{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2926-s1", "verdict_number": "2926", "title": "F-ACP dental mousse × Prevention of incident caries 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": "Review of the existing content is incomplete. External abstracts, full texts, registration records, protocols and SAPs have not been read, and access has not been attempted.", "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": "Patients with post-orthodontic white spots; distinguish the original English description of adolescents and 106 randomized/91 completers (52/39) from the unverified caries denominator", "intervention": "Historical research exposure to F-ACP dental mousse in an Essix retainer for six months; this is not product-use guidance", "dose": null, "comparator": "Original control scores and randomized design; exact control composition, concomitant care and appliance conditions remain unverified", "endpoint": "Selected prevention of new caries; original grade ? and note 'not measured'; six-month ICDAS change is surrogate-outcome context", "duration": "Original six-month lesion scores; caries-event observation windows and long-term direct outcomes remain unverified", "excluded_extensions": [ "Reusing existing ICDAS scores/visible remineralization, P=.003 and the .41 difference as effects on incident caries, fillings or daily-life outcomes", "Filling the unmeasured-caries grade ? and note with 0 events, zero effect, confirmed prevention or a new grade/score", "Calculating new differences, rates, CIs, individual targets or important differences from baseline 1.80/1.92, final 1.00/1.53 and .80/.39/.41", "Calculating new dropout counts/rates, caries/lesion/safety denominators or remaining populations from 106/91/52/39 and the original 14.2%", "Adding people, teeth, lesions, repeated time points, parent/sibling questions or one report as new independent trials/participants", "Filling an unclear original comparator with no treatment, appliance alone, an equivalent-fluoride control, concomitant care or blinding", "Reusing the F-ACP fluoride/carbonate complex as equivalent composition or caries effects for all CPP-ACP/fluoride products", "Changing the original no-external-funding statement and unidentified product provision in the publicly checked scope into no free products, no employee involvement/COI or new independence certification", "Reusing six-month non-reporting of adverse effects by patients/caregivers or the Good label as zero risk, long-term safety, safety for all patients or product safety", "Using original distribution/recommendation history as current sales/policy verification, product choice, amount, frequency, suitability or caries-prevention/treatment guidance", "Extending six-month surrogate findings from one completer trial into persistence after exposure or long-term clinical effects on caries/daily life", "Inheriting parent C50/original axes, past cross-checks, limitation checks or full-text review as subclaim values, QA in this work or external reading", "New searches/APIs, numerical calculations, invented numbers, new effects/CIs/grades, independence certification or guidance on product/treatment selection, use, suitability or implementation" ] }, "requirements": [ { "item_id": "N01", "question_type": "Efficacy comparison and presentation of stored material", "question": "Which existing values are recorded for the caries-prevention question?", "needed": "Distinguish subclaim grade ?, note and missing score/status/axes from parent C50/axes", "role": "Required", "role_reason": "This production item distinguishes \"Distinguish subclaim grade ?, note and missing score/status/axes from parent C50/axes\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Distinguish subclaim grade ?, note and missing score/status/axes from parent C50/axes\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Distinguish subclaim grade ?, note and missing score/status/axes from parent C50/axes\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected existing question is 'prevention of incident caries', with original grade ? and note 'not measured'. Parent C50, Good and S/R1/I1/E+/B2 are context from the existing white-spot remineralization verdict; subclaim score, status and axes are absent.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. No new caries-prevention grade/effect is created and parent values are not inherited. Review of the existing content remains incomplete.", "missingness": "No new caries-prevention grade/effect is created and parent values are not inherited.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Distinguish subclaim grade ?, note and missing score/status/axes from parent C50/axes\"" }, { "item_id": "N02", "question_type": "Efficacy comparison and presentation of stored material", "question": "Was incident caries actually measured?", "needed": "Distinguish incident caries/new clinical events from existing lesion scores", "role": "Required", "role_reason": "This production item distinguishes \"Distinguish incident caries/new clinical events from existing lesion scores\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Distinguish incident caries/new clinical events from existing lesion scores\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Distinguish incident caries/new clinical events from existing lesion scores\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing note and counterview say reductions in new caries/filling treatment were not measured. This is not changed into 0 events, confirmed prevention or a numerical finding of no effect.", "condition_status": "Unverified", "status_reason": "Record from the stored summary. Currently needed information is unverified. Direct caries definitions, events/denominators, observation windows and between-group effects/intervals are absent or unverified. Review of the existing content remains incomplete.", "missingness": "Direct caries definitions, events/denominators, observation windows and between-group effects/intervals are absent or unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Distinguish incident caries/new clinical events from existing lesion scores\"" }, { "item_id": "N03", "question_type": "Efficacy comparison and presentation of stored material", "question": "Is existing white-spot ICDAS change the same as prevention of new caries?", "needed": "Existing lesions/visible remineralization, ICDAS and new events", "role": "Required", "role_reason": "This production item distinguishes \"Existing lesions/visible remineralization, ICDAS and new events\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Existing lesions/visible remineralization, ICDAS and new events\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Existing lesions/visible remineralization, ICDAS and new events\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original endpoint is the six-month ICDAS white-spot score, where higher is worse. Decreases in existing lesion scores are not transferred into incident-caries rates, fillings/pain or improved daily functioning.