{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "F-ACP dental mousse · White spots after orthodontic treatment · Six-month ICDAS remineralization evidence sheet",
  "language": "en",
  "translation_date": "2026-10-10",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    }
  ],
  "status_dictionary": {
    "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."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Which existing question and record are being presented in the sheet?",
      "needed": "Relationships among the original question, record and parent/sibling outcomes",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: Which existing question and record are being presented in the sheet?",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C01",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If additional material is provided, a linked outcome text retaining the original existing question and its connection"
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "How are the subclaim C/note, parent C50 and missing scores/axes distinguished?",
      "needed": "A separate record of original subclaim/parent verdicts, notes, scores/axes and missing values",
      "role": "Required",
      "role_reason": "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_exception": "Do not create a uniform D grade, inherit the parent's 50 points/axes, or create current condition fulfillment or a new verdict.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C01, C09",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If an actual verdict correction is provided, separate the complete original text, event/version and change decision"
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "What is shared among one report, lesions/patients and sibling questions?",
      "needed": "Relationship table for bibliography/trial families, patients/teeth/lesions and times/outcomes",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: What is shared among one report, lesions/patients and sibling questions?",
      "application_exception": "Do not count times, lesions/teeth, sibling sheets, the 106/91 participants or arm-specific participants as new participants or independent replications.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C02, E07, H07",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If additional reports are provided, distinguish relationships among the same populations/reports/outcomes and separate material"
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "What are the actual summary-reading and external original-material statuses?",
      "needed": "Stored summaries and external original-material existence/acquisition, reading level and original locations",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: What are the actual summary-reading and external original-material statuses?",
      "application_exception": "Do not upgrade summary reading to paper/registration reading or label no access attempt as access failure or absence of research.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C03",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "When further acquisition is allowed, record actual reading/attempts and dates separately"
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What is the scope of white spots after orthodontic treatment and the actual population?",
      "needed": "Original population eligibility/exclusions, baseline risk, age and orthodontic-status table",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C04, E08",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Same-trial material specifying the selected population and direct outcomes, or appropriate separate material"
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "What are the baseline lesion/tooth distribution and assessment conditions?",
      "needed": "Original lesion/tooth distribution, selection criteria and assessment-environment/baseline table",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: What are the baseline lesion/tooth distribution and assessment conditions?",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C04, E03, C06",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Original material linking patient/lesion baseline status to measurement conditions"
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What are the original F-ACP ingredients and the other CPP-ACP product families?",
      "needed": "Trial-product identity, composition/concentration and original product/provision information",
      "role": "Required",
      "role_reason": "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_exception": "Do not equate F-ACP with CPP-ACP or all fluoride products, or convert product-family marketing into clinical-event evidence for this trial.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C05, E08",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Material specifying applicability differences between the actual trial product and other compositions/products"
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "What is the scope of six-month research exposure inside an Essix retainer?",
      "needed": "Original product/retainer exposure, nominal/actual use and adherence/change material",
      "role": "Required",
      "role_reason": "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_exception": "Do not turn the original research exposure into product-use instructions, retainer care, dose/frequency conversions or individual treatment guidance.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C05, E02, E08",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Original implementation material linking actual exposure and outcomes in the same study"
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Were the control arm's fluoride and basic treatment conditions directly reported?",
      "needed": "Original control treatment, product/concentration, common/arm-specific care and actual implementation",
      "role": "Required",
      "role_reason": "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_exception": "Do not generate fluoride-control ingredients/concentrations, placebo/no-treatment definitions or use frequency absent from the existing review summary.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C05, E02",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Protocol/report specifying the actual control and concurrent conditions in the same trial"
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What are the denominators for 106 randomized, 91 completers and 52/39 participants?",
      "needed": "Allocation → exposure → completion/assessment → analysis, and patient/lesion denominator tables",
      "role": "Required",
      "role_reason": "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_exception": "Do not infer arm allocation from 106 participants or convert 52/39 into tooth/lesion counts.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C07, E04",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Same-trial material linking arm-specific flow to original denominators for each unit"
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What is the scope of the original 14.2% dropout and completer selection?",
