# Freshly prepared 0.1% nanoparticle curcumin mouthwash × Prevention of oral-mucositis severity during head-and-neck radiotherapy

Verdict 3043 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-09-08  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-24

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

## Assessment scope

- Population: The retained population is adults receiving head-and-neck radiotherapy. Cancer site/stage, age range, baseline oral condition, pre-existing mucositis and eligibility/exclusion criteria remain unverified; scope is not extended to other cancers or conditions.
- Ingredient, formulation and route: The intervention is freshly prepared daily 0.1% mouthwash containing nanoparticle curcumin derived from Curcuma longa, used as an oral rinse and spit. Actual particle, additive, content, batch, preparation/storage and contamination-control material remains unverified; swallowed formulations and other oral gels remain distinct.
- Dose: The retained concentration is 0.1% mouthwash. Volume and frequency are described only as following the trial protocol; exact amounts, frequency, contact time and adherence remain unverified. Daily or optimal doses are not calculated.
- Comparator: The active comparator is 0.15% benzydamine mouthwash. Actual control use, common oral care, radiation dose, concurrent chemotherapy and rescue treatment remain unverified; the comparison is not relabeled as placebo or no treatment.
- Measured outcome: The selected question concerns severe oral mucositis occurrence/severity by WHO criteria. Exact severity thresholds, visit assessments, group events/denominators, between-group effects/CIs and prespecified hierarchy remain unverified. The separate onset HR of approximately 0.5 and onset delay of about 2 weeks are not severe-mucositis prevention effects.
- Duration: The record describes a 6-week comparison during radiotherapy. Rinse initiation, visits, censoring, discontinuation and post-treatment follow-up remain unverified; scope is not extended to long-term efficacy or overall safety.
- Questions outside this scope: The original D/30/Caution and B/P/R1/I2/E0/B2/C0 are retained. Historical verdicts and cross-checking are historical records, not current external original-source verification, reassessment or independent clinical certification.; 74 is the randomized allocation total. Group allocation, mITT/PP analysis, completion, severity and harm denominators remain unverified; the allocation total is not reused for these denominators, and group sizes are not inferred.; The original narrative of no significant difference in the dichotomized severe outcome is retained. Exact group events, between-group effects, CIs and P values remain unverified; no significant difference does not establish equivalence, noninferiority or complete ineffectiveness.; An onset HR of approximately 0.5 and delay of about 2 weeks concern a separate onset outcome. Exact estimates, CIs, analysis counts, timing tables and calculation basis remain unverified; these are not reassigned to WHO-severity benefit or absolute risk reduction.; The retained descriptions of a triple-blind pilot RCT and mITT/PP do not establish verification of actual randomization, blinding, measurement, inclusion/exclusion, adherence or missing-data handling.; CTRI/2018/04/013362 in the citation and the unverified registration field are both retained. Original registration, protocol, SAP and prespecified endpoint/multiplicity plans remain unread; a listed identifier is not promoted to content verification.; The description of academic research and unverified cash-funding/prepared-product roles are retained. Similar short-term tolerability also does not substitute for verification of events, harm denominators, collection, causality, long-term absorption or contamination control.; The original record date 2026-09-08, correction of 1 English field on 2026-09-14 and stored-material authoring date 2026-10-06 remain distinct. Content-review dates are unrecorded; these dates and bibliographic links do not establish current latest searching or full-text reading.

