Investigating the Effect of Chlorine Dioxide and Chlorhexidine Mouthwash on Bad Breath

Not Applicable

Not yet recruiting

• Conditions: Halitosis

• Registration Number: NCT06219226
• Lead Sponsor: Semmelweis University

Brief Summary

The ODOR trial will be a single-centric, double-blinded, parallel-group, double-armed pilot randomized controlled trial with a non-inferiority design. The efficacy of hyperpure chlorine dioxide will be compared to chlorhexidine mouthwash. The short-term effect of the mouthwashes will be investigated in a 3-hour-long period. The primary endpoint will be the changes in the organoleptic testing scores.

Detailed Description

Eligible patients will be randomly allocated to two groups in a 1:1 ratio. Necessary data will be collected with prespecified electronic case report forms (REDCap). The statistician will calculate the sample size at the end of the pilot investigation of the first 30-30 patients. If feasible, investigators will continue the study by enrolling more patients.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-12
• Study Start: 2024-01-18
• Study First Posted: 2024-01-23
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-26
• Primary Completion: 2025-12-18
• Study Completion: 2025-12-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Organoleptic test score (OLS)>=2 for IOH
• Patients with at least 20 teeth
• 8 hours of scented oral hygiene product usage, 4 hours of eating, and 2 hours of drinking restriction
• on the day of investigation, restriction of alcohol, caffeine, perfume usage, and food intake with characteristic smell

Exclusion Criteria

• Medical history of systematic and infectious diseases (e.g., hepatitis, HIV, tuberculosis).
• Antibiotic use within the month before the study's start or during the trial or any regular medication
• Extraoral halitosis (will be distinguished by observing the nasal breath)
• Eat foods (like garlic) linked to oral malodor on the day before and the sampling day, as well as wear heavily fragrant cosmetics on that day.
• Patients with removable dentures
• Smokers (Cigars, Cigarettes, Pipes, Chewing tobacco, e-cigarette, or vaping products used in the last month)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes of the organoleptic testing scores	immediately after the rinse and 3 hours later	(gold standard 6-point (0-5) intensity scale. The examiner rates it 0 when the patient has no halitosis, and 5 when it is very severe)

Secondary Outcome Measures

Name	Time	Method
Self-perceived halitosis	immediately after the rinse and 3 hours later	with a visual analog scale ratings (0-100, 0 = No Pain, 100 = Worst Possible Pain)
Changes of the volatile sulfur compounds	immediately after the rinse and 3 hours later	with gas chromatography