      "needed": "Original dropout/exclusion, follow-up, baseline/missing-data handling and analysis flow",
      "role": "Required",
      "role_reason": "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_exception": "Do not calculate new dropout counts from 106−91 or copy the original 14.2% as each arm's dropout rate.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C07, E04, H06",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Same-trial material specifying completer/noncompleter data and original analysis assumptions"
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "What are the original randomization, concealment and design details?",
      "needed": "Original allocation/design, concealment, baseline tables and implementation material",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: What are the original randomization, concealment and design details?",
      "application_exception": "Do not arbitrarily mark cluster/crossover design as not applicable or fill all design details from the parent B2 axis.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E01",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Material specifying the actual comparative design in the protocol/report"
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "What are the ICDAS assessment, masking and measurement reliability?",
      "needed": "Original ICDAS criteria, assessors/masking, measurement conditions and reliability material",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: What are the ICDAS assessment, masking and measurement reliability?",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E03, C06",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Original methods/appendices linking actual readings, measurement limitations and results"
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Are patient, tooth and lesion units distinguished from repeated measurements?",
      "needed": "Patient–tooth–lesion relationships, aggregation/models and unit-specific denominator/measurement tables",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: Are patient, tooth and lesion units distinguished from repeated measurements?",
      "application_exception": "Do not transfer 91 patients or 52/39 participants to lesion/tooth denominators, or add repeated measurements/lesion counts as independent samples.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C02, C06, C07, E04",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Material specifying original measurement units and within-patient correlation/repeated measurements"
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What are six-month ICDAS, nominal exposure and assessment timing?",
      "needed": "Original schedules, baseline/six months, actual exposure/assessment and missing-data material",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: What are six-month ICDAS, nominal exposure and assessment timing?",
      "application_exception": "Do not present six months as identical actual exposure/complete follow-up for every patient or invent intermediate effects absent from original material.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C06, E03, E08",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Same-trial material linking assessment windows/exposure and time-specific outcomes"
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "What is the original direction of baseline and six-month final values?",
      "needed": "Original baseline/final tables, aggregation/dispersion, units/denominators and models",
      "role": "Required",
      "role_reason": "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_exception": "Do not newly subtract baseline/final values or infer their dispersion/CIs or original control conditions.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C06, E04, E05",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "The same report providing original final/baseline values, dispersion and outcome units"
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "What do changes of 0.80 versus 0.39 points represent?",
      "needed": "Original change definitions, sign/units, dispersion, analysis methods and tables",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: What do changes of 0.80 versus 0.39 points represent?",
      "application_exception": "Do not turn reductions of 0.80/0.39 into ICDAS increases or individual amounts of healing, or calculate new relative changes/effects.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C06, E04, E05",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Material reporting changes/final values and distinguishing within-arm/between-arm results"
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "What is the level of the original 0.41-point difference in change?",
      "needed": "Original between-arm change differences, models/units and CI/criterion tables",
      "role": "Required",
      "role_reason": "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_exception": "Use 0.41 points only as the original value; do not derive final-value differences, change ratios or new CIs.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E04, E05, C06",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Material reporting definitions/intervals and importance of original between-arm outcomes"
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "What are between-arm P=0.003 and the effect interval?",
      "needed": "Original statistical methods, test targets, effects/CIs and unit material",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: What are between-arm P=0.003 and the effect interval?",
      "application_exception": "Do not newly infer guaranteed individual remineralization, reduced caries or all forms of importance/clinical superiority from P=.003 alone.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E05, E04",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Original result tables linking actual models/intervals and testing objectives"
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "What are score aggregation, models and within-arm/between-arm analyses?",
      "needed": "Original score aggregation/statistical methods, SAP, models/units and tables",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: What are score aggregation, models and within-arm/between-arm analyses?",
      "application_exception": "Do not arbitrarily declare scores interval-scaled/normally distributed or models, adjustment or clustering not applicable.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E04, C06",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Material specifying original ICDAS analysis with units, models and assumptions"
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "How do completer effects differ from effects in the full randomized population?",
      "needed": "Original analysis populations, completion/exclusions, missing-data assumptions and alternative analyses",
      "role": "Required",
      "role_reason": "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_exception": "Do not turn completer analysis into full-population ITT or create new ITT values/bias magnitudes from the parent's explanation of avoidability.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E04, C07",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Material reporting randomized/completer populations and the actual scope of missing data"