## Checklist items

### N01 · Which mouthwash and mucositis question is presented?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The original question concerns prevention of oral-mucositis severity during head-and-neck radiotherapy. Onset results from the same trial remain separate supportive information.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Review of the independent claim boundary remains unrecorded.
- Required materials and conditions: Intervention, population, severity, time, active comparator and original claim
- Materials to obtain first: Original-trial question, eligibility and endpoint plans
- Further research: Material needed: Original-trial question, eligibility and endpoint plans. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Intervention, population, severity, time, active comparator and original claim must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Intervention, population, severity, time, active comparator and original claim is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N02 · What is the 0.1% nanocurcumin mouthwash?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The record describes freshly prepared daily 0.1% mouthwash.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Particle size, content analyses, additives and actual batch quality remain unverified.
- Required materials and conditions: Curcuma longa-derived curcumin nanoparticles and freshly prepared 0.1% mouthwash
- Materials to obtain first: Formulation composition, nanoparticle characteristics, batch analyses and preparation procedures
- Further research: Material needed: Formulation composition, nanoparticle characteristics, batch analyses and preparation procedures. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Curcuma longa-derived curcumin nanoparticles and freshly prepared 0.1% mouthwash must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Curcuma longa-derived curcumin nanoparticles and freshly prepared 0.1% mouthwash is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N03 · Are rinse-and-spit use and other oral products distinguished?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The route is topical oral rinsing followed by spitting. The original record warns against treating swallowed formulations and topical products as interchangeable.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Actual contact time, swallowed amounts and direct comparisons with gels remain unverified.
- Required materials and conditions: The topical oral rinse-and-spit route
- Materials to obtain first: Rinse-use procedures and exposure records
- Further research: Material needed: Rinse-use procedures and exposure records. This records needed materials; no new research was executed.
- Conditions for verification: Original records on The topical oral rinse-and-spit route must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on The topical oral rinse-and-spit route is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N04 · Which radiotherapy population is included?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The retained population is adults receiving head-and-neck radiotherapy.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Age range, cancer site/stage, baseline mucositis, oral condition and exclusion criteria remain unverified.
- Required materials and conditions: Eligibility and baseline conditions of adults receiving head-and-neck radiotherapy
- Materials to obtain first: Eligibility, baseline-characteristic and radiotherapy-population tables
- Further research: Material needed: Eligibility, baseline-characteristic and radiotherapy-population tables. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Eligibility and baseline conditions of adults receiving head-and-neck radiotherapy must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Eligibility and baseline conditions of adults receiving head-and-neck radiotherapy is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N05 · What were the radiation dose, chemotherapy and oral-care differences?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The original material limits the comparison to treatment during radiotherapy.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Group radiation doses, concurrent chemotherapy, oral hygiene, analgesia and rescue treatment remain unverified.
- Required materials and conditions: Radiotherapy schedules/cumulative doses, concurrent anticancer treatment and basic oral care
- Materials to obtain first: Group cancer-treatment, oral-care and rescue-medication tables
- Further research: Material needed: Group cancer-treatment, oral-care and rescue-medication tables. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Radiotherapy schedules/cumulative doses, concurrent anticancer treatment and basic oral care must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Radiotherapy schedules/cumulative doses, concurrent anticancer treatment and basic oral care is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N06 · What was compared with benzydamine?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The retained direct comparison is 0.1% nanocurcumin versus 0.15% benzydamine for 6 weeks.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Control volume, frequency, contact time and common care remain unverified.
- Required materials and conditions: Actual use of 0.15% benzydamine mouthwash
- Materials to obtain first: Control-use procedures and care common to both groups
- Further research: Material needed: Control-use procedures and care common to both groups. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Actual use of 0.15% benzydamine mouthwash must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Actual use of 0.15% benzydamine mouthwash is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N07 · What were the actual volume and frequency for the 0.1% rinse?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The record describes 0.1% mouthwash, with volume and frequency following the original trial procedures.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Exact mL per use, uses per day, contact time and total dose remain unverified.
- Required materials and conditions: Concentration, volume per 1 rinse, daily frequency and exposure time
- Materials to obtain first: Trial rinse procedures and use diaries
- Further research: Material needed: Trial rinse procedures and use diaries. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Concentration, volume per 1 rinse, daily frequency and exposure time must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Concentration, volume per 1 rinse, daily frequency and exposure time is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N08 · How was quality maintained for freshly prepared daily mouthwash?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The record describes freshly prepared daily nanoparticle mouthwash and limited contamination-control material.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Preparers, sterility/microbiology, storage, stability and test results remain unverified.
- Required materials and conditions: Preparation, storage, expiry, contamination control and quality tracking