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. New lesion/caries events, individual links to progression/recovery of existing lesions and clinical-event results remain unverified. Review of the existing content remains incomplete.", "missingness": "New lesion/caries events, individual links to progression/recovery of existing lesions and clinical-event results remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Existing lesions/visible remineralization, ICDAS and new events\"" }, { "item_id": "N04", "question_type": "Efficacy comparison and presentation of stored material", "question": "What outcome scope do ICDAS change values and P describe?", "needed": "Original 0.80/0.39 points, P=.003 and lower-is-better direction", "role": "Required", "role_reason": "This production item distinguishes \"Original 0.80/0.39 points, P=.003 and lower-is-better direction\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Original 0.80/0.39 points, P=.003 and lower-is-better direction\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Original 0.80/0.39 points, P=.003 and lower-is-better direction\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original ICDAS reduction of 0.80 versus 0.39 points, with between-group P=.003, is the original lesion-score result. It is not changed into a caries-prevention rate, independent-living/patient responder proportion or new between-group difference/CI.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. Group/lesion denominators, models, exact CIs and prespecified importance remain unverified. Review of the existing content remains incomplete.", "missingness": "Group/lesion denominators, models, exact CIs and prespecified importance remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Original 0.80/0.39 points, P=.003 and lower-is-better direction\"" }, { "item_id": "N05", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are baseline/six-month scores and the original change difference retained?", "needed": "Roles of 1.80→1.00, 1.92→1.53 and the original 0.41 difference", "role": "Required", "role_reason": "This production item distinguishes \"Roles of 1.80→1.00, 1.92→1.53 and the original 0.41 difference\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Roles of 1.80→1.00, 1.92→1.53 and the original 0.41 difference\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Roles of 1.80→1.00, 1.92→1.53 and the original 0.41 difference\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing Korean verdict rationale's mousse 1.80→1.00, control 1.92→1.53 and change difference of 0.41 points are retained. No new reductions/differences are calculated from scores or converted into caries incidence.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. Analysis populations, adjustment/rounding, intervals and scale aggregation details for scores/change differences remain unverified. Review of the existing content remains incomplete.", "missingness": "Analysis populations, adjustment/rounding, intervals and scale aggregation details for scores/change differences remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Roles of 1.80→1.00, 1.92→1.53 and the original 0.41 difference\"" }, { "item_id": "N06", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does a clinically important minimum difference mean caries prevention?", "needed": "Distinguish lesion-score importance, direct clinical events and between-group intervals", "role": "Required", "role_reason": "This production item distinguishes \"Distinguish lesion-score importance, direct clinical events and between-group intervals\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Distinguish lesion-score importance, direct clinical events and between-group intervals\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4; Chamgap's own limits on extension", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Distinguish lesion-score importance, direct clinical events and between-group intervals\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Statistical ICDAS change and original parent C50 are historical surrogate-outcome context. Neither 0.41 points nor P is used as a prespecified important difference, new caries-prevention effect or individual target.", "condition_status": "Unverified", "status_reason": "Record from the stored summary. Currently needed information is unverified. Prespecified ICDAS importance, between-group CIs and validated links to clinical events remain unverified. Review of the existing content remains incomplete.", "missingness": "Prespecified ICDAS importance, between-group CIs and validated links to clinical events remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Distinguish lesion-score importance, direct clinical events and between-group intervals\"" }, { "item_id": "N07", "question_type": "Efficacy comparison and presentation of stored material", "question": "Were filling treatment, pain or oral daily-life outcomes reported?", "needed": "Filling treatment/oral function, appearance assessment and new clinical outcomes", "role": "Required", "role_reason": "This production item distinguishes \"Filling treatment/oral function, appearance assessment and new clinical outcomes\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Filling treatment/oral function, appearance assessment and new clinical outcomes\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M03 §3.2.4; Chamgap's own limits on extension", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Filling