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "What are the reported intervals and criteria for an important ICDAS difference?",
      "needed": "Original importance/clinical-linkage criteria, effect intervals and planning assumptions",
      "role": "Required",
      "role_reason": "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_exception": "Do not automatically use 0.41 points, statistical positivity or parent C50 as criteria establishing patient-important effects.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E05, E09",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If justified original criteria are provided, link them with score differences/intervals"
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "What do registration 'Not confirmed', prespecification and plans mean?",
      "needed": "Original registration/plans, endpoints/times, analysis versions and change material",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: What do registration 'Not confirmed', prespecification and plans mean?",
      "application_exception": "Do not convert 'Not confirmed' into unregistered/no registration, access failure or confirmed selective reporting.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E06, C09",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If actual plans are provided, distinguish original unverified status from new additional events/comparison scope"
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "What is the scope of multiplicity and disclosure of all outcomes/times?",
      "needed": "Protocol/SAP, all outcomes/times and reporting/change tables",
      "role": "Required",
      "role_reason": "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_exception": "Do not certify that all endpoints/times match plans or that selective reporting is absent from P=.003 and a single report.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E06, C08",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Material linking original plans and reports by outcome"
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "What are the original verdict and unmeasured scope for sibling caries prevention?",
      "needed": "The same trial's outcome list and direct clinical-event material for the prevention question",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E09, C08",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If direct event material is provided, distinguish connections for remineralization from separate questions/scopes"
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Does ICDAS remineralization also answer questions about new caries, fillings or tooth loss?",
      "needed": "Direct definitions, denominators and durations for new caries/treatment and tooth outcomes, with related validation",
      "role": "Required",
      "role_reason": "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_exception": "Do not extend positive remineralization/lesion scores to established caries prevention, avoidance of filling treatment or all dental-health benefits.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E09, E08",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If appropriate direct event material is provided, link scores and clinical outcomes separately"
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Are visual improvement and benefits in patient appearance/daily life the same?",
      "needed": "Patient-centered outcomes/scales, definitions, denominators/times and original results",
      "role": "Supplementary; required for extension to daily-life benefits",
      "role_reason": "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_exception": "Do not turn the original possibility of usefulness into verified patient satisfaction, daily-life improvement or cosmetic effects.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E09, E08",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If material directly reporting patient-centered outcomes is provided, distinguish it from lesion scores"
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "What are the concurrent or alternative effects of hygiene, fluoride, diet and retainers?",
      "needed": "Control/concurrent treatment, actual behavior/adherence and original baseline/analysis material",
      "role": "Required",
      "role_reason": "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_exception": "Do not declare all care identical or other causes absent from missing information, or generate oral-care instructions for users.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E02, H05",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Material linking common/different exposures and the original effect of interest in the same randomized comparison"
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "What are actual adherence, discontinuations and duration/dose comparisons?",
      "needed": "Original adherence/changes, exposure and direct-comparison/SAP material",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: What are actual adherence, discontinuations and duration/dose comparisons?",
      "application_exception": "Do not turn nominal six-month exposure into optimal duration/frequency, retainer-care or product-use recommendations.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E02, E08",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Material distinguishing direct exposure-specific outcomes in the same or appropriate additional research"
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "What direct material addresses other populations, subgroups and long-term maintenance?",
      "needed": "Extended populations/exposures, prespecified subgroups and duration-specific direct outcomes",
      "role": "Supplementary; required for extension",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: What direct material addresses other populations, subgroups and long-term maintenance?",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E08, E07",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If additional material is provided, specify differences from original populations, exposures and times in the connection"
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Do single-trial/R1/I1 history and current independent replication differ?",
      "needed": "Report/trial/population, product/source and outcome relationships, with direct independent material",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: Do single-trial/R1/I1 history and current independent replication differ?",
      "application_exception": "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.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C02, E07, C10, H07",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If material is provided, list same/separate/unclear populations and distinguish verification levels"
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "What history is represented by the original small-study/completer and duration defect descriptions?",
      "needed": "Complete parent-verdict history and actual design/analysis material",
      "role": "Required",