- Materials to obtain first: Preparation SOPs, stability and microbial/quality records
- Further research: Material needed: Preparation SOPs, stability and microbial/quality records. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Preparation, storage, expiry, contamination control and quality tracking must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Preparation, storage, expiry, contamination control and quality tracking is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N09 · When during the 6 weeks were treatment and assessments performed?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The retained duration is 6 weeks during radiotherapy.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Rinse initiation, visit schedules, treatment discontinuation and follow-up beyond 6 weeks remain unverified.
- Required materials and conditions: Initiation, radiotherapy schedules, visit assessments and completion/discontinuation
- Materials to obtain first: Trial visit/treatment schedules and follow-up plans
- Further research: Material needed: Trial visit/treatment schedules and follow-up plans. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Initiation, radiotherapy schedules, visit assessments and completion/discontinuation must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Initiation, radiotherapy schedules, visit assessments and completion/discontinuation is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N10 · Are WHO severity and mucositis onset the same outcome?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: WHO oral-mucositis occurrence/severity is the selected question; delayed onset is described as a separate supportive result.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Exact definitions, timepoints and analysis tables for each endpoint remain unverified.
- Required materials and conditions: Distinguishing WHO severity/occurrence from time to onset
- Materials to obtain first: Endpoint definitions, analysis plans and result tables
- Further research: Material needed: Endpoint definitions, analysis plans and result tables. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Distinguishing WHO severity/occurrence from time to onset must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Distinguishing WHO severity/occurrence from time to onset is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N11 · Which WHO grades were dichotomized as severe?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: Severe oral-mucositis occurrence/severity by WHO criteria and a dichotomized severe-outcome comparison are mentioned.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: WHO cutoffs, assessment manuals, visit grades and assessment agreement remain unverified.
- Required materials and conditions: WHO grades, severity cutoff, assessors and repeated measurement
- Materials to obtain first: WHO grading criteria, assessor guidance and visit tables
- Further research: Material needed: WHO grading criteria, assessor guidance and visit tables. This records needed materials; no new research was executed.
- Conditions for verification: Original records on WHO grades, severity cutoff, assessors and repeated measurement must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on WHO grades, severity cutoff, assessors and repeated measurement is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N12 · Which endpoint was prespecified as primary (1st)?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The retained record labels the WHO-severity endpoint as primary.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: The trial prespecified primary (1st) hierarchy and amendments remain unverified because original registration/plans are unread.
- Required materials and conditions: Registration, protocol, SAP and endpoint/analysis hierarchy
- Materials to obtain first: Original CTRI registration, dated plans and SAP
- Further research: Material needed: Original CTRI registration, dated plans and SAP. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Registration, protocol, SAP and endpoint/analysis hierarchy must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Registration, protocol, SAP and endpoint/analysis hierarchy is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N13 · What denominator does 74 represent?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The retained evidence describes 74 randomized participants.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Group allocation counts, mITT/PP analysis counts, completion counts and endpoint denominators remain unverified.
- Required materials and conditions: Distinguishing randomized, group-allocation, analysis and completion denominators
- Materials to obtain first: CONSORT flow and group-allocation/analysis tables
- Further research: Material needed: CONSORT flow and group-allocation/analysis tables. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Distinguishing randomized, group-allocation, analysis and completion denominators must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Distinguishing randomized, group-allocation, analysis and completion denominators is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N14 · Who was included in mITT and what did it estimate?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The design mentions mITT and PP; the retained explanation describes an mITT onset HR signal.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: mITT definitions, exclusion reasons, group denominators and links to severity analyses remain unverified.
- Required materials and conditions: mITT inclusion conditions, exclusions, group counts and target effects
- Materials to obtain first: mITT definitions, flow and endpoint-specific result tables
- Further research: Material needed: mITT definitions, flow and endpoint-specific result tables. This records needed materials; no new research was executed.
- Conditions for verification: Original records on mITT inclusion conditions, exclusions, group counts and target effects must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on mITT inclusion conditions, exclusions, group counts and target effects is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N15 · How did PP results and denominators differ from mITT?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: Only the description that the trial included PP remains in the record.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: PP group counts, adherence conditions, effect estimates and differences from mITT remain unverified.
- Required materials and conditions: PP adherence criteria, denominators and severity/onset results
- Materials to obtain first: PP definitions, analysis and attrition tables
- Further research: Material needed: PP definitions, analysis and attrition tables. This records needed materials; no new research was executed.