treatment/oral function, appearance assessment and new clinical outcomes\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing counterview records that reduced filling treatment was not measured. Wording that visible remineralization may be useful is not turned into numerical pain, chewing/daily-life improvement or actual treatment reduction.", "condition_status": "Unverified", "status_reason": "Record from the stored summary. Currently needed information is unverified. Direct filling/treatment, pain/oral daily-life scales, denominators/periods and between-group values remain unverified. Review of the existing content remains incomplete.", "missingness": "Direct filling/treatment, pain/oral daily-life scales, denominators/periods and between-group values remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Filling treatment/oral function, appearance assessment and new clinical outcomes\"" }, { "item_id": "N08", "question_type": "Efficacy comparison and presentation of stored material", "question": "Which patients after orthodontic treatment were included?", "needed": "Post-orthodontic white spots, original English adolescent description and eligibility/baseline scope", "role": "Required", "role_reason": "This production item distinguishes \"Post-orthodontic white spots, original English adolescent description and eligibility/baseline scope\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Post-orthodontic white spots, original English adolescent description and eligibility/baseline scope\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Post-orthodontic white spots, original English adolescent description and eligibility/baseline scope\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original population has white spots after orthodontic treatment, and the existing English research account describes adolescents. This is not extended to all ages/teeth, general caries prevention or populations with other conditions.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. Exact ages, eligibility, orthodontic/baseline lesions, oral risk, comorbidities and recruitment conditions remain unverified. Review of the existing content remains incomplete.", "missingness": "Exact ages, eligibility, orthodontic/baseline lesions, oral risk, comorbidities and recruitment conditions remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Post-orthodontic white spots, original English adolescent description and eligibility/baseline scope\"" }, { "item_id": "N09", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are the original F-ACP components the same as other product families?", "needed": "Fluoride/carbonate-containing amorphous calcium phosphate and boundaries with CPP-ACP/fluoride products", "role": "Required", "role_reason": "This production item distinguishes \"Fluoride/carbonate-containing amorphous calcium phosphate and boundaries with CPP-ACP/fluoride products\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Fluoride/carbonate-containing amorphous calcium phosphate and boundaries with CPP-ACP/fluoride products\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Fluoride/carbonate-containing amorphous calcium phosphate and boundaries with CPP-ACP/fluoride products\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original F-ACP is an amorphous calcium-phosphate complex containing fluoride and carbonate. Fluoride/CPP-ACP in the original product-distribution wording is not reused as the same composition or preventive effect as this F-ACP.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. Exact concentrations, product identity, lots/manufacturing, formulation equivalence and direct material for other products remain unverified. Review of the existing content remains incomplete.", "missingness": "Exact concentrations, product identity, lots/manufacturing, formulation equivalence and direct material for other products remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Fluoride/carbonate-containing amorphous calcium phosphate and boundaries with CPP-ACP/fluoride products\"" }, { "item_id": "N10", "question_type": "Efficacy comparison and presentation of stored material", "question": "What historical research conditions did the Essix retainer and six-month exposure describe?", "needed": "Original mousse in a retainer, actual exposure/adherence and control", "role": "Required", "role_reason": "This production item distinguishes \"Original mousse in a retainer, actual exposure/adherence and control\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Original mousse in a retainer, actual exposure/adherence and control\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Original mousse in a retainer, actual exposure/adherence and control\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original trial applied mousse in an Essix retainer for six months. This exposure is not changed into amounts/frequency, implementation/suitability instructions or product recommendations.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. Actual amounts/frequency, adherence/crossover, group exposure/concomitant care and control-management details remain unverified. Review of the existing content remains incomplete.", "missingness": "Actual amounts/frequency, adherence/crossover, group exposure/concomitant care and control-management details remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Original mousse in a retainer, actual exposure/adherence and control\"" }, { "item_id": "N11", "question_type": "Efficacy comparison and presentation of stored material", "question": "What did the control group receive?", "needed": "Mousse-control composition/appliance, common care and placebo definition", "role": "Required", "role_reason": "This production item distinguishes \"Mousse-control composition/appliance, common care and placebo definition\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Mousse-control composition/appliance, common care and placebo definition\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Mousse-control composition/appliance, common care and placebo definition\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original material contains control scores and a randomized controlled design, but absent exact control