Trials / Enrolling By Invitation
Enrolling By InvitationNCT06219226
Investigating the Effect of Chlorine Dioxide and Chlorhexidine Mouthwash on Bad Breath
Hyperpure Chlorine Dioxide Versus Chlorhexidine in Intra-oral Halitosis (ODOR Trial)
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Semmelweis University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Chlorine dioxide mouthwash | This one rinsing will last 2x15 seconds(2x12,5ml). |
| PROCEDURE | Chlorhexidine mouthwash | This one rinsing will last 2x15 seconds(2x12,5ml). |
Timeline
- Start date
- 2024-04-18
- Primary completion
- 2025-12-18
- Completion
- 2025-12-18
- First posted
- 2024-01-23
- Last updated
- 2025-08-05
Locations
1 site across 1 country: Hungary
Source: ClinicalTrials.gov record NCT06219226. Inclusion in this directory is not an endorsement.