- Conditions for verification: Original records on PP adherence criteria, denominators and severity/onset results must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on PP adherence criteria, denominators and severity/onset results is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N16 · What was the between-group result for severe-mucositis prevention?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The original narrative describes no significant difference in the dichotomized severe outcome and no evidence of better severity prevention than benzydamine.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Group event counts, exact effects/RRs/differences, CIs, P values and analysis timepoints remain unverified.
- Required materials and conditions: Severe events/denominators, between-group effects, CIs and timepoints
- Materials to obtain first: WHO-severity result tables and analysis output
- Further research: Material needed: WHO-severity result tables and analysis output. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Severe events/denominators, between-group effects, CIs and timepoints must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Severe events/denominators, between-group effects, CIs and timepoints is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N17 · What do the onset HR of approximately 0.5 and delay of about 2 weeks mean?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The retained result describes delayed onset with an HR of approximately 0.5; the original summary describes onset about 2 weeks later. The mITT onset signal remains distinct from WHO severity.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Exact HRs, CIs, analysis counts, event counts, median onset times and the calculation basis for the 2-week delay remain unverified.
- Required materials and conditions: Definitions, units, denominators and CIs for time-to-onset results
- Materials to obtain first: Onset curves, hazard analyses and timing tables
- Further research: Material needed: Onset curves, hazard analyses and timing tables. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Definitions, units, denominators and CIs for time-to-onset results must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Definitions, units, denominators and CIs for time-to-onset results is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N18 · How were onset assessment intervals, censoring and follow-up handled?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The original material describes a 6-week duration and an onset HR signal.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Visit intervals, censoring rules, event counts, follow-up losses and proportional-hazards assumptions remain unverified.
- Required materials and conditions: Assessment intervals, censoring, event times and radiotherapy exposure
- Materials to obtain first: Onset statistical methods and individual timing/follow-up material
- Further research: Material needed: Onset statistical methods and individual timing/follow-up material. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Assessment intervals, censoring, event times and radiotherapy exposure must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Assessment intervals, censoring, event times and radiotherapy exposure is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N19 · Does no significant difference establish equivalence?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The original record says superiority and equivalence were not established and complete ineffectiveness cannot be concluded.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Equivalence/noninferiority margins, testing designs and relevant CIs remain unverified.
- Required materials and conditions: Superiority/noninferiority/equivalence designs, margins and CIs
- Materials to obtain first: Trial hypotheses, margins and effect intervals
- Further research: Material needed: Trial hypotheses, margins and effect intervals. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Superiority/noninferiority/equivalence designs, margins and CIs must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Superiority/noninferiority/equivalence designs, margins and CIs is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N20 · How were random sequences and allocation concealment implemented?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The retained descriptions identify a pilot RCT and 74 randomized participants.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Sequence generation, allocation ratio, concealment and baseline balance remain unverified.
- Required materials and conditions: Sequence generation, allocation concealment and baseline balance
- Materials to obtain first: Randomization procedures and baseline tables
- Further research: Material needed: Randomization procedures and baseline tables. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Sequence generation, allocation concealment and baseline balance must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Sequence generation, allocation concealment and baseline balance is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N21 · What did triple blinding and blinded WHO assessment cover?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The study title and design describe a triple-blind pilot RCT.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Blinded roles, color/taste, maintenance of blinding, WHO assessors and measurement reliability remain unverified.
- Required materials and conditions: Participant, provider and assessor blinding, and distinguishability of the rinses
- Materials to obtain first: Blinding procedures, product appearance and assessor guidance
- Further research: Material needed: Blinding procedures, product appearance and assessor guidance. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Participant, provider and assessor blinding, and distinguishability of the rinses must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Participant, provider and assessor blinding, and distinguishability of the rinses is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N22 · What were rinse adherence and treatment deviations?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The retained record describes a 6-week rinse comparison and mITT/PP analyses.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Adherence, discontinuation/crossover, rescue treatment and handling of deviations remain unverified.
- Required materials and conditions: Use diaries, nonuse, crossover, radiotherapy interruption and rescue treatment
- Materials to obtain first: Use diaries, discontinuation reasons and analysis plans
- Further research: Material needed: Use diaries, discontinuation reasons and analysis plans. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Use diaries, nonuse, crossover, radiotherapy interruption and rescue treatment must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Use diaries, nonuse, crossover, radiotherapy interruption and rescue treatment is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N23 · Which participants had missing outcome data?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The original record describes 74 randomized participants and an mITT/PP design.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Endpoint missingness, group attrition, reasons and imputation/sensitivity analyses remain unverified.