composition, appliance or oral care is not filled in. No treatment, appliance alone or an equivalent-fluoride control is not assumed.", "condition_status": "Unverified", "status_reason": "Record from the stored summary. Currently needed information is unverified. Control formulations, common/group care, fluoride/toothpaste/other exposures and blinding remain unverified. Review of the existing content remains incomplete.", "missingness": "Control formulations, common/group care, fluoride/toothpaste/other exposures and blinding remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Mousse-control composition/appliance, common care and placebo definition\"" }, { "item_id": "N12", "question_type": "Efficacy comparison and presentation of stored material", "question": "What is known about allocation and assessor blinding in the randomized design?", "needed": "Allocation-sequence generation/concealment and measurement of ICDAS/caries events", "role": "Required", "role_reason": "This production item distinguishes \"Allocation-sequence generation/concealment and measurement of ICDAS/caries events\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Allocation-sequence generation/concealment and measurement of ICDAS/caries events\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Allocation-sequence generation/concealment and measurement of ICDAS/caries events\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original is a randomized controlled trial. Its original B2 axis or randomized label is not inherited as verification of allocation concealment, patient/assessor blinding or clinical caries-event adjudication.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. Allocation/concealment, assessors, ICDAS measurement/photographs and blinding/awareness details remain unverified. Review of the existing content remains incomplete.", "missingness": "Allocation/concealment, assessors, ICDAS measurement/photographs and blinding/awareness details remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Allocation-sequence generation/concealment and measurement of ICDAS/caries events\"" }, { "item_id": "N13", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the denominators of 106 randomized, 91 completers and 52/39?", "needed": "Distinguish randomized/completer populations, group denominators and original 14.2% attrition", "role": "Required", "role_reason": "This production item distinguishes \"Distinguish randomized/completer populations, group denominators and original 14.2% attrition\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Distinguish randomized/completer populations, group denominators and original 14.2% attrition\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Distinguish randomized/completer populations, group denominators and original 14.2% attrition\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "106 randomized, 91 completers (mousse 52/control 39) and original attrition of 14.2% are retained. No new dropout counts/rates, caries-observed participants per group or event denominators are calculated.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. Group follow-up, exclusions, dropout reasons, unmeasured clinical events and missing-data responses remain unverified. Review of the existing content remains incomplete.", "missingness": "Group follow-up, exclusions, dropout reasons, unmeasured clinical events and missing-data responses remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Distinguish randomized/completer populations, group denominators and original 14.2% attrition\"" }, { "item_id": "N14", "question_type": "Efficacy comparison and presentation of stored material", "question": "Can completer analysis describe effects in everyone randomized?", "needed": "Scope of original completers, ITT/missing-data plans and baseline/within-group selection", "role": "Required", "role_reason": "This production item distinguishes \"Scope of original completers, ITT/missing-data plans and baseline/within-group selection\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Scope of original completers, ITT/missing-data plans and baseline/within-group selection\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Scope of original completers, ITT/missing-data plans and baseline/within-group selection\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original account describes 91/106 completer analysis as a limitation. Completer ICDAS values are not extended to caries-prevention effects in all 106 participants, no missing data or complete follow-up.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. ITT/missing-data handling, sensitivity analyses, discontinuers' outcomes and prespecified plans remain unverified. Review of the existing content remains incomplete.", "missingness": "ITT/missing-data handling, sensitivity analyses, discontinuers' outcomes and prespecified plans remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Scope of original completers, ITT/missing-data plans and baseline/within-group selection\"" }, { "item_id": "N15", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are people, teeth, lesions and repeated measurements the same units?", "needed": "Distinguish patient denominators, ICDAS aggregation/lesions and repeated-measure correlations", "role": "Required", "role_reason": "This production item distinguishes \"Distinguish patient denominators, ICDAS aggregation/lesions and repeated-measure correlations\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Distinguish patient denominators, ICDAS aggregation/lesions and repeated-measure correlations\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Distinguish patient denominators, ICDAS aggregation/lesions and repeated-measure correlations\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original 106/91 and 52/39 are person denominators. How ICDAS was aggregated by tooth/lesion is unknown; each tooth/time point is not counted as a new participant/independent trial.