared among one report, lesions/patients and sibling questions?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C02, E07, H07
N04 · What are the actual summary-reading and external original-material statuses?
Required materials and conditions
Stored summaries and external original-material existence/acquisition, reading level and original locations
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the actual summary-reading and external original-material statuses?" to the corresponding original record. External public availability/acquisition, current content, access success and link operation were not verified.
Requirement and applicability
Required
Application exceptions
Do not upgrade summary reading to paper/registration reading or label no access attempt as access failure or absence of research.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the actual summary-reading and external original-material statuses?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C03
N05 · What is the scope of white spots after orthodontic treatment and the actual population?
Required materials and conditions
Original population eligibility/exclusions, baseline risk, age and orthodontic-status table
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is the scope of white spots after orthodontic treatment and the actual population?" to the corresponding original record. Age range, sex, baseline lesion/caries risk, orthodontic/retainer status, eligibility/exclusions and recruitment are unverified.
Requirement and applicability
Required
Application exceptions
Age range, sex, baseline lesion/caries risk, orthodontic/retainer status, eligibility/exclusions and recruitment are unverified. This gap is retained with the preservation scope, without new numbers, calculations or reassessment.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is the scope of white spots after orthodontic treatment and the actual population?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C04, E08
N06 · What are the baseline lesion/tooth distribution and assessment conditions?
Required materials and conditions
Original lesion/tooth distribution, selection criteria and assessment-environment/baseline table
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the baseline lesion/tooth distribution and assessment conditions?" to the corresponding original record. Teeth/surfaces, lesion counts, lesion criteria, photography/drying, orthodontic completion timing, assessment environment and baseline balance are unverified.
Requirement and applicability
Required
Application exceptions
Teeth/surfaces, lesion counts, lesion criteria, photography/drying, orthodontic completion timing, assessment environment and baseline balance are unverified. This gap is retained with the preservation scope, without new numbers, calculations or reassessment.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the baseline lesion/tooth distribution and assessment conditions?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C04, E03, C06
N07 · What are the original F-ACP ingredients and the other CPP-ACP product families?
Required materials and conditions
Trial-product identity, composition/concentration and original product/provision information
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the original F-ACP ingredients and the other CPP-ACP product families?" to the corresponding original record. The finished trial product/manufacturer, ingredient concentrations, other additives, batches, provision/quality and equivalence between products are unverified.
Requirement and applicability
Required
Application exceptions
Do not equate F-ACP with CPP-ACP or all fluoride products, or convert product-family marketing into clinical-event evidence for this trial.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the original F-ACP ingredients and the other CPP-ACP product families?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C05, E08
N08 · What is the scope of six-month research exposure inside an Essix retainer?
Required materials and conditions
Original product/retainer exposure, nominal/actual use and adherence/change material
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is the scope of six-month research exposure inside an Essix retainer?" to the corresponding original record. Application amount, frequency, retainer wear/cleaning, actual adherence, discontinuations/changes, contact time and route details are unverified.
Requirement and applicability
Required
Application exceptions
Do not turn the original research exposure into product-use instructions, retainer care, dose/frequency conversions or individual treatment guidance.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is the scope of six-month research exposure inside an Essix retainer?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C05, E02, E08
N09 · Were the control arm's fluoride and basic treatment conditions directly reported?
Required materials and conditions
Original control treatment, product/concentration, common/arm-specific care and actual implementation
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "Were the control arm's fluoride and basic treatment conditions directly reported?" to the corresponding original record. Direct definitions of control-arm fluoride/toothpaste, retainers, placebo/no treatment, hygiene/diet and common/arm-specific care are unverified.
Requirement and applicability
Required
Application exceptions
Do not generate fluoride-control ingredients/concentrations, placebo/no-treatment definitions or use frequency absent from the existing review summary.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: Were the control arm's fluoride and basic treatment conditions directly reported?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C05, E02
N10 · What are the denominators for 106 randomized, 91 completers and 52/39 participants?
Required materials and conditions
Allocation → exposure → completion/assessment → analysis, and patient/lesion denominator tables
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the denominators for 106 randomized, 91 completers and 52/39 participants?" to the corresponding original record. Randomized n by arm, selection/exposure/completion/assessment flow, tooth/lesion counts and original counts by exclusion reason are unverified.
Requirement and applicability
Required
Application exceptions
Do not infer arm allocation from 106 participants or convert 52/39 into tooth/lesion counts.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the denominators for 106 randomized, 91 completers and 52/39 participants?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C07, E04
N11 · What is the scope of the original 14.2% dropout and completer selection?
Required materials and conditions
Original dropout/exclusion, follow-up, baseline/missing-data handling and analysis flow
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is the scope of the original 14.2% dropout and completer selection?" to the corresponding original record. Arm-specific dropout/nonadherence, timing/reasons, dropout baseline/outcomes, missing-data handling and sensitivity are unverified.
Requirement and applicability
Required
Application exceptions
Do not calculate new dropout counts from 106−91 or copy the original 14.2% as each arm's dropout rate.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is the scope of the original 14.2% dropout and completer selection?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C07, E04, H06
N12 · What are the original randomization, concealment and design details?
Required materials and conditions
Original allocation/design, concealment, baseline tables and implementation material
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the original randomization, concealment and design details?" to the corresponding original record. The summary lacks parallel/cluster/crossover design, random-sequence/allocation concealment, baseline balance and implementation-role details.
Requirement and applicability
Required
Application exceptions
Do not arbitrarily mark cluster/crossover design as not applicable or fill all design details from the parent B2 axis.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the original randomization, concealment and design details?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E01
N13 · What are the ICDAS assessment, masking and measurement reliability?
Required materials and conditions
Original ICDAS criteria, assessors/masking, measurement conditions and reliability material
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the ICDAS assessment, masking and measurement reliability?" to the corresponding original record. ICDAS version, assessors/calibration, masking, photographs/examinations, inter-assessment agreement, missing assessments and arm differences are unverified.
Requirement and applicability
Required
Application exceptions
ICDAS version, assessors/calibration, masking, photographs/examinations, inter-assessment agreement, missing assessments and arm differences are unverified. This gap is retained with the preservation scope, without new numbers, calculations or reassessment.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the ICDAS assessment, masking and measurement reliability?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E03, C06
N14 · Are patient, tooth and lesion units distinguished from repeated measurements?
Required materials and conditions
Patient–tooth–lesion relationships, aggregation/models and unit-specific denominator/measurement tables
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "Are patient, tooth and lesion units distinguished from repeated measurements?" to the corresponding original record. ICDAS aggregation units, lesions per patient, selected teeth/surfaces, cluster/repeated-measure handling and denominators are unverified.
Requirement and applicability
Required
Application exceptions
Do not transfer 91 patients or 52/39 participants to lesion/tooth denominators, or add repeated measurements/lesion counts as independent samples.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: Are patient, tooth and lesion units distinguished from repeated measurements?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C02, C06, C07, E04
N15 · What are six-month ICDAS, nominal exposure and assessment timing?
Required materials and conditions
Original schedules, baseline/six months, actual exposure/assessment and missing-data material
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are six-month ICDAS, nominal exposure and assessment timing?" to the corresponding original record. Orthodontic completion/baseline, final assessment timing, allowed windows, intermediate times, data cutoff and actual exposure/safety follow-up are unverified.
Requirement and applicability
Required
Application exceptions
Do not present six months as identical actual exposure/complete follow-up for every patient or invent intermediate effects absent from original material.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are six-month ICDAS, nominal exposure and assessment timing?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C06, E03, E08
N16 · What is the original direction of baseline and six-month final values?
Required materials and conditions
Original baseline/final tables, aggregation/dispersion, units/denominators and models
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is the original direction of baseline and six-month final values?" to the corresponding original record. Details of each value's mean/median, dispersion/CI, aggregation/measurement unit, adjustment and original timing are unverified.
Requirement and applicability
Required
Application exceptions
Do not newly subtract baseline/final values or infer their dispersion/CIs or original control conditions.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is the original direction of baseline and six-month final values?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C06, E04, E05
N17 · What do changes of 0.80 versus 0.39 points represent?
Required materials and conditions
Original change definitions, sign/units, dispersion, analysis methods and tables
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What do changes of 0.80 versus 0.39 points represent?" to the corresponding original record. Details of sign/aggregation, change dispersion, paired measurements/adjustment and within-arm versus between-arm tests are unverified.
Requirement and applicability
Required
Application exceptions
Do not turn reductions of 0.80/0.39 into ICDAS increases or individual amounts of healing, or calculate new relative changes/effects.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What do changes of 0.80 versus 0.39 points represent?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C06, E04, E05
N18 · What is the level of the original 0.41-point difference in change?
Required materials and conditions
Original between-arm change differences, models/units and CI/criterion tables
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is the level of the original 0.41-point difference in change?" to the corresponding original record. Adjustment, dispersion/CI, aggregation/clustering/repeated measurements and clinical-importance criteria are unverified.
Requirement and applicability
Required
Application exceptions
Use 0.41 points only as the original value; do not derive final-value differences, change ratios or new CIs.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is the level of the original 0.41-point difference in change?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E04, E05, C06
N19 · What are between-arm P=0.003 and the effect interval?
Required materials and conditions
Original statistical methods, test targets, effects/CIs and unit material
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are between-arm P=0.003 and the effect interval?" to the corresponding original record. Original tests/models, CIs, dispersion, multiplicity, measurement/analysis units and importance are unverified.
Requirement and applicability
Required
Application exceptions
Do not newly infer guaranteed individual remineralization, reduced caries or all forms of importance/clinical superiority from P=.003 alone.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are between-arm P=0.003 and the effect interval?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E05, E04
N20 · What are score aggregation, models and within-arm/between-arm analyses?
Required materials and conditions
Original score aggregation/statistical methods, SAP, models/units and tables
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are score aggregation, models and within-arm/between-arm analyses?" to the corresponding original record. Scale treatment, aggregation, baseline adjustment, clustering/repeated measurements, analysis assumptions, sensitivity and change dispersion are unverified.
Requirement and applicability
Required
Application exceptions
Do not arbitrarily declare scores interval-scaled/normally distributed or models, adjustment or clustering not applicable.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are score aggregation, models and within-arm/between-arm analyses?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E04, C06
N21 · How do completer effects differ from effects in the full randomized population?
Required materials and conditions
Original analysis populations, completion/exclusions, missing-data assumptions and alternative analyses
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "How do completer effects differ from effects in the full randomized population?" to the corresponding original record. Allocation/adherence effects, completion selection, arm-specific exclusions and original ITT/sensitivity outcomes are unverified.
Requirement and applicability
Required
Application exceptions
Do not turn completer analysis into full-population ITT or create new ITT values/bias magnitudes from the parent's explanation of avoidability.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: How do completer effects differ from effects in the full randomized population?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E04, C07
N22 · What are the reported intervals and criteria for an important ICDAS difference?
Required materials and conditions
Original importance/clinical-linkage criteria, effect intervals and planning assumptions
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the reported intervals and criteria for an important ICDAS difference?" to the corresponding original record. Minimum important differences, stage/lesion-recovery criteria, intervals/dispersion and power/original plans are unverified.
Requirement and applicability
Required
Application exceptions
Do not automatically use 0.41 points, statistical positivity or parent C50 as criteria establishing patient-important effects.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the reported intervals and criteria for an important ICDAS difference?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E05, E09
N23 · What do registration 'Not confirmed', prespecification and plans mean?
Required materials and conditions
Original registration/plans, endpoints/times, analysis versions and change material
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What do registration 'Not confirmed', prespecification and plans mean?" to the corresponding original record. Registration/protocol/SAP, original primary/secondary outcomes, analyses/times and change history are externally unread.
Requirement and applicability
Required
Application exceptions
Do not convert 'Not confirmed' into unregistered/no registration, access failure or confirmed selective reporting.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What do registration 'Not confirmed', prespecification and plans mean?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E06, C09
N24 · What is the scope of multiplicity and disclosure of all outcomes/times?
Required materials and conditions
Protocol/SAP, all outcomes/times and reporting/change tables