- Required materials and conditions: Group missingness/attrition, reasons, handling and sensitivity analyses
- Materials to obtain first: Group flow, missing-data handling and sensitivity tables
- Further research: Material needed: Group flow, missing-data handling and sensitivity tables. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Group missingness/attrition, reasons, handling and sensitivity analyses must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Group missingness/attrition, reasons, handling and sensitivity analyses is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N24 · How did registration plans correspond to reported results?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The citation lists CTRI/2018/04/013362, while the original trial-registration field says unverified.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Correspondence remains unverified because original registration, plan versions and result tables are unread.
- Required materials and conditions: CTRI, protocol, SAP and all planned endpoints/analyses
- Materials to obtain first: Registration history, protocol, SAP and complete endpoint tables
- Further research: Material needed: Registration history, protocol, SAP and complete endpoint tables. This records needed materials; no new research was executed.
- Conditions for verification: Original records on CTRI, protocol, SAP and all planned endpoints/analyses must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on CTRI, protocol, SAP and all planned endpoints/analyses is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N25 · What were the interval and clinical importance of the severity difference?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The retained description concerns a small pilot with 74 participants and no significant severity difference.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Effect CIs, prespecified important differences, design sample-size rationale and exact P values remain unverified.
- Required materials and conditions: Exact between-group effects, CIs, importance thresholds and required information
- Materials to obtain first: Between-group effects/CIs and sample-size/importance plans
- Further research: Material needed: Between-group effects/CIs and sample-size/importance plans. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Exact between-group effects, CIs, importance thresholds and required information must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Exact between-group effects, CIs, importance thresholds and required information is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N26 · How were multiple WHO, onset, mITT and PP comparisons planned?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: WHO severity, onset and mITT/PP are mentioned together.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Prespecified comparison lists, multiplicity handling and exploratory/confirmatory distinctions remain unverified.
- Required materials and conditions: Planned analysis counts, hierarchy/adjustment and exploratory labels
- Materials to obtain first: SAP, planned-comparison tables and analysis-specific results
- Further research: Material needed: SAP, planned-comparison tables and analysis-specific results. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Planned analysis counts, hierarchy/adjustment and exploratory labels must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Planned analysis counts, hierarchy/adjustment and exploratory labels is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N27 · How are the paper summary and citation related?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: 1 stored evidence entry and 1 citation point to the Shah et al. 2020 pilot RCT.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: External identity, registration/paper family links and unique-trial/participant totals remain unverified.
- Required materials and conditions: Family links among trial report, citation and registration
- Materials to obtain first: Original paper, registration and reports from the same trial
- Further research: Material needed: Original paper, registration and reports from the same trial. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Family links among trial report, citation and registration must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Family links among trial report, citation and registration is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N28 · What is within scope and what remains unknown?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The original record limits application to the specified formulation, route, dose, duration, population, endpoint and comparator combination.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Direct effects of other mouthwashes, gels, swallowed curcumin, other conditions and periods beyond 6 weeks remain unverified.
- Required materials and conditions: The same mouthwash, cancer-treatment population, 6 weeks, active comparator and severity
- Materials to obtain first: Additional studies of the exact same combination
- Further research: Material needed: Additional studies of the exact same combination. This records needed materials; no new research was executed.
- Conditions for verification: Original records on The same mouthwash, cancer-treatment population, 6 weeks, active comparator and severity must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on The same mouthwash, cancer-treatment population, 6 weeks, active comparator and severity is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N29 · Are PMID, DOI, CTRI and actual reading distinguished?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The original citation lists Shah S et al., Indian J Dent Res. 2020;31:718-727, PMID 33433509, DOI 10.4103/ijdr.IJDR_822_18, CTRI/2018/04/013362. The material actually read is the stored summary.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: External abstract/full text, CTRI and protocol remain unread; external access was not attempted.
- Required materials and conditions: Original citation and actual paper/registration reading status
- Materials to obtain first: Original paper, registration and plans corresponding to the citation
- Further research: Material needed: Original paper, registration and plans corresponding to the citation. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Original citation and actual paper/registration reading status must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Original citation and actual paper/registration reading status is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N30 · What do 2026-09-08 and the correction date mean?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The original record date is 2026-09-08; the English correction date is 2026-09-14.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: No explicit evidence-search cutoff or current external-reading date is recorded.
- Required materials and conditions: Distinguishing the original record date, correction date and current authoring time