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. Lesion/tooth counts, within-person correlation, measurement/analysis models and group/time-point denominators remain unverified. Review of the existing content remains incomplete.", "missingness": "Lesion/tooth counts, within-person correlation, measurement/analysis models and group/time-point denominators remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Distinguish patient denominators, ICDAS aggregation/lesions and repeated-measure correlations\"" }, { "item_id": "N16", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the actual observation windows for six-month ICDAS and caries incidence?", "needed": "Original six-month surrogate outcome and clinical-event periods/follow-up", "role": "Required", "role_reason": "This production item distinguishes \"Original six-month surrogate outcome and clinical-event periods/follow-up\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Original six-month surrogate outcome and clinical-event periods/follow-up\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Original six-month surrogate outcome and clinical-event periods/follow-up\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original trial period/ICDAS assessment is six months. It is not labeled as 0 caries events or prevention during that period, persistence afterward or confirmed long-term prevention.", "condition_status": "Unverified", "status_reason": "Record from the stored summary. Currently needed information is unverified. Caries observation/adjudication windows, long-term follow-up, events/missing data and periods after exposure ends remain unverified. Review of the existing content remains incomplete.", "missingness": "Caries observation/adjudication windows, long-term follow-up, events/missing data and periods after exposure ends remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Original six-month surrogate outcome and clinical-event periods/follow-up\"" }, { "item_id": "N17", "question_type": "Efficacy comparison and presentation of stored material", "question": "What prespecified endpoint hierarchy included ICDAS and caries events?", "needed": "Original lesion-score endpoint, unmeasured caries and prespecified plans/multiplicity", "role": "Required", "role_reason": "This production item distinguishes \"Original lesion-score endpoint, unmeasured caries and prespecified plans/multiplicity\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Original lesion-score endpoint, unmeasured caries and prespecified plans/multiplicity\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Original lesion-score endpoint, unmeasured caries and prespecified plans/multiplicity\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing evidence-list endpoint is six-month ICDAS. Unmeasured caries events are not turned into a primary time point, confirmatory endpoint, prespecified comparison or responder analysis.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. Protocols/SAPs, score/clinical-event plans, multiplicity and prespecified importance remain unverified. Review of the existing content remains incomplete.", "missingness": "Protocols/SAPs, score/clinical-event plans, multiplicity and prespecified importance remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Original lesion-score endpoint, unmeasured caries and prespecified plans/multiplicity\"" }, { "item_id": "N18", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are the same report, sibling remineralization question and population kept separate from independent totals?", "needed": "Ciribè2024, 106/91 participants and shared lesion/caries questions", "role": "Required", "role_reason": "This production item distinguishes \"Ciribè2024, 106/91 participants and shared lesion/caries questions\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Ciribè2024, 106/91 participants and shared lesion/caries questions\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Ciribè2024, 106/91 participants and shared lesion/caries questions\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The parent/sibling ICDAS question and this caries-prevention question share the same Ciribè2024 report/population. Teeth/lesions, time points, scores/safety and the two questions are not added as new independent trials or total participants.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. Unique clinical trial/participant and independent-replication totals have not been verified and are not recorded. Review of the existing content remains incomplete.", "missingness": "Unique clinical trial/participant and independent-replication totals have not been verified and are not recorded.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Ciribè2024, 106/91 participants and shared lesion/caries questions\"" }, { "item_id": "N19", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are no external funding and unverified product provision/COI the same?", "needed": "Original no-external-funding statement, unidentified products in the publicly checked scope and actual roles", "role": "Required", "role_reason": "This production item distinguishes \"Original no-external-funding statement, unidentified products in the publicly checked scope and actual roles\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Original no-external-funding statement, unidentified products in the publicly checked scope and actual roles\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Original no-external-funding statement, unidentified products in the publicly checked scope and actual roles\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original funding account says no external funding was received and product-provision wording was not identified in publicly checked COI/acknowledgment text. External full text was not read in this work; this is not changed into no free product support or no company, employee or COI involvement.