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is the scope of multiplicity and disclosure of all outcomes/times?" to the corresponding original record. Full outcome lists, multiplicity adjustment, exploratory/confirmatory status, prespecified analyses/changes and unpublished outcomes are unverified.
Requirement and applicability
Required
Application exceptions
Do not certify that all endpoints/times match plans or that selective reporting is absent from P=.003 and a single report.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is the scope of multiplicity and disclosure of all outcomes/times?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E06, C08
N25 · What are the original verdict and unmeasured scope for sibling caries prevention?
Required materials and conditions
The same trial's outcome list and direct clinical-event material for the prevention question
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the original verdict and unmeasured scope for sibling caries prevention?" to the corresponding original record. Original clinical-event definitions/collection, long-term outcomes, registration plans and current related material were not verified in this work.
Requirement and applicability
Required
Application exceptions
Do not turn the sibling '?' into D or upgrade the original unmeasured description to zero prevention studies worldwide, zero effect or current full-text verification.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the original verdict and unmeasured scope for sibling caries prevention?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E09, C08
N26 · Does ICDAS remineralization also answer questions about new caries, fillings or tooth loss?
Required materials and conditions
Direct definitions, denominators and durations for new caries/treatment and tooth outcomes, with related validation
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "Does ICDAS remineralization also answer questions about new caries, fillings or tooth loss?" to the corresponding original record. Direct clinical-event effects, units/denominators, duration, surrogate prediction/mediation and long-term material are unverified.
Requirement and applicability
Required
Application exceptions
Do not extend positive remineralization/lesion scores to established caries prevention, avoidance of filling treatment or all dental-health benefits.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: Does ICDAS remineralization also answer questions about new caries, fillings or tooth loss?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E09, E08
N27 · Are visual improvement and benefits in patient appearance/daily life the same?
Required materials and conditions
Patient-centered outcomes/scales, definitions, denominators/times and original results
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "Are visual improvement and benefits in patient appearance/daily life the same?" to the corresponding original record. Patient-reported appearance/satisfaction, daily life/quality of life, symptoms, persistence, importance and denominators are unverified.
Requirement and applicability
Supplementary; required for extension to daily-life benefits
Application exceptions
Do not turn the original possibility of usefulness into verified patient satisfaction, daily-life improvement or cosmetic effects.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: Are visual improvement and benefits in patient appearance/daily life the same?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E09, E08
N28 · What are the concurrent or alternative effects of hygiene, fluoride, diet and retainers?
Required materials and conditions
Control/concurrent treatment, actual behavior/adherence and original baseline/analysis material
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the concurrent or alternative effects of hygiene, fluoride, diet and retainers?" to the corresponding original record. Arm-specific concurrent fluoride/toothpaste, diet/hygiene, retainers, natural course, intervention/assessment differences and handling methods are unverified.
Requirement and applicability
Required
Application exceptions
Do not declare all care identical or other causes absent from missing information, or generate oral-care instructions for users.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the concurrent or alternative effects of hygiene, fluoride, diet and retainers?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E02, H05
N29 · What are actual adherence, discontinuations and duration/dose comparisons?
Required materials and conditions
Original adherence/changes, exposure and direct-comparison/SAP material
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are actual adherence, discontinuations and duration/dose comparisons?" to the corresponding original record. Adherence measurement/distribution, discontinuations/changes, actual contact/amount and direct frequency/duration/formulation comparisons are unverified.
Requirement and applicability
Required
Application exceptions
Do not turn nominal six-month exposure into optimal duration/frequency, retainer-care or product-use recommendations.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are actual adherence, discontinuations and duration/dose comparisons?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E02, E08
N30 · What direct material addresses other populations, subgroups and long-term maintenance?
Required materials and conditions
Extended populations/exposures, prespecified subgroups and duration-specific direct outcomes
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What direct material addresses other populations, subgroups and long-term maintenance?" to the corresponding original record. Prespecified subgroups/interactions, direct population/product comparisons, longer follow-up and persistence after stopping are unverified.
Requirement and applicability
Supplementary; required for extension
Application exceptions
Prespecified subgroups/interactions, direct population/product comparisons, longer follow-up and persistence after stopping are unverified. This gap is retained with the preservation scope, without new numbers, calculations or reassessment.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What direct material addresses other populations, subgroups and long-term maintenance?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E08, E07
N31 · Do single-trial/R1/I1 history and current independent replication differ?
Required materials and conditions
Report/trial/population, product/source and outcome relationships, with direct independent material
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "Do single-trial/R1/I1 history and current independent replication differ?" to the corresponding original record. Current additional/follow-up reports, direct replication in other populations/products and material-family/independence relationships were not newly searched.
Requirement and applicability
Required
Application exceptions
Do not inherit a single trial/R1 and historical I1 as current worldwide trial counts or passed independence, or count outcomes/times as independent replications.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: Do single-trial/R1/I1 history and current independent replication differ?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C02, E07, C10, H07
N32 · What history is represented by the original small-study/completer and duration defect descriptions?
Required materials and conditions
Complete parent-verdict history and actual design/analysis material
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What history is represented by the original small-study/completer and duration defect descriptions?" to the corresponding original record. These case-specific conditions did not automatically adopt the original 200 participants/12 weeks as minimum criteria or reassess them as new defect scores.
Requirement and applicability
Required
Application exceptions
Do not copy parent checklist criteria as universal participant/duration rules for new conditions, current completed review or reassessment.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What history is represented by the original small-study/completer and duration defect descriptions?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C09, E04, E05
N33 · What is the scope of no patient/guardian-reported adverse effects over six months?
Required materials and conditions
Original adverse-effect reporting/collection, population/duration and definition/discontinuation material
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is the scope of no patient/guardian-reported adverse effects over six months?" to the corresponding original record. Event definitions, systematic/spontaneous collection, grades/discontinuations, original safety denominators and actual records/verification are unverified.
Requirement and applicability
Required
Application exceptions
Do not extend a no-reports sentence to zero events of all kinds, complete collection, individual harmlessness or long-term safety certification.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is the scope of no patient/guardian-reported adverse effects over six months?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E10, H01, H09
N34 · What are the adverse-effect denominators, dropout and reporting selection?
Required materials and conditions
Original safety-population/exposure, collection/missing reports and dropout/follow-up tables
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the adverse-effect denominators, dropout and reporting selection?" to the corresponding original record. Safety populations, reporting/exposure/follow-up, events among dropouts, missing reports/recall and arm-specific detection differences are unverified.
Requirement and applicability
Required
Application exceptions
Do not fill verified safety denominators with the 91 efficacy participants or 106 randomized participants, or calculate new incidence/intervals from no reports.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the adverse-effect denominators, dropout and reporting selection?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions H04, H06, C07
N35 · What are harm occurrence, discontinuation and exposure/follow-up times?
Required materials and conditions
Original exposure/events, collection/discontinuation/recovery and timing material
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are harm occurrence, discontinuation and exposure/follow-up times?" to the corresponding original record. Event chronology, actual contact duration, discontinuation/re-exposure, collection windows/original cutoff and loss to follow-up are unverified.
Requirement and applicability
Required
Application exceptions
Do not transfer nominal six-month exposure/reporting to complete individual harm observation or future safety.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are harm occurrence, discontinuation and exposure/follow-up times?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions H02, H04
N36 · What are the harm or alternative causes involving ingredients, retainers and baseline conditions?
Required materials and conditions
Original ingredients/products, baseline/concurrent conditions, event attribution and long-term/population-specific safety
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the harm or alternative causes involving ingredients, retainers and baseline conditions?" to the corresponding original record. Additives, baseline/concurrent conditions, other products, actual exposure, attribution/alternatives, vulnerable populations/long-term and rare harms are unverified.
Requirement and applicability
Supplementary; required for extension of harm questions
Application exceptions
Do not exclude all events such as allergy/ingredient harms or generate product-suitability/use recommendations from no reports alone.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the harm or alternative causes involving ingredients, retainers and baseline conditions?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions H05, H08, E10
N37 · What is the original funding statement about no external funding?
Required materials and conditions
Original funding/resources, design/collection/analysis/publication roles and COI material
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is the original funding statement about no external funding?" to the corresponding original record. Original contracts, institutional/internal funding, sponsor/author roles, complete COI and data access are externally unread.
Requirement and applicability
Required
Application exceptions
Do not certify absence of all funding/product/company involvement or COI, or completed current independence from the no-external-funding quotation.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is the original funding statement about no external funding?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C10
N38 · Does unverified product-provision wording differ from actual absence of provision?
Required materials and conditions
Original product-provision/contracts, COI/acknowledgments and role declarations
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "Does unverified product-provision wording differ from actual absence of provision?" to the corresponding original record. Complete product supply/in-kind support, author employment/patents, COI/acknowledgments, contracts and current changes are unverified.
Requirement and applicability
Required
Application exceptions
Do not convert unconfirmed wording into no product provision, external access failure or current independence certification.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: Does unverified product-provision wording differ from actual absence of provision?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C10, C09
N39 · What are the Korean/English texts, parent axes, false/null values and verdict history?
Required materials and conditions
Separate preservation of subclaim/parent, original languages/axes/empty values and verdict history
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the Korean/English texts, parent axes, false/null values and verdict history?" to the corresponding original record. Original values/axes and historical checks were not inherited as current subclaim scores, condition fulfillment or completed review.
Requirement and applicability
Required
Application exceptions
Do not fill unrecorded precision with 0 or declare parent B2, historical checking/cross-checking as newly completed model review or subclaim scores.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the Korean/English texts, parent axes, false/null values and verdict history?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C01, C09, E06
N40 · Do the reference date, corrections/empty values differ from production dates/scope?
Required materials and conditions
Original publication/search/registration/correction versions and current production events
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "Do the reference date, corrections/empty values differ from production dates/scope?" to the corresponding original record. Evidence reference-date/classification records are absent, and no registration/correction/retraction, new search/material or link comparison was performed.
Requirement and applicability
Required
Application exceptions
Do not borrow empty corrections/the original reference date as current absence of corrections or this work's review date, or label no search as zero studies.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: Do the reference date, corrections/empty values differ from production dates/scope?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C09, C03
N41 · What are the boundaries between score benefits/reported harms and current applicability/product selection?
Required materials and conditions
Direct material for extended populations/exposures, clinical events/patient outcomes and harms, with applicability differences
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the boundaries between score benefits/reported harms and current applicability/product selection?" to the corresponding original record. Current products/guidelines, individual oral status, other compositions/controls and direct material on current benefit/harm applicability were not verified.
Requirement and applicability
Required
Application exceptions
Do not extend C/positive scores, the original Good status or no reported adverse effects to caries prevention/daily-life benefits, individual safety/suitability or product-use/selection/administration recommendations.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the boundaries between score benefits/reported harms and current applicability/product selection?
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions H09, E09, E08, C09
Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle
Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review
Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle
Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review
Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle
Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review
Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle
Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review
Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle
Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review
Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
What the statuses mean
Met
The original content has been reviewed as meeting the conditions. This status is not used in this preparation.
Partly verified
Some information in the stored summary was linked during preparation; clinical verification or review is not complete.
Unverified
Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.
Review incomplete
Review of existing content or actual review incomplete.
Not reported
Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.
Inaccessible
Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.
Insufficient evidence for the conditions
Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.
Not applicable
Used when the reason it does not apply to the original question is stated.
Conflicting data
Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment.