- Materials to obtain first: Publication, receipt and reading records for actually provided new evidence
- Further research: Material needed: Publication, receipt and reading records for actually provided new evidence. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Distinguishing the original record date, correction date and current authoring time must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Distinguishing the original record date, correction date and current authoring time is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N31 · How should the English table and historical correction of 1 field be read?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The original English summary describes 74 participants, an onset delay of about 2 weeks and no significant severity difference. Generic descriptions remain in the English evidence table; the historical correction states that 1 field changed.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Original before/after wording identifying the changed field and detailed English-content review remain unrecorded.
- Required materials and conditions: Roles of Korean/English evidence wording and the historical correction
- Materials to obtain first: Complete before/after originals and specific English result tables
- Further research: Material needed: Complete before/after originals and specific English result tables. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Roles of Korean/English evidence wording and the historical correction must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Roles of Korean/English evidence wording and the historical correction is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N32 · How does the original D/30 verdict differ from current material review?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The original D/30/Caution verdict is retained as historical information. Historical verification wording does not establish current external original-source reading or completed content review.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Completed current content review or external clinical validation is not recorded.
- Required materials and conditions: Roles of the original grade, score, caution label and historical verdict
- Materials to obtain first: Original verdict and subsequently provided correction events
- Further research: Material needed: Original verdict and subsequently provided correction events. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Roles of the original grade, score, caution label and historical verdict must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Roles of the original grade, score, caution label and historical verdict is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N33 · What were cash funding, prepared-product support and author interests?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The record describes academic research, with details of cash funding and prepared-product roles unverified.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Amounts, prepared-product support, employee authorship and original conflict-of-interest declarations remain unverified.
- Required materials and conditions: Cash/product support, affiliations, conflicts of interest and reporting roles
- Materials to obtain first: Funding/COI declarations, author affiliations and product-support descriptions
- Further research: Material needed: Funding/COI declarations, author affiliations and product-support descriptions. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Cash/product support, affiliations, conflicts of interest and reporting roles must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Cash/product support, affiliations, conflicts of interest and reporting roles is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N34 · Which events and denominators underlie short-term tolerability?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The original safety wording describes similar short-term tolerability in a small trial.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Event types, group event/person counts, harm denominators, collection methods and attrition remain unverified.
- Required materials and conditions: Event definitions, collection, group events/denominators, discontinuation and missingness
- Materials to obtain first: Group adverse-event/discontinuation and harm-collection tables
- Further research: Material needed: Group adverse-event/discontinuation and harm-collection tables. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Event definitions, collection, group events/denominators, discontinuation and missingness must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Event definitions, collection, group events/denominators, discontinuation and missingness is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N35 · How are harm timing, radiotherapy and concurrent exposures distinguished?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The original material describes topical rinsing during radiotherapy and 6-week short-term tolerability.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Individual-event timing, improvement after withdrawal/re-exposure, concomitant medicines and underlying-condition alternatives remain unverified.
- Required materials and conditions: Onset, recovery, withdrawal/re-exposure, cancer treatment and other causes
- Materials to obtain first: Individual-event timelines, concomitant medicines and original harm material
- Further research: Material needed: Individual-event timelines, concomitant medicines and original harm material. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Onset, recovery, withdrawal/re-exposure, cancer treatment and other causes must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Onset, recovery, withdrawal/re-exposure, cancer treatment and other causes is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N36 · What is known about safety beyond the short trial?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The record describes limited long-term safety, absorption and contamination-control material for freshly prepared nanoparticle mouthwash.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Long-term exposure, absorbed amounts, rare events, vulnerable populations and preparation-quality harm material remain unverified.
- Required materials and conditions: Long-term/rare harms, local/systemic absorption, preparation contamination and vulnerable groups
- Materials to obtain first: Absorption/long-term follow-up, quality/contamination and vulnerable-population material
- Further research: Material needed: Absorption/long-term follow-up, quality/contamination and vulnerable-population material. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Long-term/rare harms, local/systemic absorption, preparation contamination and vulnerable groups must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Long-term/rare harms, local/systemic absorption, preparation contamination and vulnerable groups is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N37 · Were the same formulation, severity outcome or harms repeated elsewhere?

