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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
60
This one rinsing will last 2x15 seconds(2x12,5ml).
This one rinsing will last 2x15 seconds(2x12,5ml).
Semmelweis University
Budapest, Budapest, Hungary
Changes of the organoleptic testing scores
(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
Changes of the volatile sulfur compounds
with gas chromatography
Time frame: immediately after the rinse and 3 hours later
Self-perceived halitosis
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
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