Change history

2026-10-10 · Public page/material version 1.0

The reader view and materials were prepared from the existing 41 items. No new clinical search, verification-status changes or scoring were performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which existing question and record are being presented in the sheet?

Current findings
The selected question is 'ICDAS remineralization of white spots'; the question and existing verdict record are distinguished. The parent concerns lesion remineralization after orthodontic treatment, while the sibling concerns a different outcome, prevention of incident caries.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. The original candidate-boundary review wait is historical information; no model content/boundary review was performed in this work. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
The original candidate-boundary review wait is historical information; no model content/boundary review was performed in this work.
Required materials and conditions
Relationships among the original question, record and parent/sibling outcomes
Materials to obtain first
Relationships among the original question, record and parent/sibling outcomes
Further research
If additional material is provided, a linked outcome text retaining the original existing question and its connection
Remaining uncertainty
The original candidate-boundary review wait is historical information; no model content/boundary review was performed in this work.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "Which existing question and record are being presented in the sheet?" to the corresponding original record. The original candidate-boundary review wait is historical information; no model content/boundary review was performed in this work.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: Which existing question and record are being presented in the sheet?
Application exceptions
The original candidate-boundary review wait is historical information; no model content/boundary review was performed in this work. This gap is retained with the preservation scope, without new numbers, calculations or reassessment.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C01

Related sources R01

N02 · How are the subclaim C/note, parent C50 and missing scores/axes distinguished?

Current findings
The original subclaim grade C and note 'Score improvement was confirmed' are retained. Subclaim scores/status/axes are absent; the parent C50, Good status and axes are parent history.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. There are no direct values for the selected subclaim score, status or axes. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
There are no direct values for the selected subclaim score, status or axes.
Required materials and conditions
A separate record of original subclaim/parent verdicts, notes, scores/axes and missing values
Materials to obtain first
A separate record of original subclaim/parent verdicts, notes, scores/axes and missing values
Further research
If an actual verdict correction is provided, separate the complete original text, event/version and change decision
Remaining uncertainty
There are no direct values for the selected subclaim score, status or axes.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "How are the subclaim C/note, parent C50 and missing scores/axes distinguished?" to the corresponding original record. There are no direct values for the selected subclaim score, status or axes.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: How are the subclaim C/note, parent C50 and missing scores/axes distinguished?
Application exceptions
Do not create a uniform D grade, inherit the parent's 50 points/axes, or create current condition fulfillment or a new verdict.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C01, C09

Related sources R01

N03 · What is shared among one report, lesions/patients and sibling questions?

Current findings
Ciribè et al. 2024, PMID38927409, occupies 1 slot in each evidence/citation list. The same trial's patients, lesions/teeth, baseline/six months, safety and unmeasured caries-prevention context are linked.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Follow-up/other report versions, overlapping populations, lesion/tooth relationships and current unique trial/participant totals are unresolved. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Follow-up/other report versions, overlapping populations, lesion/tooth relationships and current unique trial/participant totals are unresolved.
Required materials and conditions
Relationship table for bibliography/trial families, patients/teeth/lesions and times/outcomes
Materials to obtain first
Relationship table for bibliography/trial families, patients/teeth/lesions and times/outcomes
Further research
If additional reports are provided, distinguish relationships among the same populations/reports/outcomes and separate material
Remaining uncertainty
Follow-up/other report versions, overlapping populations, lesion/tooth relationships and current unique trial/participant totals are unresolved.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is shared among one report, lesions/patients and sibling questions?" to the corresponding original record. Follow-up/other report versions, overlapping populations, lesion/tooth relationships and current unique trial/participant totals are unresolved.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is shared among one report, lesions/patients and sibling questions?
Application exceptions
Do not count times, lesions/teeth, sibling sheets, the 106/91 participants or arm-specific participants as new participants or independent replications.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C02, E07, H07

Related sources R01

N04 · What are the actual summary-reading and external original-material statuses?

Current findings
The complete specified stored summary was read for production and the original was preserved. The original PubMed URL is only linked; external abstracts, full texts, registrations and plans are unread.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. External public availability/acquisition, current content, access success and link operation were not verified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
External public availability/acquisition, current content, access success and link operation were not verified.
Required materials and conditions
Stored summaries and external original-material existence/acquisition, reading level and original locations
Materials to obtain first
Stored summaries and external original-material existence/acquisition, reading level and original locations
Further research
When further acquisition is allowed, record actual reading/attempts and dates separately
Remaining uncertainty
External public availability/acquisition, current content, access success and link operation were not verified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the actual summary-reading and external original-material statuses?" to the corresponding original record. External public availability/acquisition, current content, access success and link operation were not verified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the actual summary-reading and external original-material statuses?
Application exceptions
Do not upgrade summary reading to paper/registration reading or label no access attempt as access failure or absence of research.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C03

Related sources R01

N05 · What is the scope of white spots after orthodontic treatment and the actual population?

