Semmelweis University
Budapest, 1088, Hungary
NCT Number: NCT06219226
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Budapest, 1088, Hungary
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This one rinsing will last 2x15 seconds(2x12,5ml).
Other names: Solumium Coral®
This one rinsing will last 2x15 seconds(2x12,5ml).
Other names: Curasept ADS 220, 0.2%
Time frame: 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)
Time frame: immediately after the rinse and 3 hours later
with gas chromatography
Time frame: immediately after the rinse and 3 hours later
with a visual analog scale ratings (0-100, 0 = No Pain, 100 = Worst Possible Pain)
Time frame: 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)
Semmelweis University
Other
Hyperpure Chlorine Dioxide Versus Chlorhexidine in Intra-oral Halitosis (ODOR Trial)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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