      "role_reason": "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_exception": "Do not copy parent checklist criteria as universal participant/duration rules for new conditions, current completed review or reassessment.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C09, E04, E05",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If corrections/method changes are provided, preserve original history separately from new events"
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "What is the scope of no patient/guardian-reported adverse effects over six months?",
      "needed": "Original adverse-effect reporting/collection, population/duration and definition/discontinuation material",
      "role": "Required",
      "role_reason": "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_exception": "Do not extend a no-reports sentence to zero events of all kinds, complete collection, individual harmlessness or long-term safety certification.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions E10, H01, H09",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Original material specifying reporting methods and the actual safety scope for the same exposure"
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "What are the adverse-effect denominators, dropout and reporting selection?",
      "needed": "Original safety-population/exposure, collection/missing reports and dropout/follow-up tables",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: What are the adverse-effect denominators, dropout and reporting selection?",
      "application_exception": "Do not fill verified safety denominators with the 91 efficacy participants or 106 randomized participants, or calculate new incidence/intervals from no reports.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions H04, H06, C07",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Safety material specifying denominators and reporting/follow-up selection"
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "What are harm occurrence, discontinuation and exposure/follow-up times?",
      "needed": "Original exposure/events, collection/discontinuation/recovery and timing material",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: What are harm occurrence, discontinuation and exposure/follow-up times?",
      "application_exception": "Do not transfer nominal six-month exposure/reporting to complete individual harm observation or future safety.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions H02, H04",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Original material specifying actual time and safety follow-up for the same exposure"
    },
    {
      "item_id": "N36",
      "question_type": "Evidence condition",
      "question": "What are the harm or alternative causes involving ingredients, retainers and baseline conditions?",
      "needed": "Original ingredients/products, baseline/concurrent conditions, event attribution and long-term/population-specific safety",
      "role": "Supplementary; required for extension of harm questions",
      "role_reason": "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_exception": "Do not exclude all events such as allergy/ingredient harms or generate product-suitability/use recommendations from no reports alone.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions H05, H08, E10",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If appropriate direct safety material is provided, distinguish differences from the original exposure/reporting scope"
    },
    {
      "item_id": "N37",
      "question_type": "Evidence condition",
      "question": "What is the original funding statement about no external funding?",
      "needed": "Original funding/resources, design/collection/analysis/publication roles and COI material",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: What is the original funding statement about no external funding?",
      "application_exception": "Do not certify absence of all funding/product/company involvement or COI, or completed current independence from the no-external-funding quotation.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C10",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If actual original declarations are provided, record checked levels/locations separately from unverified scope"
    },
    {
      "item_id": "N38",
      "question_type": "Evidence condition",
      "question": "Does unverified product-provision wording differ from actual absence of provision?",
      "needed": "Original product-provision/contracts, COI/acknowledgments and role declarations",
      "role": "Required",
      "role_reason": "Needed to record the scope of the selected ICDAS remineralization question separately: Does unverified product-provision wording differ from actual absence of provision?",
      "application_exception": "Do not convert unconfirmed wording into no product provision, external access failure or current independence certification.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C10, C09",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If original documents are provided, distinguish unverified/unreported status from the actual scope of provision/absence"
    },
    {
      "item_id": "N39",
      "question_type": "Evidence condition",
      "question": "What are the Korean/English texts, parent axes, false/null values and verdict history?",
      "needed": "Separate preservation of subclaim/parent, original languages/axes/empty values and verdict history",
      "role": "Required",
      "role_reason": "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_exception": "Do not fill unrecorded precision with 0 or declare parent B2, historical checking/cross-checking as newly completed model review or subclaim scores.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C01, C09, E06",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If actual corrections are provided, distinguish complete original text, events/versions and decisions by scope"
    },
    {
      "item_id": "N40",
      "question_type": "Evidence condition",
      "question": "Do the reference date, corrections/empty values differ from production dates/scope?",
      "needed": "Original publication/search/registration/correction versions and current production events",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions C09, C03",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If material/corrections are actually provided, distinguish original scope, complete before/after text and new events"
    },
    {
      "item_id": "N41",
      "question_type": "Evidence condition",
      "question": "What are the boundaries between score benefits/reported harms and current applicability/product selection?",
      "needed": "Direct material for extended populations/exposures, clinical events/patient outcomes and harms, with applicability differences",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "Chamgap's question-specific condition referring to the relevant stored summary record and family definitions H09, E09, E08, C09",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If material is provided and the scope allows, update research gaps while distinguishing the original sheet from other applicability questions"
    }
  ]
}