Verification status: Unverified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The stored record contains 1 trial summary and 1 citation. Other oral gels or general curcumin benefits are not treated as replication of this question.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Independent replication of severity findings for the same rinse, independent harm cases and unique-trial counts remain unverified.
- Required materials and conditions: Other teams/unique trials, formulation/endpoint matching, report families and harm events
- Materials to obtain first: Additional original reports with the same formulation, population, comparison and endpoint
- Further research: Material needed: Additional original reports with the same formulation, population, comparison and endpoint. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Other teams/unique trials, formulation/endpoint matching, report families and harm events must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Other teams/unique trials, formulation/endpoint matching, report families and harm events is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

### N38 · How are the summary actually read and unread original materials distinguished?

Verification status: Partly verified  
Reading scope: The retained Korean and English summaries and bibliography were read. External papers, abstracts/full texts, registration, protocols, analysis plans, result tables and support disclosures remain unread, with no access attempt.

- Current findings: The stored summary is the material read. The original PubMed citation URL is linked; external materials remain unread and external access was not attempted.
- Why unverified: Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.
- Reason for missing information: Full text, registration, plans and additional materials have not been acquired/read; existing content review remains incomplete.
- Required materials and conditions: Stored summary, external paper/registration/plans/quality/harms slots and update events
- Materials to obtain first: Original or correction material provided or separately authorized by the user
- Further research: Material needed: Original or correction material provided or separately authorized by the user. This records needed materials; no new research was executed.
- Conditions for verification: Original records on Stored summary, external paper/registration/plans/quality/harms slots and update events must link to formulation, actual use, population, comparison, WHO severity/onset, analyses, denominators and timepoints, distinguishing stored information from what remains unverified.
- Why this condition is needed: Material on Stored summary, external paper/registration/plans/quality/harms slots and update events is needed to connect the relevant mouthwash, radiotherapy population, active comparator, selected severity outcome, separate onset outcome, analysis denominator or harm scope.
- Application exceptions: Mouthwash remains distinct from swallowed formulations and gels for other oral conditions; delayed onset is not relabeled as prevention of severe mucositis. Doses are not calculated from concentrations, and allocation totals are not reused as group, analysis or harm denominators. No significant difference does not establish equivalence, noninferiority or complete ineffectiveness.
- Remaining uncertainty: Gaps remain in actual composition, use, cancer treatment, oral care, measurement, prespecified endpoints, mITT/PP, between-group effects/intervals, missingness, support and harms. Original verdicts and historical verification wording do not constitute current external original-source reading or new clinical certification.
- Referenced methods: Existing principles distinguish formulation, concentration, preparation, topical route, population, concurrent treatment, active comparator, WHO severity, onset, analysis denominators, support and harms in the retained mouthwash-trial record.
- Related sources: R01

