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

Verdict 2926 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-10

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- 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

## Checklist items

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

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: The original candidate-boundary review wait is historical information; no model content/boundary review was performed in this work.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: There are no direct values for the selected subclaim score, status or axes.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Follow-up/other report versions, overlapping populations, lesion/tooth relationships and current unique trial/participant totals are unresolved.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: External public availability/acquisition, current content, access success and link operation were not verified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Age range, sex, baseline lesion/caries risk, orthodontic/retainer status, eligibility/exclusions and recruitment are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Teeth/surfaces, lesion counts, lesion criteria, photography/drying, orthodontic completion timing, assessment environment and baseline balance are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: The finished trial product/manufacturer, ingredient concentrations, other additives, batches, provision/quality and equivalence between products are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Application amount, frequency, retainer wear/cleaning, actual adherence, discontinuations/changes, contact time and route details are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Direct definitions of control-arm fluoride/toothpaste, retainers, placebo/no treatment, hygiene/diet and common/arm-specific care are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Randomized n by arm, selection/exposure/completion/assessment flow, tooth/lesion counts and original counts by exclusion reason are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original records 91/106, 14.2% dropout and completer analysis. Dropout rates, analysis inclusion and original observation/exposure are distinguished.
- 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
- 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.
- Remaining uncertainty: Arm-specific dropout/nonadherence, timing/reasons, dropout baseline/outcomes, missing-data handling and sensitivity are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: The summary lacks parallel/cluster/crossover design, random-sequence/allocation concealment, baseline balance and implementation-role details.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: ICDAS version, assessors/calibration, masking, photographs/examinations, inter-assessment agreement, missing assessments and arm differences are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: ICDAS aggregation units, lesions per patient, selected teeth/surfaces, cluster/repeated-measure handling and denominators are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Orthodontic completion/baseline, final assessment timing, allowed windows, intermediate times, data cutoff and actual exposure/safety follow-up are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Details of each value's mean/median, dispersion/CI, aggregation/measurement unit, adjustment and original timing are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Details of sign/aggregation, change dispersion, paired measurements/adjustment and within-arm versus between-arm tests are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Adjustment, dispersion/CI, aggregation/clustering/repeated measurements and clinical-importance criteria are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Original tests/models, CIs, dispersion, multiplicity, measurement/analysis units and importance are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Scale treatment, aggregation, baseline adjustment, clustering/repeated measurements, analysis assumptions, sensitivity and change dispersion are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Allocation/adherence effects, completion selection, arm-specific exclusions and original ITT/sensitivity outcomes are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Minimum important differences, stage/lesion-recovery criteria, intervals/dispersion and power/original plans are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Registration/protocol/SAP, original primary/secondary outcomes, analyses/times and change history are externally unread.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Full outcome lists, multiplicity adjustment, exploratory/confirmatory status, prespecified analyses/changes and unpublished outcomes are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Original clinical-event definitions/collection, long-term outcomes, registration plans and current related material were not verified in this work.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Direct clinical-event effects, units/denominators, duration, surrogate prediction/mediation and long-term material are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Patient-reported appearance/satisfaction, daily life/quality of life, symptoms, persistence, importance and denominators are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Arm-specific concurrent fluoride/toothpaste, diet/hygiene, retainers, natural course, intervention/assessment differences and handling methods are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Adherence measurement/distribution, discontinuations/changes, actual contact/amount and direct frequency/duration/formulation comparisons are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Prespecified subgroups/interactions, direct population/product comparisons, longer follow-up and persistence after stopping are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Current additional/follow-up reports, direct replication in other populations/products and material-family/independence relationships were not newly searched.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Event definitions, systematic/spontaneous collection, grades/discontinuations, original safety denominators and actual records/verification are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Safety populations, reporting/exposure/follow-up, events among dropouts, missing reports/recall and arm-specific detection differences are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: The original safety-reporting window is six months. Actual mousse/retainer exposure, onset/recovery, discontinuation/reuse and subsequent observation require separate material.
- 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
- 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.
- Remaining uncertainty: Event chronology, actual contact duration, discontinuation/re-exposure, collection windows/original cutoff and loss to follow-up are unverified.
- 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?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Additives, baseline/concurrent conditions, other products, actual exposure, attribution/alternatives, vulnerable populations/long-term and rare harms are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Original contracts, institutional/internal funding, sponsor/author roles, complete COI and data access are externally unread.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Complete product supply/in-kind support, author employment/patents, COI/acknowledgments, contracts and current changes are unverified.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Original values/axes and historical checks were not inherited as current subclaim scores, condition fulfillment or completed review.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Evidence reference-date/classification records are absent, and no registration/correction/retraction, new search/material or link comparison was performed.
- 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?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- 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.
- 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
- 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.
- Remaining uncertainty: Current products/guidelines, individual oral status, other compositions/controls and direct material on current benefit/harm applicability were not verified.
- Referenced methods: Chamgap's question-specific condition referring to the relevant stored summary record and family definitions H09, E09, E08, C09
- Related sources: R01

## Evidence and sources

### R01

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

[PubMed](https://pubmed.ncbi.nlm.nih.gov/38927409/)

Materials actually read: Summary read; external abstracts, full texts and registrations unread  
Findings recorded in the 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  
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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Complete original-byte copy of the stored summary | Stored summary copy acquired and summary read | Summary read | The complete parent/subclaims, original ICDAS values, denominators, sources/registration and safety history were read for production. This is not original-paper/registration reading. |
| External abstract | External material unread; no access attempts | Access not attempted; not obtained | Not read | Only the original PubMed bibliography URL is linked; no abstract acquisition/reading or link testing. |
| External full text | External material unread; no access attempts | Access not attempted; not obtained | Not read | The original URL establishes bibliographic identity, not certification of full-text access, acquisition or reading. |
| External registration | External material unread; no access attempts | Access not attempted; not obtained | Not read | The 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 protocol | Not acquired; detailed existence unverified | Access not attempted; not obtained | Not read | Original eligibility, control fluoride, ingredients/exposure, ICDAS reading/timing and primary/secondary/change plans are needed. |
| Required analysis plan | Not acquired; detailed existence unverified | Access not attempted; not obtained | Not read | Original material on patient/tooth/lesion units, aggregation/models, repeated measurements/clustering, missing data/denominators/CIs and importance is needed. |
| Required result tables and safety material | Not acquired; detailed existence unverified | Access not attempted; not obtained | Not read | Original final/change/between-arm tables, dispersion/CIs, dropout/exposure, safety-reporting populations/times and attribution are needed. |
| Required funding and interests | Not acquired; detailed existence unverified | Access not attempted; not obtained | Not read | No external funding/unverified product wording are historical records. Complete declarations, product provision, sponsor/author roles are externally unread. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 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.