{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2926-s0", "verdict_number": "2926", "title": "F-ACP dental mousse · White spots after orthodontic treatment · Six-month ICDAS remineralization evidence sheet", "view_version": "1.0", "view_created_date": "2026-10-10", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from the existing values, scope and gaps in the specified stored summary. External abstracts, full texts and registrations were unread, with no access attempts. Review of the existing content is incomplete.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "White spots after orthodontic treatment; the original English term 'adolescents'; age, eligibility/exclusions and baseline lesion/tooth composition unverified", "intervention": "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", "endpoint": "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", "excluded_extensions": [ "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" ] }, "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The original candidate-boundary review wait is historical information; no model content/boundary review was performed in this work.", "uncertainty": "The original candidate-boundary review wait is historical information; no model content/boundary review was performed in this work.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Relationships among the original question, record and parent/sibling outcomes" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "There are no direct values for the selected subclaim score, status or axes.", "uncertainty": "There are no direct values for the selected subclaim score, status or axes.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "A separate record of original subclaim/parent verdicts, notes, scores/axes and missing values" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Follow-up/other report versions, overlapping populations, lesion/tooth relationships and current unique trial/participant totals are unresolved.", "uncertainty": "Follow-up/other report versions, overlapping populations, lesion/tooth relationships and current unique trial/participant totals are unresolved.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Relationship table for bibliography/trial families, patients/teeth/lesions and times/outcomes" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External public availability/acquisition, current content, access success and link operation were not verified.", "uncertainty": "External public availability/acquisition, current content, access success and link operation were not verified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Stored summaries and external original-material existence/acquisition, reading level and original locations" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Age range, sex, baseline lesion/caries risk, orthodontic/retainer status, eligibility/exclusions and recruitment are unverified.", "uncertainty": "Age range, sex, baseline lesion/caries risk, orthodontic/retainer status, eligibility/exclusions and recruitment are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original population eligibility/exclusions, baseline risk, age and orthodontic-status table" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Teeth/surfaces, lesion counts, lesion criteria, photography/drying, orthodontic completion timing, assessment environment and baseline balance are unverified.", "uncertainty": "Teeth/surfaces, lesion counts, lesion criteria, photography/drying, orthodontic completion timing, assessment environment and baseline balance are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original lesion/tooth distribution, selection criteria and assessment-environment/baseline table" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The finished trial product/manufacturer, ingredient concentrations, other additives, batches, provision/quality and equivalence between products are unverified.", "uncertainty": "The finished trial product/manufacturer, ingredient concentrations, other additives, batches, provision/quality and equivalence between products are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-product identity, composition/concentration and original product/provision information" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Application amount, frequency, retainer wear/cleaning, actual adherence, discontinuations/changes, contact time and route details are unverified.", "uncertainty": "Application amount, frequency, retainer wear/cleaning, actual adherence, discontinuations/changes, contact time and route details are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original product/retainer exposure, nominal/actual use and adherence/change material" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Direct definitions of control-arm fluoride/toothpaste, retainers, placebo/no treatment, hygiene/diet and common/arm-specific care are unverified.", "uncertainty": "Direct definitions of control-arm fluoride/toothpaste, retainers, placebo/no treatment, hygiene/diet and common/arm-specific care are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original control treatment, product/concentration, common/arm-specific care and actual implementation" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Randomized n by arm, selection/exposure/completion/assessment flow, tooth/lesion counts and original counts by exclusion reason are unverified.", "uncertainty": "Randomized n by arm, selection/exposure/completion/assessment flow, tooth/lesion counts and original counts by exclusion reason are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation → exposure → completion/assessment → analysis, and patient/lesion denominator tables" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original records 91/106, 14.2% dropout and completer analysis. Dropout rates, analysis inclusion and original observation/exposure are distinguished.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Arm-specific dropout/nonadherence, timing/reasons, dropout baseline/outcomes, missing-data handling and sensitivity are unverified.", "uncertainty": "Arm-specific dropout/nonadherence, timing/reasons, dropout baseline/outcomes, missing-data handling and sensitivity are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original dropout/exclusion, follow-up, baseline/missing-data handling and analysis flow" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The summary lacks parallel/cluster/crossover design, random-sequence/allocation concealment, baseline balance and implementation-role details.", "uncertainty": "The summary lacks parallel/cluster/crossover design, random-sequence/allocation concealment, baseline balance and implementation-role details.