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. Institutional funding, products/manufacturers, employee authors, research/writing contributions, COI and supply agreements remain unverified. Review of the existing content remains incomplete.", "missingness": "Institutional funding, products/manufacturers, employee authors, research/writing contributions, COI and supply agreements remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Original no-external-funding statement, unidentified products in the publicly checked scope and actual roles\"" }, { "item_id": "N20", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does 'registration not identified' verify actual absence?", "needed": "Original registration-identifier record, unrecorded identifier and unread registration/protocol/SAP", "role": "Required", "role_reason": "This production item distinguishes \"Original registration-identifier record, unrecorded identifier and unread registration/protocol/SAP\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Original registration-identifier record, unrecorded identifier and unread registration/protocol/SAP\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Original registration-identifier record, unrecorded identifier and unread registration/protocol/SAP\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original registration-identifier record says 'not identified'; the actual identifier remains unrecorded. This is not changed into a confirmed number, absence of registration or absence of a prespecified caries plan.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. Registration texts/changes, protocols/SAPs and endpoint/missing-data plans have not been read or accessed. Review of the existing content remains incomplete.", "missingness": "Registration texts/changes, protocols/SAPs and endpoint/missing-data plans have not been read or accessed.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Original registration-identifier record, unrecorded identifier and unread registration/protocol/SAP\"" }, { "item_id": "N21", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "What collection scope underlies six-month non-reporting of adverse effects?", "needed": "Patient/caregiver reports, denominators/time and distinction from zero risk", "role": "Supplementary", "role_reason": "This production item distinguishes \"Patient/caregiver reports, denominators/time and distinction from zero risk\" to link materials needed for the selected question with the currently available material.", "application_exception": "Address gaps in harm material for the selected new-caries-prevention question. Do not use ICDAS, original non-reporting of adverse effects or the Good wording to judge overall safety or generate harm rates or guidance on product choice, use or suitability.", "criterion": "Relevant source material and analysis scope for \"Patient/caregiver reports, denominators/time and distinction from zero risk\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M19 §19.1.2–19.2.4; Chamgap's own application; M19 §19.1.2–19.2.4; detailed distinctions are Chamgap's own design; M19 §19.1.2–19.2.4; Chamgap's own application; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap's own application; M19 §19.1.2–19.2.4; Chamgap's own application; Chamgap's own interpretive boundary. M19 principles are referenced; no official causality tool was run", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Patient/caregiver reports, denominators/time and distinction from zero risk\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original safety wording says no adverse effects were reported by patients or caregivers over six months. The original Good label is not extended to overall zero risk, all patients, other products, long-term safety or use recommendations.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. Collection/questions, safety denominators, discontinuers/exposure, verification, severity/CIs and long-term/vulnerable-group harms remain unverified. Review of the existing content remains incomplete.", "missingness": "Collection/questions, safety denominators, discontinuers/exposure, verification, severity/CIs and long-term/vulnerable-group harms remain unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Patient/caregiver reports, denominators/time and distinction from zero risk\"" }, { "item_id": "N22", "question_type": "Efficacy comparison and presentation of stored material", "question": "Do sales/recommendation or other-product/population statements establish caries prevention?", "needed": "Original distribution history, this F-ACP surrogate outcome and direct material outside the scope", "role": "Required", "role_reason": "This production item distinguishes \"Original distribution history, this F-ACP surrogate outcome and direct material outside the scope\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Original distribution history, this F-ACP surrogate outcome and direct material outside the scope\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4: principles for clarifying the question; detailed separation rules are Chamgap's own design; M03 §3.2.1; detailed population conditions are Chamgap's own design; M03 §3.2.2–3.2.3; reverse labeling and test adaptations are Chamgap's own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap's own design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Original distribution history, this F-ACP surrogate outcome and direct material outside the scope\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original domestic distribution/recommendation wording is retained in the complete existing review summary. No new verification of current sales/recommendations, effects of all CPP-ACP/fluoride products or guidance on product selection, use, suitability, prevention or treatment is written.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. New verification of other compositions/populations, long-term caries/daily-life clinical outcomes and current distribution is outside scope or unverified. Review of the existing content remains incomplete.", "missingness": "New verification of other compositions/populations, long-term caries/daily-life clinical outcomes and current distribution is outside scope or unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Original distribution history, this F-ACP surrogate outcome and direct material outside the scope\"" }, { "item_id": "N23", "question_type": "Efficacy comparison and presentation of stored material", "question": "What was actually read from the stored summary, external papers and linked material?", "needed": "Stored summary, PMID38927409 URL and unread registration/plans/COI", "role": "Required", "role_reason": "This production item distinguishes \"Stored summary, PMID38927409 URL and unread registration/plans/COI\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Stored summary, PMID38927409 URL and unread registration/plans/COI\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Stored summary, PMID38927409 URL and unread registration/plans/COI\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The complete stored summary was read for production and labeled 'summary read', with the original URL retained. External papers, registration, plans and COI material remain 'not read'; past review descriptions/bibliography alone do not raise the reading status in this work.