## Evidence and sources

### R01

2020 · Report of a nanocurcumin mouthwash trial for radiation oral mucositis

[PubMed](https://pubmed.ncbi.nlm.nih.gov/33433509/)

Materials actually read: Stored existing review summary read for preparation; external abstract/full text and registration unread, with external access not attempted  
Findings recorded in the summary: Onset delayed with an HR of approximately 0.5; no significant difference in the dichotomized severe outcome  
Record level: These are original narratives about selected WHO severity and a separate onset outcome. Exact severity effects, CIs and denominators remain unverified; the onset signal is not relabeled as prevention of severe mucositis.  
Independent replication: This record links a trial-report summary and original citation; material slots are not counted as independent trials. The 74 randomized participants remain distinct from unique-participant totals and endpoint analysis denominators; unique-trial counts, unique-participant totals and independent replication remain unverified.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored existing review summary | Existing stored summary acquired | Stored summary | Stored summary read | This is the stored summary actually read; it does not establish full-paper reading. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates. |
| External paper identity link | Original bibliography link only; external content unread | Unread; no access attempt | Unread | The original PubMed citation URL is linked. External page contents, abstract and full text remain unread. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates. |
| External full paper | Original bibliography link only; external content unread | Unread; no access attempt | Unread | This is the original paper bibliographic link; it does not establish full-text acquisition, download or reading. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates. |
| Registration material | Needed material; existence and public availability unverified | Unread; no access attempt | Unread | CTRI/2018/04/013362 appears in the original citation, but the registration URL, contents and plan history remain unverified. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates. |
| Protocol and analysis plan | Needed material; existence and public availability unverified | Unread; no access attempt | Unread | Protocol, SAP and prespecified endpoint/analysis plans remain unread; existence and public availability of separate materials also remain unverified. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates. |
| Group flow, analysis and result tables | Needed material; existence and public availability unverified | Unread; no access attempt | Unread | 74 is the allocation denominator; group flow, mITT/PP, WHO/onset result tables and actual analysis denominators remain unverified. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates. |
| Mouthwash formulation, preparation and use material | Needed material; existence and public availability unverified | Unread; no access attempt | Unread | The descriptions of 0.1% concentration and fresh preparation are retained. Composition, actual volume/frequency, quality and public availability/acquisition of additional documents remain unverified. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates. |
| Harm, absorption, long-term and quality material | Needed material; existence and public availability unverified | Unread; no access attempt | Unread | Short-term tolerability wording is not relabeled as absence of events or overall safety. Harm counts, absorption, long-term follow-up and contamination-control material remain unread. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates. |
| Funding, product-support and conflict-of-interest material | Needed material; existence and public availability unverified | Unread; no access attempt | Unread | The academic-setting description and unverified cash/prepared-product roles are retained; original support and conflict-of-interest disclosures remain unread. This links the stored summary and original citation. External paper/registration identity, contents, report families and independent replication remain separately unverified; it does not establish current original-source reading. Material dates refer to the retained record date. They are not actual external reading or completed latest-search dates; authoring timestamps also remain distinct from completed content-review dates. |

## Review criteria and methods

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

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

## What the statuses mean

- Partly verified: Partial information from the stored summary is linked; detailed originals and content review remain incomplete.
- Unverified: Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.
- Review incomplete: Review of existing content remains incomplete.
- Met: This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.
- Not reported: Unreported within material actually read. Unread external material is not relabeled as unreported.
- Inaccessible: This means actual access failure. External access was not attempted in this work, so this state was not assigned.
- Not applicable: Used only with an application exception and reason based on the question scope.
- Conflicting data: This requires actual comparison of materials; no new conflict judgment was made in this work.
- Insufficient evidence for the conditions: This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade.

## Change history

2026-10-24 · Public page/materials 1.0. The public view and materials were prepared from the existing 38 items. No new clinical search, verification-state change or scoring was performed.