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original allocation/design, concealment, baseline tables and implementation material" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "ICDAS version, assessors/calibration, masking, photographs/examinations, inter-assessment agreement, missing assessments and arm differences are unverified.", "uncertainty": "ICDAS version, assessors/calibration, masking, photographs/examinations, inter-assessment agreement, missing assessments and arm differences are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original ICDAS criteria, assessors/masking, measurement conditions and reliability material" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "ICDAS aggregation units, lesions per patient, selected teeth/surfaces, cluster/repeated-measure handling and denominators are unverified.", "uncertainty": "ICDAS aggregation units, lesions per patient, selected teeth/surfaces, cluster/repeated-measure handling and denominators are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Patient–tooth–lesion relationships, aggregation/models and unit-specific denominator/measurement tables" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original records six-month ICDAS and six-month retainer/mousse exposure. Individual actual use duration, assessment windows and intermediate measurements are separate matters.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Orthodontic completion/baseline, final assessment timing, allowed windows, intermediate times, data cutoff and actual exposure/safety follow-up are unverified.", "uncertainty": "Orthodontic completion/baseline, final assessment timing, allowed windows, intermediate times, data cutoff and actual exposure/safety follow-up are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original schedules, baseline/six months, actual exposure/assessment and missing-data material" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Details of each value's mean/median, dispersion/CI, aggregation/measurement unit, adjustment and original timing are unverified.", "uncertainty": "Details of each value's mean/median, dispersion/CI, aggregation/measurement unit, adjustment and original timing are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original baseline/final tables, aggregation/dispersion, units/denominators and models" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Details of sign/aggregation, change dispersion, paired measurements/adjustment and within-arm versus between-arm tests are unverified.", "uncertainty": "Details of sign/aggregation, change dispersion, paired measurements/adjustment and within-arm versus between-arm tests are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original change definitions, sign/units, dispersion, analysis methods and tables" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Adjustment, dispersion/CI, aggregation/clustering/repeated measurements and clinical-importance criteria are unverified.", "uncertainty": "Adjustment, dispersion/CI, aggregation/clustering/repeated measurements and clinical-importance criteria are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original between-arm change differences, models/units and CI/criterion tables" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original tests/models, CIs, dispersion, multiplicity, measurement/analysis units and importance are unverified.", "uncertainty": "Original tests/models, CIs, dispersion, multiplicity, measurement/analysis units and importance are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original statistical methods, test targets, effects/CIs and unit material" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Scale treatment, aggregation, baseline adjustment, clustering/repeated measurements, analysis assumptions, sensitivity and change dispersion are unverified.", "uncertainty": "Scale treatment, aggregation, baseline adjustment, clustering/repeated measurements, analysis assumptions, sensitivity and change dispersion are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original score aggregation/statistical methods, SAP, models/units and tables" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Allocation/adherence effects, completion selection, arm-specific exclusions and original ITT/sensitivity outcomes are unverified.", "uncertainty": "Allocation/adherence effects, completion selection, arm-specific exclusions and original ITT/sensitivity outcomes are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original analysis populations, completion/exclusions, missing-data assumptions and alternative analyses" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "Original changes/differences and P are retained. Although ICDAS is lower-is-better, the summary lacks justified important-difference/patient-utility criteria and CIs.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Minimum important differences, stage/lesion-recovery criteria, intervals/dispersion and power/original plans are unverified.", "uncertainty": "Minimum important differences, stage/lesion-recovery criteria, intervals/dispersion and power/original plans are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original importance/clinical-linkage criteria, effect intervals and planning assumptions" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "The existing registration identifier record is the string 'Not confirmed'. The current registration ID remains null; this original record and unverified scope are retained.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Registration/protocol/SAP, original primary/secondary outcomes, analyses/times and change history are externally unread.", "uncertainty": "Registration/protocol/SAP, original primary/secondary outcomes, analyses/times and change history are externally unread.