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. External access, abstracts/full text, source comparison and external link/click tests were not performed. Review of the existing content remains incomplete.", "missingness": "External access, abstracts/full text, source comparison and external link/click tests were not performed.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Stored summary, PMID38927409 URL and unread registration/plans/COI\"" }, { "item_id": "N24", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are existing Korean/English texts, grade ?/C50, dates, corrections and empty values retained?", "needed": "Selected grade ?/note, parent C50/Good, null/false and 2026-08-26", "role": "Required", "role_reason": "This production item distinguishes \"Selected grade ?/note, parent C50/Good, null/false and 2026-08-26\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Selected grade ?/note, parent C50/Good, null/false and 2026-08-26\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Selected grade ?/note, parent C50/Good, null/false and 2026-08-26\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The complete review summary's Korean/English texts, parent C50/Good, unrecorded precision/false, empty corrections/deliberation and 2026-08-26 are retained. Selected grade ?/note and absent score/status/axes are distinguished from original limitation checks/cross-check history.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. No source/translation review, new verdict/correction or external update was performed in this existing record. Review of the existing content remains incomplete.", "missingness": "No source/translation review, new verdict/correction or external update was performed in this existing record.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Selected grade ?/note, parent C50/Good, null/false and 2026-08-26\"" }, { "item_id": "N25", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are condition preservation, case production and content review distinguished?", "needed": "Condition preservation, freezing, application, case production and incomplete content review", "role": "Required", "role_reason": "This production item distinguishes \"Condition preservation, freezing, application, case production and incomplete content review\" to link materials needed for the selected question with the currently available material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant source material and analysis scope for \"Condition preservation, freezing, application, case production and incomplete content review\" must be available so that unverified matters can be distinguished. This work links wording from the stored summary; review of the existing content remains incomplete.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed follow-up material linking \"Condition preservation, freezing, application, case production and incomplete content review\" as a separate item; no new investigation, calculation or trial is performed in this work.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Condition preservation, freezing, application, case production and content review are separate records. Review of the existing content is incomplete; record counts are not totals of unique clinical trials/participants.", "condition_status": "Partly verified", "status_reason": "Record from the stored summary. Some information is in the stored summary. Review of the existing content is incomplete and clinical source material was not newly verified. Review of the existing content remains incomplete.", "missingness": "Review of the existing content is incomplete and clinical source material was not newly verified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, result tables/plans or user-provided copies for \"Condition preservation, freezing, application, case production and incomplete content review\"" } ], "reports": [ { "report_id": "S01", "title": "Ciribè et al. 2024", "url": "https://pubmed.ncbi.nlm.nih.gov/38927409/", "report_type": "Randomized controlled trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2926-CIRIBE-2024", "independent_replication": null, "observed_result": "The original subclaim note says prevention of incident caries was not measured. Existing ICDAS reductions of .80 versus .39/P=.003, original baseline/final scores and the .41 difference are separate; they are not clinical caries, filling or daily-life outcomes, or 0 incident events. No external funding, unidentified product provision and six-month non-reporting of adverse effects by patients/caregivers are history within the original public review scope; they are not inherited as full-text, COI or safety verification in this work. No new calculations, effects, CIs, grades or independence certification were made.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "A state used when required evidence is confirmed after user review. This production does not declare that review complete.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "User review pending.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 Ciribè2024/PMID38927409 is the same six-month ICDAS trial with 106 randomized and 91 completers (mousse 52/control 39), with original attrition of 14.2%. Existing white-spot scores are distinguished from new caries, filling treatment and patient daily-life outcomes. The same report, people, teeth, lesions, groups, repeated time points and parent/sibling questions are not added as new independent trials/participants. Unique clinical totals are not recorded; record slots are not independent totals." }, "history": [ { "date": "2026-10-10", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public page and data were prepared from the existing 25 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-10" }