Current findings
The original question concerns white spots after orthodontic treatment, and the existing English research description says 'randomized adolescents'. Each Korean/English population wording is preserved as recorded.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Age range, sex, baseline lesion/caries risk, orthodontic/retainer status, eligibility/exclusions and recruitment are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Age range, sex, baseline lesion/caries risk, orthodontic/retainer status, eligibility/exclusions and recruitment are unverified.
Required materials and conditions
Original population eligibility/exclusions, baseline risk, age and orthodontic-status table
Materials to obtain first
Original population eligibility/exclusions, baseline risk, age and orthodontic-status table
Further research
Same-trial material specifying the selected population and direct outcomes, or appropriate separate material
Remaining uncertainty
Age range, sex, baseline lesion/caries risk, orthodontic/retainer status, eligibility/exclusions and recruitment are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is the scope of white spots after orthodontic treatment and the actual population?" to the corresponding original record. Age range, sex, baseline lesion/caries risk, orthodontic/retainer status, eligibility/exclusions and recruitment are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is the scope of white spots after orthodontic treatment and the actual population?
Application exceptions
Age range, sex, baseline lesion/caries risk, orthodontic/retainer status, eligibility/exclusions and recruitment are unverified. This gap is retained with the preservation scope, without new numbers, calculations or reassessment.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C04, E08

Related sources R01

N06 · What are the baseline lesion/tooth distribution and assessment conditions?

Current findings
The original material presents patient counts and arm-specific baseline/six-month ICDAS values, but no separate lesion location, tooth/patient distribution or assessment environment.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
The required direct details were not verified within the current stored-summary and unread-external-material scope. Teeth/surfaces, lesion counts, lesion criteria, photography/drying, orthodontic completion timing, assessment environment and baseline balance are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Teeth/surfaces, lesion counts, lesion criteria, photography/drying, orthodontic completion timing, assessment environment and baseline balance are unverified.
Required materials and conditions
Original lesion/tooth distribution, selection criteria and assessment-environment/baseline table
Materials to obtain first
Original lesion/tooth distribution, selection criteria and assessment-environment/baseline table
Further research
Original material linking patient/lesion baseline status to measurement conditions
Remaining uncertainty
Teeth/surfaces, lesion counts, lesion criteria, photography/drying, orthodontic completion timing, assessment environment and baseline balance are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the baseline lesion/tooth distribution and assessment conditions?" to the corresponding original record. Teeth/surfaces, lesion counts, lesion criteria, photography/drying, orthodontic completion timing, assessment environment and baseline balance are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the baseline lesion/tooth distribution and assessment conditions?
Application exceptions
Teeth/surfaces, lesion counts, lesion criteria, photography/drying, orthodontic completion timing, assessment environment and baseline balance are unverified. This gap is retained with the preservation scope, without new numbers, calculations or reassessment.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C04, E03, C06

Related sources R01

N07 · What are the original F-ACP ingredients and the other CPP-ACP product families?

Current findings
The existing product information states that F-ACP is an amorphous calcium phosphate complex containing fluoride and carbonate. Marketing of fluoride/CPP-ACP product families in the existing advertising interpretation is a different-product-family context.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. The finished trial product/manufacturer, ingredient concentrations, other additives, batches, provision/quality and equivalence between products are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
The finished trial product/manufacturer, ingredient concentrations, other additives, batches, provision/quality and equivalence between products are unverified.
Required materials and conditions
Trial-product identity, composition/concentration and original product/provision information
Materials to obtain first
Trial-product identity, composition/concentration and original product/provision information
Further research
Material specifying applicability differences between the actual trial product and other compositions/products
Remaining uncertainty
The finished trial product/manufacturer, ingredient concentrations, other additives, batches, provision/quality and equivalence between products are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the original F-ACP ingredients and the other CPP-ACP product families?" to the corresponding original record. The finished trial product/manufacturer, ingredient concentrations, other additives, batches, provision/quality and equivalence between products are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the original F-ACP ingredients and the other CPP-ACP product families?
Application exceptions
Do not equate F-ACP with CPP-ACP or all fluoride products, or convert product-family marketing into clinical-event evidence for this trial.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C05, E08

Related sources R01

N08 · What is the scope of six-month research exposure inside an Essix retainer?

Current findings
The original research condition involved applying mousse inside an Essix retainer for six months. The combined product, retainer and duration exposure is recorded as originally stated.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Application amount, frequency, retainer wear/cleaning, actual adherence, discontinuations/changes, contact time and route details are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Application amount, frequency, retainer wear/cleaning, actual adherence, discontinuations/changes, contact time and route details are unverified.
Required materials and conditions
Original product/retainer exposure, nominal/actual use and adherence/change material
Materials to obtain first
Original product/retainer exposure, nominal/actual use and adherence/change material
Further research
Original implementation material linking actual exposure and outcomes in the same study
Remaining uncertainty
Application amount, frequency, retainer wear/cleaning, actual adherence, discontinuations/changes, contact time and route details are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is the scope of six-month research exposure inside an Essix retainer?" to the corresponding original record. Application amount, frequency, retainer wear/cleaning, actual adherence, discontinuations/changes, contact time and route details are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is the scope of six-month research exposure inside an Essix retainer?
Application exceptions
Do not turn the original research exposure into product-use instructions, retainer care, dose/frequency conversions or individual treatment guidance.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C05, E02, E08

Related sources R01

N09 · Were the control arm's fluoride and basic treatment conditions directly reported?

Current findings
The existing verdict rationale records control-arm ICDAS values, but the specified summary contains no control product/fluoride ingredients, concentrations or exposure. F-ACP's fluoride ingredients and product-family marketing are not control treatment.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
The required direct details were not verified within the current stored-summary and unread-external-material scope. Direct definitions of control-arm fluoride/toothpaste, retainers, placebo/no treatment, hygiene/diet and common/arm-specific care are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Direct definitions of control-arm fluoride/toothpaste, retainers, placebo/no treatment, hygiene/diet and common/arm-specific care are unverified.
Required materials and conditions
Original control treatment, product/concentration, common/arm-specific care and actual implementation
Materials to obtain first
Original control treatment, product/concentration, common/arm-specific care and actual implementation
Further research
Protocol/report specifying the actual control and concurrent conditions in the same trial
Remaining uncertainty
Direct definitions of control-arm fluoride/toothpaste, retainers, placebo/no treatment, hygiene/diet and common/arm-specific care are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "Were the control arm's fluoride and basic treatment conditions directly reported?" to the corresponding original record. Direct definitions of control-arm fluoride/toothpaste, retainers, placebo/no treatment, hygiene/diet and common/arm-specific care are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: Were the control arm's fluoride and basic treatment conditions directly reported?
Application exceptions
Do not generate fluoride-control ingredients/concentrations, placebo/no-treatment definitions or use frequency absent from the existing review summary.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C05, E02

Related sources R01

N10 · What are the denominators for 106 randomized, 91 completers and 52/39 participants?

Current findings
The original n is 106 randomized and 91 completers analyzed; the existing Korean research description records 52 mousse and 39 control participants. Each number is an original patient-denominator record.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Randomized n by arm, selection/exposure/completion/assessment flow, tooth/lesion counts and original counts by exclusion reason are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Randomized n by arm, selection/exposure/completion/assessment flow, tooth/lesion counts and original counts by exclusion reason are unverified.
Required materials and conditions
Allocation → exposure → completion/assessment → analysis, and patient/lesion denominator tables
Materials to obtain first
Allocation → exposure → completion/assessment → analysis, and patient/lesion denominator tables
Further research
Same-trial material linking arm-specific flow to original denominators for each unit
Remaining uncertainty
Randomized n by arm, selection/exposure/completion/assessment flow, tooth/lesion counts and original counts by exclusion reason are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the denominators for 106 randomized, 91 completers and 52/39 participants?" to the corresponding original record. Randomized n by arm, selection/exposure/completion/assessment flow, tooth/lesion counts and original counts by exclusion reason are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the denominators for 106 randomized, 91 completers and 52/39 participants?
Application exceptions
Do not infer arm allocation from 106 participants or convert 52/39 into tooth/lesion counts.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C07, E04

Related sources R01

N11 · What is the scope of the original 14.2% dropout and completer selection?

Current findings
The original records 91/106, 14.2% dropout and completer analysis. Dropout rates, analysis inclusion and original observation/exposure are distinguished.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Arm-specific dropout/nonadherence, timing/reasons, dropout baseline/outcomes, missing-data handling and sensitivity are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Arm-specific dropout/nonadherence, timing/reasons, dropout baseline/outcomes, missing-data handling and sensitivity are unverified.
Required materials and conditions
Original dropout/exclusion, follow-up, baseline/missing-data handling and analysis flow
Materials to obtain first
Original dropout/exclusion, follow-up, baseline/missing-data handling and analysis flow
Further research
Same-trial material specifying completer/noncompleter data and original analysis assumptions
Remaining uncertainty
Arm-specific dropout/nonadherence, timing/reasons, dropout baseline/outcomes, missing-data handling and sensitivity are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is the scope of the original 14.2% dropout and completer selection?" to the corresponding original record. Arm-specific dropout/nonadherence, timing/reasons, dropout baseline/outcomes, missing-data handling and sensitivity are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is the scope of the original 14.2% dropout and completer selection?
Application exceptions
Do not calculate new dropout counts from 106−91 or copy the original 14.2% as each arm's dropout rate.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C07, E04, H06

Related sources R01

N12 · What are the original randomization, concealment and design details?

Current findings
The evidence-list design is a randomized controlled trial. Actual allocation, concealment and baseline-balance details require material separately from the original subclaim/parent verdicts.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. The summary lacks parallel/cluster/crossover design, random-sequence/allocation concealment, baseline balance and implementation-role details. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
The summary lacks parallel/cluster/crossover design, random-sequence/allocation concealment, baseline balance and implementation-role details.
Required materials and conditions
Original allocation/design, concealment, baseline tables and implementation material
Materials to obtain first
Original allocation/design, concealment, baseline tables and implementation material
Further research
Material specifying the actual comparative design in the protocol/report
Remaining uncertainty
The summary lacks parallel/cluster/crossover design, random-sequence/allocation concealment, baseline balance and implementation-role details.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the original randomization, concealment and design details?" to the corresponding original record. The summary lacks parallel/cluster/crossover design, random-sequence/allocation concealment, baseline balance and implementation-role details.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the original randomization, concealment and design details?
Application exceptions
Do not arbitrarily mark cluster/crossover design as not applicable or fill all design details from the parent B2 axis.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E01

Related sources R01

N13 · What are the ICDAS assessment, masking and measurement reliability?

