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Comparison · NCT03602066-d815462e

Arm I (Chlorine Dioxide Sterilization) vs Arm II (Placebo): Incidence of Severe Oral Mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale Grade 3)

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Arm I (Chlorine Dioxide Sterilization) vs Arm II (Placebo): Incidence of Severe Oral Mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale Grade 3). Trial comparisons, record NCT03602066-d815462e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03602066-d815462e

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 100.00000000000000002780.39wilson
Risk in group 2000.324wilson
Risk difference, group 1 minus group 20-0.3240.39newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treatfrom the risk difference intervalthe two groups' risks are equal

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Arm I (Chlorine Dioxide Sterilization)
Patients receive chlorine dioxide sterilization oral rinse over 30 seconds BID from the start of RT to the evening prior to the 1 month RT follow-up appointment.~Chlorine Dioxide Sterilization: Given via oral rinse
06OG000
Group 2Arm II (Placebo)Patients receive placebo oral rinse over 30 seconds BID from the start of RT to the evening prior to the 1 month RT follow-up appointment.~Placebo: Given via oral rinse08OG001

Outcome

Type
PRIMARY
Title
Incidence of Severe Oral Mucositis (OM) (>= World Health Organization [WHO] Mucositis Scale Grade 3)
Description
Will be compared between arms. Analysis will be performed by estimating the proportion with exact 95% binomial confidence interval for each group separately. Statistical testing will use a chi-square test. As an alternative, Fisher?s Exact Test will be used if the minimum expected value is \< 5.~WHO Scale: Grade 0 (none) - None; Grade I (mild) - Oral soreness, erythema; Grade II (moderate) - Oral erythema, ulcers, solid diet tolerated; Grade III (severe) - Oral ulcers, liquid diet only; Grade IV (life-threatening) - Oral alimentation impossible.~No grade 3 or higher Oral Mucositis was reported on either treatment arm, so no differences were observed.
Time frame
Up to 30 days post radiotherapy
Population

Source ClinicalTrials.gov

Trial

Title
Study Evaluating The Role of ClO2 on Mucositis for Pt. Undergoing Head/Neck Radiotherapy
NCT number
NCT03602066
Phases
PHASE2
Conditions
Head and Neck Carcinoma
Interventions
Chlorine Dioxide Sterilization, Laboratory Biomarker Analysis, Placebo
Lead sponsor
University of Arizona
Results first posted
2024-03-20

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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