Status:
ENROLLING_BY_INVITATION
Investigating the Effect of Chlorine Dioxide and Chlorhexidine Mouthwash on Bad Breath
Lead Sponsor:
Semmelweis University
Conditions:
Halitosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 b...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 18 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06219226
Start Date
April 18 2024
End Date
December 18 2025
Last Update
August 5 2025
Active Locations (1)
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1
Semmelweis University
Budapest, Budapest, Hungary, 1088