Current findings
The original endpoint is the six-month ICDAS white-spot score. The original indicates greater lesion severity with higher scores, but assessors/masking and examination conditions are separate matters.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. ICDAS version, assessors/calibration, masking, photographs/examinations, inter-assessment agreement, missing assessments and arm differences are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
ICDAS version, assessors/calibration, masking, photographs/examinations, inter-assessment agreement, missing assessments and arm differences are unverified.
Required materials and conditions
Original ICDAS criteria, assessors/masking, measurement conditions and reliability material
Materials to obtain first
Original ICDAS criteria, assessors/masking, measurement conditions and reliability material
Further research
Original methods/appendices linking actual readings, measurement limitations and results
Remaining uncertainty
ICDAS version, assessors/calibration, masking, photographs/examinations, inter-assessment agreement, missing assessments and arm differences are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the ICDAS assessment, masking and measurement reliability?" to the corresponding original record. ICDAS version, assessors/calibration, masking, photographs/examinations, inter-assessment agreement, missing assessments and arm differences are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the ICDAS assessment, masking and measurement reliability?
Application exceptions
ICDAS version, assessors/calibration, masking, photographs/examinations, inter-assessment agreement, missing assessments and arm differences are unverified. This gap is retained with the preservation scope, without new numbers, calculations or reassessment.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E03, C06

Related sources R01

N14 · Are patient, tooth and lesion units distinguished from repeated measurements?

Current findings
The original explanation identifies n as people and ICDAS as lesion scores. Multiple teeth/lesions and baseline/six-month values from the same person are not counted as independent participants.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
The required direct details were not verified within the current stored-summary and unread-external-material scope. ICDAS aggregation units, lesions per patient, selected teeth/surfaces, cluster/repeated-measure handling and denominators are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
ICDAS aggregation units, lesions per patient, selected teeth/surfaces, cluster/repeated-measure handling and denominators are unverified.
Required materials and conditions
Patient–tooth–lesion relationships, aggregation/models and unit-specific denominator/measurement tables
Materials to obtain first
Patient–tooth–lesion relationships, aggregation/models and unit-specific denominator/measurement tables
Further research
Material specifying original measurement units and within-patient correlation/repeated measurements
Remaining uncertainty
ICDAS aggregation units, lesions per patient, selected teeth/surfaces, cluster/repeated-measure handling and denominators are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "Are patient, tooth and lesion units distinguished from repeated measurements?" to the corresponding original record. ICDAS aggregation units, lesions per patient, selected teeth/surfaces, cluster/repeated-measure handling and denominators are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: Are patient, tooth and lesion units distinguished from repeated measurements?
Application exceptions
Do not transfer 91 patients or 52/39 participants to lesion/tooth denominators, or add repeated measurements/lesion counts as independent samples.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C02, C06, C07, E04

Related sources R01

N15 · What are six-month ICDAS, nominal exposure and assessment timing?

Current findings
The original records six-month ICDAS and six-month retainer/mousse exposure. Individual actual use duration, assessment windows and intermediate measurements are separate matters.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Orthodontic completion/baseline, final assessment timing, allowed windows, intermediate times, data cutoff and actual exposure/safety follow-up are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Orthodontic completion/baseline, final assessment timing, allowed windows, intermediate times, data cutoff and actual exposure/safety follow-up are unverified.
Required materials and conditions
Original schedules, baseline/six months, actual exposure/assessment and missing-data material
Materials to obtain first
Original schedules, baseline/six months, actual exposure/assessment and missing-data material
Further research
Same-trial material linking assessment windows/exposure and time-specific outcomes
Remaining uncertainty
Orthodontic completion/baseline, final assessment timing, allowed windows, intermediate times, data cutoff and actual exposure/safety follow-up are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are six-month ICDAS, nominal exposure and assessment timing?" to the corresponding original record. Orthodontic completion/baseline, final assessment timing, allowed windows, intermediate times, data cutoff and actual exposure/safety follow-up are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are six-month ICDAS, nominal exposure and assessment timing?
Application exceptions
Do not present six months as identical actual exposure/complete follow-up for every patient or invent intermediate effects absent from original material.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C06, E03, E08

Related sources R01

N16 · What is the original direction of baseline and six-month final values?

Current findings
The existing Korean verdict rationale records mousse 1.80→1.00 points and control 1.92→1.53 points. The original explanation that higher is worse and reduction indicates improvement is retained.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Details of each value's mean/median, dispersion/CI, aggregation/measurement unit, adjustment and original timing are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Details of each value's mean/median, dispersion/CI, aggregation/measurement unit, adjustment and original timing are unverified.
Required materials and conditions
Original baseline/final tables, aggregation/dispersion, units/denominators and models
Materials to obtain first
Original baseline/final tables, aggregation/dispersion, units/denominators and models
Further research
The same report providing original final/baseline values, dispersion and outcome units
Remaining uncertainty
Details of each value's mean/median, dispersion/CI, aggregation/measurement unit, adjustment and original timing are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is the original direction of baseline and six-month final values?" to the corresponding original record. Details of each value's mean/median, dispersion/CI, aggregation/measurement unit, adjustment and original timing are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is the original direction of baseline and six-month final values?
Application exceptions
Do not newly subtract baseline/final values or infer their dispersion/CIs or original control conditions.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C06, E04, E05

Related sources R01

N17 · What do changes of 0.80 versus 0.39 points represent?

Current findings
The original ICDAS reductions are 0.80 versus 0.39 points. Positively expressed reductions are recorded alongside the lower-is-better direction of final ICDAS values.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Details of sign/aggregation, change dispersion, paired measurements/adjustment and within-arm versus between-arm tests are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Details of sign/aggregation, change dispersion, paired measurements/adjustment and within-arm versus between-arm tests are unverified.
Required materials and conditions
Original change definitions, sign/units, dispersion, analysis methods and tables
Materials to obtain first
Original change definitions, sign/units, dispersion, analysis methods and tables
Further research
Material reporting changes/final values and distinguishing within-arm/between-arm results
Remaining uncertainty
Details of sign/aggregation, change dispersion, paired measurements/adjustment and within-arm versus between-arm tests are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What do changes of 0.80 versus 0.39 points represent?" to the corresponding original record. Details of sign/aggregation, change dispersion, paired measurements/adjustment and within-arm versus between-arm tests are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What do changes of 0.80 versus 0.39 points represent?
Application exceptions
Do not turn reductions of 0.80/0.39 into ICDAS increases or individual amounts of healing, or calculate new relative changes/effects.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C06, E04, E05

Related sources R01

N18 · What is the level of the original 0.41-point difference in change?

Current findings
The existing Korean verdict rationale records a 0.41-point difference in change. This existing original value is preserved; its model, CI and importance remain separate matters.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Adjustment, dispersion/CI, aggregation/clustering/repeated measurements and clinical-importance criteria are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Adjustment, dispersion/CI, aggregation/clustering/repeated measurements and clinical-importance criteria are unverified.
Required materials and conditions
Original between-arm change differences, models/units and CI/criterion tables
Materials to obtain first
Original between-arm change differences, models/units and CI/criterion tables
Further research
Material reporting definitions/intervals and importance of original between-arm outcomes
Remaining uncertainty
Adjustment, dispersion/CI, aggregation/clustering/repeated measurements and clinical-importance criteria are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is the level of the original 0.41-point difference in change?" to the corresponding original record. Adjustment, dispersion/CI, aggregation/clustering/repeated measurements and clinical-importance criteria are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is the level of the original 0.41-point difference in change?
Application exceptions
Use 0.41 points only as the original value; do not derive final-value differences, change ratios or new CIs.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E04, E05, C06

Related sources R01

N19 · What are between-arm P=0.003 and the effect interval?

Current findings
The evidence list records between-arm P=0.003 and the existing English text records P=.003. These are retained alongside the original direction of ICDAS changes; P is distinguished from effect size/intervals.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Original tests/models, CIs, dispersion, multiplicity, measurement/analysis units and importance are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Original tests/models, CIs, dispersion, multiplicity, measurement/analysis units and importance are unverified.
Required materials and conditions
Original statistical methods, test targets, effects/CIs and unit material
Materials to obtain first
Original statistical methods, test targets, effects/CIs and unit material
Further research
Original result tables linking actual models/intervals and testing objectives
Remaining uncertainty
Original tests/models, CIs, dispersion, multiplicity, measurement/analysis units and importance are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are between-arm P=0.003 and the effect interval?" to the corresponding original record. Original tests/models, CIs, dispersion, multiplicity, measurement/analysis units and importance are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are between-arm P=0.003 and the effect interval?
Application exceptions
Do not newly infer guaranteed individual remineralization, reduced caries or all forms of importance/clinical superiority from P=.003 alone.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E05, E04

Related sources R01

N20 · What are score aggregation, models and within-arm/between-arm analyses?

