Halitosis
Conditions
Keywords
ClO2, mouth rinse, malodor
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.
Interventions
PROCEDUREChlorine dioxide mouthwash
This one rinsing will last 2x15 seconds(2x12,5ml).
PROCEDUREChlorhexidine mouthwash
This one rinsing will last 2x15 seconds(2x12,5ml).
Sponsors
Semmelweis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Changes of the volatile sulfur compounds | immediately after the rinse and 3 hours later | with gas chromatography |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Side effects | immediately after the rinse and 3 hours later | (e.g., tooth discoloration, signs of allergic reactions, subjective experiences: unpleasant taste, false taste or burning sensation, pain, changes in salivary flow) |
Countries
Hungary
Outcome results
None listed