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration/plans, endpoints/times, analysis versions and change material" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Full outcome lists, multiplicity adjustment, exploratory/confirmatory status, prespecified analyses/changes and unpublished outcomes are unverified.", "uncertainty": "Full outcome lists, multiplicity adjustment, exploratory/confirmatory status, prespecified analyses/changes and unpublished outcomes are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Protocol/SAP, all outcomes/times and reporting/change tables" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original clinical-event definitions/collection, long-term outcomes, registration plans and current related material were not verified in this work.", "uncertainty": "Original clinical-event definitions/collection, long-term outcomes, registration plans and current related material were not verified in this work.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The same trial's outcome list and direct clinical-event material for the prevention question" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Direct clinical-event effects, units/denominators, duration, surrogate prediction/mediation and long-term material are unverified.", "uncertainty": "Direct clinical-event effects, units/denominators, duration, surrogate prediction/mediation and long-term material are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct definitions, denominators and durations for new caries/treatment and tooth outcomes, with related validation" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Patient-reported appearance/satisfaction, daily life/quality of life, symptoms, persistence, importance and denominators are unverified.", "uncertainty": "Patient-reported appearance/satisfaction, daily life/quality of life, symptoms, persistence, importance and denominators are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Patient-centered outcomes/scales, definitions, denominators/times and original results" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Arm-specific concurrent fluoride/toothpaste, diet/hygiene, retainers, natural course, intervention/assessment differences and handling methods are unverified.", "uncertainty": "Arm-specific concurrent fluoride/toothpaste, diet/hygiene, retainers, natural course, intervention/assessment differences and handling methods are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Control/concurrent treatment, actual behavior/adherence and original baseline/analysis material" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Adherence measurement/distribution, discontinuations/changes, actual contact/amount and direct frequency/duration/formulation comparisons are unverified.", "uncertainty": "Adherence measurement/distribution, discontinuations/changes, actual contact/amount and direct frequency/duration/formulation comparisons are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original adherence/changes, exposure and direct-comparison/SAP material" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Prespecified subgroups/interactions, direct population/product comparisons, longer follow-up and persistence after stopping are unverified.", "uncertainty": "Prespecified subgroups/interactions, direct population/product comparisons, longer follow-up and persistence after stopping are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Extended populations/exposures, prespecified subgroups and duration-specific direct outcomes" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Current additional/follow-up reports, direct replication in other populations/products and material-family/independence relationships were not newly searched.", "uncertainty": "Current additional/follow-up reports, direct replication in other populations/products and material-family/independence relationships were not newly searched.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report/trial/population, product/source and outcome relationships, with direct independent material" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "These case-specific conditions did not automatically adopt the original 200 participants/12 weeks as minimum criteria or reassess them as new defect scores.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete parent-verdict history and actual design/analysis material" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Event definitions, systematic/spontaneous collection, grades/discontinuations, original safety denominators and actual records/verification are unverified.", "uncertainty": "Event definitions, systematic/spontaneous collection, grades/discontinuations, original safety denominators and actual records/verification are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original adverse-effect reporting/collection, population/duration and definition/discontinuation material" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Safety populations, reporting/exposure/follow-up, events among dropouts, missing reports/recall and arm-specific detection differences are unverified.", "uncertainty": "Safety populations, reporting/exposure/follow-up, events among dropouts, missing reports/recall and arm-specific detection differences are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original safety-population/exposure, collection/missing reports and dropout/follow-up tables" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original safety-reporting window is six months. Actual mousse/retainer exposure, onset/recovery, discontinuation/reuse and subsequent observation require separate material.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Event chronology, actual contact duration, discontinuation/re-exposure, collection windows/original cutoff and loss to follow-up are unverified.", "uncertainty": "Event chronology, actual contact duration, discontinuation/re-exposure, collection windows/original cutoff and loss to follow-up are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original exposure/events, collection/discontinuation/recovery and timing material" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Additives, baseline/concurrent conditions, other products, actual exposure, attribution/alternatives, vulnerable populations/long-term and rare harms are unverified.", "uncertainty": "Additives, baseline/concurrent conditions, other products, actual exposure, attribution/alternatives, vulnerable populations/long-term and rare harms are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original ingredients/products, baseline/concurrent conditions, event attribution and long-term/population-specific safety" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original contracts, institutional/internal funding, sponsor/author roles, complete COI and data access are externally unread.", "uncertainty": "Original contracts, institutional/internal funding, sponsor/author roles, complete COI and data access are externally unread.