Current findings
The original records ICDAS baseline/final values, changes and between-arm P. The summary does not explain models for score means, categories/stages or patient/lesion aggregation.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
The required direct details were not verified within the current stored-summary and unread-external-material scope. Scale treatment, aggregation, baseline adjustment, clustering/repeated measurements, analysis assumptions, sensitivity and change dispersion are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Scale treatment, aggregation, baseline adjustment, clustering/repeated measurements, analysis assumptions, sensitivity and change dispersion are unverified.
Required materials and conditions
Original score aggregation/statistical methods, SAP, models/units and tables
Materials to obtain first
Original score aggregation/statistical methods, SAP, models/units and tables
Further research
Material specifying original ICDAS analysis with units, models and assumptions
Remaining uncertainty
Scale treatment, aggregation, baseline adjustment, clustering/repeated measurements, analysis assumptions, sensitivity and change dispersion are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are score aggregation, models and within-arm/between-arm analyses?" to the corresponding original record. Scale treatment, aggregation, baseline adjustment, clustering/repeated measurements, analysis assumptions, sensitivity and change dispersion are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are score aggregation, models and within-arm/between-arm analyses?
Application exceptions
Do not arbitrarily declare scores interval-scaled/normally distributed or models, adjustment or clustering not applicable.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E04, C06

Related sources R01

N21 · How do completer effects differ from effects in the full randomized population?

Current findings
The original main result is a 91/106 completer analysis; the parent verdict historically described this defect as avoidable through ITT/missing-data handling. Actual ITT results were not provided.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Allocation/adherence effects, completion selection, arm-specific exclusions and original ITT/sensitivity outcomes are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Allocation/adherence effects, completion selection, arm-specific exclusions and original ITT/sensitivity outcomes are unverified.
Required materials and conditions
Original analysis populations, completion/exclusions, missing-data assumptions and alternative analyses
Materials to obtain first
Original analysis populations, completion/exclusions, missing-data assumptions and alternative analyses
Further research
Material reporting randomized/completer populations and the actual scope of missing data
Remaining uncertainty
Allocation/adherence effects, completion selection, arm-specific exclusions and original ITT/sensitivity outcomes are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "How do completer effects differ from effects in the full randomized population?" to the corresponding original record. Allocation/adherence effects, completion selection, arm-specific exclusions and original ITT/sensitivity outcomes are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: How do completer effects differ from effects in the full randomized population?
Application exceptions
Do not turn completer analysis into full-population ITT or create new ITT values/bias magnitudes from the parent's explanation of avoidability.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E04, C07

Related sources R01

N22 · What are the reported intervals and criteria for an important ICDAS difference?

Current findings
Original changes/differences and P are retained. Although ICDAS is lower-is-better, the summary lacks justified important-difference/patient-utility criteria and CIs.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
The required direct details were not verified within the current stored-summary and unread-external-material scope. Minimum important differences, stage/lesion-recovery criteria, intervals/dispersion and power/original plans are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Minimum important differences, stage/lesion-recovery criteria, intervals/dispersion and power/original plans are unverified.
Required materials and conditions
Original importance/clinical-linkage criteria, effect intervals and planning assumptions
Materials to obtain first
Original importance/clinical-linkage criteria, effect intervals and planning assumptions
Further research
If justified original criteria are provided, link them with score differences/intervals
Remaining uncertainty
Minimum important differences, stage/lesion-recovery criteria, intervals/dispersion and power/original plans are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the reported intervals and criteria for an important ICDAS difference?" to the corresponding original record. Minimum important differences, stage/lesion-recovery criteria, intervals/dispersion and power/original plans are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the reported intervals and criteria for an important ICDAS difference?
Application exceptions
Do not automatically use 0.41 points, statistical positivity or parent C50 as criteria establishing patient-important effects.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E05, E09

Related sources R01

N23 · What do registration 'Not confirmed', prespecification and plans mean?

Current findings
The existing registration identifier record is the string 'Not confirmed'. The current registration ID remains null; this original record and unverified scope are retained.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Registration/protocol/SAP, original primary/secondary outcomes, analyses/times and change history are externally unread. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Registration/protocol/SAP, original primary/secondary outcomes, analyses/times and change history are externally unread.
Required materials and conditions
Original registration/plans, endpoints/times, analysis versions and change material
Materials to obtain first
Original registration/plans, endpoints/times, analysis versions and change material
Further research
If actual plans are provided, distinguish original unverified status from new additional events/comparison scope
Remaining uncertainty
Registration/protocol/SAP, original primary/secondary outcomes, analyses/times and change history are externally unread.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What do registration 'Not confirmed', prespecification and plans mean?" to the corresponding original record. Registration/protocol/SAP, original primary/secondary outcomes, analyses/times and change history are externally unread.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What do registration 'Not confirmed', prespecification and plans mean?
Application exceptions
Do not convert 'Not confirmed' into unregistered/no registration, access failure or confirmed selective reporting.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E06, C09

Related sources R01

N24 · What is the scope of multiplicity and disclosure of all outcomes/times?

Current findings
The original material contains six-month ICDAS, adverse-effect reporting and unmeasured caries context. It does not provide a complete primary/secondary endpoint, time or analysis list.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
The required direct details were not verified within the current stored-summary and unread-external-material scope. Full outcome lists, multiplicity adjustment, exploratory/confirmatory status, prespecified analyses/changes and unpublished outcomes are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Full outcome lists, multiplicity adjustment, exploratory/confirmatory status, prespecified analyses/changes and unpublished outcomes are unverified.
Required materials and conditions
Protocol/SAP, all outcomes/times and reporting/change tables
Materials to obtain first
Protocol/SAP, all outcomes/times and reporting/change tables
Further research
Material linking original plans and reports by outcome
Remaining uncertainty
Full outcome lists, multiplicity adjustment, exploratory/confirmatory status, prespecified analyses/changes and unpublished outcomes are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is the scope of multiplicity and disclosure of all outcomes/times?" to the corresponding original record. Full outcome lists, multiplicity adjustment, exploratory/confirmatory status, prespecified analyses/changes and unpublished outcomes are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is the scope of multiplicity and disclosure of all outcomes/times?
Application exceptions
Do not certify that all endpoints/times match plans or that selective reporting is absent from P=.003 and a single report.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E06, C08

Related sources R01

N25 · What are the original verdict and unmeasured scope for sibling caries prevention?

Current findings
The caries-prevention sheet concerns 'Prevention of incident caries', with grade '?' and the note 'Not measured'. The parent verdict states that reduced new caries/filling treatment was not measured.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Original clinical-event definitions/collection, long-term outcomes, registration plans and current related material were not verified in this work. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Original clinical-event definitions/collection, long-term outcomes, registration plans and current related material were not verified in this work.
Required materials and conditions
The same trial's outcome list and direct clinical-event material for the prevention question
Materials to obtain first
The same trial's outcome list and direct clinical-event material for the prevention question
Further research
If direct event material is provided, distinguish connections for remineralization from separate questions/scopes
Remaining uncertainty
Original clinical-event definitions/collection, long-term outcomes, registration plans and current related material were not verified in this work.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the original verdict and unmeasured scope for sibling caries prevention?" to the corresponding original record. Original clinical-event definitions/collection, long-term outcomes, registration plans and current related material were not verified in this work.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the original verdict and unmeasured scope for sibling caries prevention?
Application exceptions
Do not turn the sibling '?' into D or upgrade the original unmeasured description to zero prevention studies worldwide, zero effect or current full-text verification.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E09, C08

Related sources R01

N26 · Does ICDAS remineralization also answer questions about new caries, fillings or tooth loss?

Current findings
The selected outcome is a lesion-score surrogate. The existing core explanation/counterview states that improved scores cannot be transferred to reduced caries incidence or filling treatment.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Direct clinical-event effects, units/denominators, duration, surrogate prediction/mediation and long-term material are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Direct clinical-event effects, units/denominators, duration, surrogate prediction/mediation and long-term material are unverified.
Required materials and conditions
Direct definitions, denominators and durations for new caries/treatment and tooth outcomes, with related validation
Materials to obtain first
Direct definitions, denominators and durations for new caries/treatment and tooth outcomes, with related validation
Further research
If appropriate direct event material is provided, link scores and clinical outcomes separately
Remaining uncertainty
Direct clinical-event effects, units/denominators, duration, surrogate prediction/mediation and long-term material are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "Does ICDAS remineralization also answer questions about new caries, fillings or tooth loss?" to the corresponding original record. Direct clinical-event effects, units/denominators, duration, surrogate prediction/mediation and long-term material are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: Does ICDAS remineralization also answer questions about new caries, fillings or tooth loss?
Application exceptions
Do not extend positive remineralization/lesion scores to established caries prevention, avoidance of filling treatment or all dental-health benefits.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E09, E08

Related sources R01

N27 · Are visual improvement and benefits in patient appearance/daily life the same?

Current findings
The existing counterview states that visual/score-based remineralization may be useful to patients. It does not provide direct patient satisfaction, appearance/pain or quality-of-life values.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
The required direct details were not verified within the current stored-summary and unread-external-material scope. Patient-reported appearance/satisfaction, daily life/quality of life, symptoms, persistence, importance and denominators are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Patient-reported appearance/satisfaction, daily life/quality of life, symptoms, persistence, importance and denominators are unverified.
Required materials and conditions
Patient-centered outcomes/scales, definitions, denominators/times and original results
Materials to obtain first
Patient-centered outcomes/scales, definitions, denominators/times and original results
Further research
If material directly reporting patient-centered outcomes is provided, distinguish it from lesion scores
Remaining uncertainty
Patient-reported appearance/satisfaction, daily life/quality of life, symptoms, persistence, importance and denominators are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "Are visual improvement and benefits in patient appearance/daily life the same?" to the corresponding original record. Patient-reported appearance/satisfaction, daily life/quality of life, symptoms, persistence, importance and denominators are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: Are visual improvement and benefits in patient appearance/daily life the same?
Application exceptions
Do not turn the original possibility of usefulness into verified patient satisfaction, daily-life improvement or cosmetic effects.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E09, E08

Related sources R01

N28 · What are the concurrent or alternative effects of hygiene, fluoride, diet and retainers?

Current findings
The original comparison concerns lesion-score changes with F-ACP mousse/Essix. The summary lacks actual balance in basic oral care, other products/diet and natural recovery.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
The required direct details were not verified within the current stored-summary and unread-external-material scope. Arm-specific concurrent fluoride/toothpaste, diet/hygiene, retainers, natural course, intervention/assessment differences and handling methods are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Arm-specific concurrent fluoride/toothpaste, diet/hygiene, retainers, natural course, intervention/assessment differences and handling methods are unverified.
Required materials and conditions
Control/concurrent treatment, actual behavior/adherence and original baseline/analysis material
Materials to obtain first
Control/concurrent treatment, actual behavior/adherence and original baseline/analysis material
Further research
Material linking common/different exposures and the original effect of interest in the same randomized comparison
Remaining uncertainty
Arm-specific concurrent fluoride/toothpaste, diet/hygiene, retainers, natural course, intervention/assessment differences and handling methods are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the concurrent or alternative effects of hygiene, fluoride, diet and retainers?" to the corresponding original record. Arm-specific concurrent fluoride/toothpaste, diet/hygiene, retainers, natural course, intervention/assessment differences and handling methods are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the concurrent or alternative effects of hygiene, fluoride, diet and retainers?
Application exceptions
Do not declare all care identical or other causes absent from missing information, or generate oral-care instructions for users.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E02, H05

Related sources R01

N29 · What are actual adherence, discontinuations and duration/dose comparisons?

Current findings
Six-month mousse exposure inside Essix is a nominal research condition. Actual individual adherence, dose reduction/discontinuation and direct comparisons of other durations/products are not separately provided.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Adherence measurement/distribution, discontinuations/changes, actual contact/amount and direct frequency/duration/formulation comparisons are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Adherence measurement/distribution, discontinuations/changes, actual contact/amount and direct frequency/duration/formulation comparisons are unverified.
Required materials and conditions
Original adherence/changes, exposure and direct-comparison/SAP material
Materials to obtain first
Original adherence/changes, exposure and direct-comparison/SAP material
Further research
Material distinguishing direct exposure-specific outcomes in the same or appropriate additional research
Remaining uncertainty
Adherence measurement/distribution, discontinuations/changes, actual contact/amount and direct frequency/duration/formulation comparisons are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are actual adherence, discontinuations and duration/dose comparisons?" to the corresponding original record. Adherence measurement/distribution, discontinuations/changes, actual contact/amount and direct frequency/duration/formulation comparisons are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are actual adherence, discontinuations and duration/dose comparisons?
Application exceptions
Do not turn nominal six-month exposure into optimal duration/frequency, retainer-care or product-use recommendations.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E02, E08

Related sources R01

N30 · What direct material addresses other populations, subgroups and long-term maintenance?

Current findings
The original is a six-month lesion-surrogate trial in post-orthodontic white spots. Other ages/lesion risks, during-orthodontic/non-orthodontic settings and persistence after stopping are separate questions.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
The required direct details were not verified within the current stored-summary and unread-external-material scope. Prespecified subgroups/interactions, direct population/product comparisons, longer follow-up and persistence after stopping are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Prespecified subgroups/interactions, direct population/product comparisons, longer follow-up and persistence after stopping are unverified.
Required materials and conditions
Extended populations/exposures, prespecified subgroups and duration-specific direct outcomes
Materials to obtain first
Extended populations/exposures, prespecified subgroups and duration-specific direct outcomes
Further research
If additional material is provided, specify differences from original populations, exposures and times in the connection
Remaining uncertainty
Prespecified subgroups/interactions, direct population/product comparisons, longer follow-up and persistence after stopping are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What direct material addresses other populations, subgroups and long-term maintenance?" to the corresponding original record. Prespecified subgroups/interactions, direct population/product comparisons, longer follow-up and persistence after stopping are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What direct material addresses other populations, subgroups and long-term maintenance?
Application exceptions
Prespecified subgroups/interactions, direct population/product comparisons, longer follow-up and persistence after stopping are unverified. This gap is retained with the preservation scope, without new numbers, calculations or reassessment.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E08, E07

Related sources R01

N31 · Do single-trial/R1/I1 history and current independent replication differ?

Current findings
The parent records a small single trial and R1/I1 in the original verdict. The 1 evidence/citation slot, patients/teeth/lesions and two siblings are not current independent replications.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Current additional/follow-up reports, direct replication in other populations/products and material-family/independence relationships were not newly searched. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Current additional/follow-up reports, direct replication in other populations/products and material-family/independence relationships were not newly searched.
Required materials and conditions
Report/trial/population, product/source and outcome relationships, with direct independent material
Materials to obtain first
Report/trial/population, product/source and outcome relationships, with direct independent material
Further research
If material is provided, list same/separate/unclear populations and distinguish verification levels
Remaining uncertainty
Current additional/follow-up reports, direct replication in other populations/products and material-family/independence relationships were not newly searched.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "Do single-trial/R1/I1 history and current independent replication differ?" to the corresponding original record. Current additional/follow-up reports, direct replication in other populations/products and material-family/independence relationships were not newly searched.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: Do single-trial/R1/I1 history and current independent replication differ?
Application exceptions
Do not inherit a single trial/R1 and historical I1 as current worldwide trial counts or passed independence, or count outcomes/times as independent replications.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C02, E07, C10, H07

Related sources R01

N32 · What history is represented by the original small-study/completer and duration defect descriptions?

Current findings
The parent verdict records two listed defects: fewer than 200 participants and completer analysis. It explains that six months was not counted because it was not shorter than 12 weeks. This is parent-score/verdict history.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. These case-specific conditions did not automatically adopt the original 200 participants/12 weeks as minimum criteria or reassess them as new defect scores. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
These case-specific conditions did not automatically adopt the original 200 participants/12 weeks as minimum criteria or reassess them as new defect scores.
Required materials and conditions
Complete parent-verdict history and actual design/analysis material
Materials to obtain first
Complete parent-verdict history and actual design/analysis material
Further research
If corrections/method changes are provided, preserve original history separately from new events
Remaining uncertainty
These case-specific conditions did not automatically adopt the original 200 participants/12 weeks as minimum criteria or reassess them as new defect scores.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What history is represented by the original small-study/completer and duration defect descriptions?" to the corresponding original record. These case-specific conditions did not automatically adopt the original 200 participants/12 weeks as minimum criteria or reassess them as new defect scores.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What history is represented by the original small-study/completer and duration defect descriptions?
Application exceptions
Do not copy parent checklist criteria as universal participant/duration rules for new conditions, current completed review or reassessment.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C09, E04, E05

Related sources R01

N33 · What is the scope of no patient/guardian-reported adverse effects over six months?

Current findings
The existing safety description states that patients or guardians reported no adverse effects over six months. The original parent Good safety status is preserved separately from this reporting scope.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Event definitions, systematic/spontaneous collection, grades/discontinuations, original safety denominators and actual records/verification are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Event definitions, systematic/spontaneous collection, grades/discontinuations, original safety denominators and actual records/verification are unverified.
Required materials and conditions
Original adverse-effect reporting/collection, population/duration and definition/discontinuation material
Materials to obtain first
Original adverse-effect reporting/collection, population/duration and definition/discontinuation material
Further research
Original material specifying reporting methods and the actual safety scope for the same exposure
Remaining uncertainty
Event definitions, systematic/spontaneous collection, grades/discontinuations, original safety denominators and actual records/verification are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is the scope of no patient/guardian-reported adverse effects over six months?" to the corresponding original record. Event definitions, systematic/spontaneous collection, grades/discontinuations, original safety denominators and actual records/verification are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is the scope of no patient/guardian-reported adverse effects over six months?
Application exceptions
Do not extend a no-reports sentence to zero events of all kinds, complete collection, individual harmlessness or long-term safety certification.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E10, H01, H09

Related sources R01

N34 · What are the adverse-effect denominators, dropout and reporting selection?

Current findings
The original 91/106 completers and 52/39 participants form the efficacy-analysis population. The summary does not distinguish whether patient/guardian adverse-effect reporting covered all randomized participants, completers or those actually exposed.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
The required direct details were not verified within the current stored-summary and unread-external-material scope. Safety populations, reporting/exposure/follow-up, events among dropouts, missing reports/recall and arm-specific detection differences are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Safety populations, reporting/exposure/follow-up, events among dropouts, missing reports/recall and arm-specific detection differences are unverified.
Required materials and conditions
Original safety-population/exposure, collection/missing reports and dropout/follow-up tables
Materials to obtain first
Original safety-population/exposure, collection/missing reports and dropout/follow-up tables
Further research
Safety material specifying denominators and reporting/follow-up selection
Remaining uncertainty
Safety populations, reporting/exposure/follow-up, events among dropouts, missing reports/recall and arm-specific detection differences are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the adverse-effect denominators, dropout and reporting selection?" to the corresponding original record. Safety populations, reporting/exposure/follow-up, events among dropouts, missing reports/recall and arm-specific detection differences are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the adverse-effect denominators, dropout and reporting selection?
Application exceptions
Do not fill verified safety denominators with the 91 efficacy participants or 106 randomized participants, or calculate new incidence/intervals from no reports.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions H04, H06, C07

Related sources R01

N35 · What are harm occurrence, discontinuation and exposure/follow-up times?