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding/resources, design/collection/analysis/publication roles and COI material" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original records that trial-product provision wording was not identified in the publicly checked COI/acknowledgments. Parent I1 represents that historical checked scope.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Complete product supply/in-kind support, author employment/patents, COI/acknowledgments, contracts and current changes are unverified.", "uncertainty": "Complete product supply/in-kind support, author employment/patents, COI/acknowledgments, contracts and current changes are unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original product-provision/contracts, COI/acknowledgments and role declarations" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original values/axes and historical checks were not inherited as current subclaim scores, condition fulfillment or completed review.", "uncertainty": "Original values/axes and historical checks were not inherited as current subclaim scores, condition fulfillment or completed review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate preservation of subclaim/parent, original languages/axes/empty values and verdict history" }, { "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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Evidence reference-date/classification records are absent, and no registration/correction/retraction, new search/material or link comparison was performed.", "uncertainty": "Evidence reference-date/classification records are absent, and no registration/correction/retraction, new search/material or link comparison was performed.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original publication/search/registration/correction versions and current production 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", "current_reports": [ "R01" ], "existence": "Relevant text in the stored summary; detailed original-material existence/acquisition unverified", "acquired_read": "Summary read; external materials not read", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Current products/guidelines, individual oral status, other compositions/controls and direct material on current benefit/harm applicability were not verified.", "uncertainty": "Current products/guidelines, individual oral status, other compositions/controls and direct material on current benefit/harm applicability were not verified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct material for extended populations/exposures, clinical events/patient outcomes and harms, with applicability differences" } ], "reports": [ { "report_id": "R01", "title": "Ciribè M, et al. Biomedicines. 2024;12:1202. PMID: 38927409.", "url": "https://pubmed.ncbi.nlm.nih.gov/38927409/", "report_type": "Preserved original randomized-trial report summary", "existence": "Report slot in the specified review summary's evidence/citation lists", "acquired_read": "Summary read; external abstracts, full texts and registrations unread", "study_family": "F01", "independent_replication": false, "observed_result": "Change 0.80 versus 0.39 points, between-arm P=0.003; lower is better", "result_level": "Historical funding/COI/acknowledgment and verdict-check descriptions; no current paper/plan reading", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Complete original-byte copy of the stored summary", "access_status": "Stored summary copy acquired and summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T18:52:04.707378+09:00", "qualification": "The complete parent/subclaims, original ICDAS values, denominators, sources/registration and safety history were read for production. This is not original-paper/registration reading." }, { "material_type": "External abstract", "public_status": "External material unread; no access attempts", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the original PubMed bibliography URL is linked; no abstract acquisition/reading or link testing." }, { "material_type": "External full text", "public_status": "External material unread; no access attempts", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original URL establishes bibliographic identity, not certification of full-text access, acquisition or reading." }, { "material_type": "External registration", "public_status": "External material unread; no access attempts", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "Required protocol", "public_status": "Not acquired; detailed existence unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original eligibility, control fluoride, ingredients/exposure, ICDAS reading/timing and primary/secondary/change plans are needed." }, { "material_type": "Required analysis plan", "public_status": "Not acquired; detailed existence unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original material on patient/tooth/lesion units, aggregation/models, repeated measurements/clustering, missing data/denominators/CIs and importance is needed." }, { "material_type": "Required result tables and safety material", "public_status": "Not acquired; detailed existence unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original final/change/between-arm tables, dispersion/CIs, dropout/exposure, safety-reporting populations/times and attribution are needed." }, { "material_type": "Required funding and interests", "public_status": "Not acquired; detailed existence unverified", "access_status": "Access not attempted; not obtained", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "No external funding/unverified product wording are historical records. Complete declarations, product provision, sponsor/author roles are externally unread." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/38927409/" } ] } ], "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-10", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The reader view and materials were prepared from the existing 41 items. No new clinical search, verification-status changes or scoring were performed." } ], "language": "en", "translation_date": "2026-10-10" }