Current findings
The original safety-reporting window is six months. Actual mousse/retainer exposure, onset/recovery, discontinuation/reuse and subsequent observation require separate material.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
The required direct details were not verified within the current stored-summary and unread-external-material scope. Event chronology, actual contact duration, discontinuation/re-exposure, collection windows/original cutoff and loss to follow-up are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Event chronology, actual contact duration, discontinuation/re-exposure, collection windows/original cutoff and loss to follow-up are unverified.
Required materials and conditions
Original exposure/events, collection/discontinuation/recovery and timing material
Materials to obtain first
Original exposure/events, collection/discontinuation/recovery and timing material
Further research
Original material specifying actual time and safety follow-up for the same exposure
Remaining uncertainty
Event chronology, actual contact duration, discontinuation/re-exposure, collection windows/original cutoff and loss to follow-up are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are harm occurrence, discontinuation and exposure/follow-up times?" to the corresponding original record. Event chronology, actual contact duration, discontinuation/re-exposure, collection windows/original cutoff and loss to follow-up are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are harm occurrence, discontinuation and exposure/follow-up times?
Application exceptions
Do not transfer nominal six-month exposure/reporting to complete individual harm observation or future safety.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions H02, H04

Related sources R01

N36 · What are the harm or alternative causes involving ingredients, retainers and baseline conditions?

Current findings
The original exposure concerns fluoride/carbonate-containing F-ACP and Essix. The summary lacks contributions from other ingredients/retainers, baseline oral conditions/exposures and possible events.
Verification status
Unverified
Materials actually read
Summary read; external materials not read
Why unverified
The required direct details were not verified within the current stored-summary and unread-external-material scope. Additives, baseline/concurrent conditions, other products, actual exposure, attribution/alternatives, vulnerable populations/long-term and rare harms are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Additives, baseline/concurrent conditions, other products, actual exposure, attribution/alternatives, vulnerable populations/long-term and rare harms are unverified.
Required materials and conditions
Original ingredients/products, baseline/concurrent conditions, event attribution and long-term/population-specific safety
Materials to obtain first
Original ingredients/products, baseline/concurrent conditions, event attribution and long-term/population-specific safety
Further research
If appropriate direct safety material is provided, distinguish differences from the original exposure/reporting scope
Remaining uncertainty
Additives, baseline/concurrent conditions, other products, actual exposure, attribution/alternatives, vulnerable populations/long-term and rare harms are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the harm or alternative causes involving ingredients, retainers and baseline conditions?" to the corresponding original record. Additives, baseline/concurrent conditions, other products, actual exposure, attribution/alternatives, vulnerable populations/long-term and rare harms are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the harm or alternative causes involving ingredients, retainers and baseline conditions?
Application exceptions
Do not exclude all events such as allergy/ingredient harms or generate product-suitability/use recommendations from no reports alone.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions H05, H08, E10

Related sources R01

N37 · What is the original funding statement about no external funding?

Current findings
The original evidence-list funding phrase 'This research received no external funding' and the Korean/English funding-check descriptions are retained. Original checked scope is distinguished from current reading.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Original contracts, institutional/internal funding, sponsor/author roles, complete COI and data access are externally unread. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Original contracts, institutional/internal funding, sponsor/author roles, complete COI and data access are externally unread.
Required materials and conditions
Original funding/resources, design/collection/analysis/publication roles and COI material
Materials to obtain first
Original funding/resources, design/collection/analysis/publication roles and COI material
Further research
If actual original declarations are provided, record checked levels/locations separately from unverified scope
Remaining uncertainty
Original contracts, institutional/internal funding, sponsor/author roles, complete COI and data access are externally unread.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What is the original funding statement about no external funding?" to the corresponding original record. Original contracts, institutional/internal funding, sponsor/author roles, complete COI and data access are externally unread.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What is the original funding statement about no external funding?
Application exceptions
Do not certify absence of all funding/product/company involvement or COI, or completed current independence from the no-external-funding quotation.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C10

Related sources R01

N38 · Does unverified product-provision wording differ from actual absence of provision?

Current findings
The original records that trial-product provision wording was not identified in the publicly checked COI/acknowledgments. Parent I1 represents that historical checked scope.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Complete product supply/in-kind support, author employment/patents, COI/acknowledgments, contracts and current changes are unverified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Complete product supply/in-kind support, author employment/patents, COI/acknowledgments, contracts and current changes are unverified.
Required materials and conditions
Original product-provision/contracts, COI/acknowledgments and role declarations
Materials to obtain first
Original product-provision/contracts, COI/acknowledgments and role declarations
Further research
If original documents are provided, distinguish unverified/unreported status from the actual scope of provision/absence
Remaining uncertainty
Complete product supply/in-kind support, author employment/patents, COI/acknowledgments, contracts and current changes are unverified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "Does unverified product-provision wording differ from actual absence of provision?" to the corresponding original record. Complete product supply/in-kind support, author employment/patents, COI/acknowledgments, contracts and current changes are unverified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: Does unverified product-provision wording differ from actual absence of provision?
Application exceptions
Do not convert unconfirmed wording into no product provision, external access failure or current independence certification.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C10, C09

Related sources R01

N39 · What are the Korean/English texts, parent axes, false/null values and verdict history?

Current findings
The parent C50/Good status, axes B/S/R1/I1/E+/B2, unrecorded precision, false coprimary-split/large hard-endpoint RCT/no-human-study flags and empty override reasons are preserved as originally recorded. Korean/English texts, synthesis, grade decisions and cross-checking are historical context.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Original values/axes and historical checks were not inherited as current subclaim scores, condition fulfillment or completed review. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Original values/axes and historical checks were not inherited as current subclaim scores, condition fulfillment or completed review.
Required materials and conditions
Separate preservation of subclaim/parent, original languages/axes/empty values and verdict history
Materials to obtain first
Separate preservation of subclaim/parent, original languages/axes/empty values and verdict history
Further research
If actual corrections are provided, distinguish complete original text, events/versions and decisions by scope
Remaining uncertainty
Original values/axes and historical checks were not inherited as current subclaim scores, condition fulfillment or completed review.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the Korean/English texts, parent axes, false/null values and verdict history?" to the corresponding original record. Original values/axes and historical checks were not inherited as current subclaim scores, condition fulfillment or completed review.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the Korean/English texts, parent axes, false/null values and verdict history?
Application exceptions
Do not fill unrecorded precision with 0 or declare parent B2, historical checking/cross-checking as newly completed model review or subclaim scores.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C01, C09, E06

Related sources R01

N40 · Do the reference date, corrections/empty values differ from production dates/scope?

Current findings
The original reference date 2026-08-26, empty corrections/deliberation and the 2024 bibliography/unverified registration record are preserved. Current time belongs to a production event.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Evidence reference-date/classification records are absent, and no registration/correction/retraction, new search/material or link comparison was performed. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Evidence reference-date/classification records are absent, and no registration/correction/retraction, new search/material or link comparison was performed.
Required materials and conditions
Original publication/search/registration/correction versions and current production events
Materials to obtain first
Original publication/search/registration/correction versions and current production events
Further research
If material/corrections are actually provided, distinguish original scope, complete before/after text and new events
Remaining uncertainty
Evidence reference-date/classification records are absent, and no registration/correction/retraction, new search/material or link comparison was performed.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "Do the reference date, corrections/empty values differ from production dates/scope?" to the corresponding original record. Evidence reference-date/classification records are absent, and no registration/correction/retraction, new search/material or link comparison was performed.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: Do the reference date, corrections/empty values differ from production dates/scope?
Application exceptions
Do not borrow empty corrections/the original reference date as current absence of corrections or this work's review date, or label no search as zero studies.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C09, C03

Related sources R01

N41 · What are the boundaries between score benefits/reported harms and current applicability/product selection?

Current findings
This sheet records ICDAS remineralization for the specified existing question and gaps in denominators/exposure, surrogates, safety and sponsorship in the same report. Individual dental products/use, treatment selection and current suitability are separate matters.
Verification status
Partly verified
Materials actually read
Summary read; external materials not read
Why unverified
Some information from the stored summary was linked for production. Current products/guidelines, individual oral status, other compositions/controls and direct material on current benefit/harm applicability were not verified. Review of the existing content is incomplete; this does not certify fulfillment of clinical conditions, zero effect or absence of material.
Reason for missing information
Current products/guidelines, individual oral status, other compositions/controls and direct material on current benefit/harm applicability were not verified.
Required materials and conditions
Direct material for extended populations/exposures, clinical events/patient outcomes and harms, with applicability differences
Materials to obtain first
Direct material for extended populations/exposures, clinical events/patient outcomes and harms, with applicability differences
Further research
If material is provided and the scope allows, update research gaps while distinguishing the original sheet from other applicability questions
Remaining uncertainty
Current products/guidelines, individual oral status, other compositions/controls and direct material on current benefit/harm applicability were not verified.
Conditions for verification
Link the original values, definitions, units, denominators, timing, checked scope and unverified details for "What are the boundaries between score benefits/reported harms and current applicability/product selection?" to the corresponding original record. Current products/guidelines, individual oral status, other compositions/controls and direct material on current benefit/harm applicability were not verified.
Why this condition is needed
Needed to record the scope of the selected ICDAS remineralization question separately: What are the boundaries between score benefits/reported harms and current applicability/product selection?
Application exceptions
Do not extend C/positive scores, the original Good status or no reported adverse effects to caries prevention/daily-life benefits, individual safety/suitability or product-use/selection/administration recommendations.
Referenced methods
Chamgap's question-specific condition referring to the relevant stored summary record and family definitions H09, E09, E08, C09

Related sources R01