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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorine dioxide mouthwash | Experimental | Participants will rinse once with hyper-pure ClO2 (0.003%) mouthwash. |
|
| Chlorhexidine mouthwash | Active Comparator | Participants will rinse once with chlorhexidine-containing mouthwash (0.2%). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorine dioxide mouthwash | Procedure | This one rinsing will last 2x15 seconds(2x12,5ml). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | immediately after the rinse and 3 hours later |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of the volatile sulfur compounds | with gas chromatography | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | (e.g., tooth discoloration, signs of allergic reactions, subjective experiences: unpleasant taste, false taste or burning sensation, pain, changes in salivary flow) | immediately after the rinse and 3 hours later |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University | Budapest | Budapest | 1088 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36634129 | Background | Szalai E, Tajti P, Szabo B, Hegyi P, Czumbel LM, Shojazadeh S, Varga G, Nemeth O, Keremi B. Daily use of chlorine dioxide effectively treats halitosis: A meta-analysis of randomised controlled trials. PLoS One. 2023 Jan 12;18(1):e0280377. doi: 10.1371/journal.pone.0280377. eCollection 2023. | |
| 24223899 | Background |
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| ID | Term |
|---|---|
| D006209 | Halitosis |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
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| Chlorhexidine mouthwash | Procedure | This one rinsing will last 2x15 seconds(2x12,5ml). |
|
|
| immediately after the rinse and 3 hours later |
| Noszticzius Z, Wittmann M, Kaly-Kullai K, Beregvari Z, Kiss I, Rosivall L, Szegedi J. Chlorine dioxide is a size-selective antimicrobial agent. PLoS One. 2013 Nov 5;8(11):e79157. doi: 10.1371/journal.pone.0079157. eCollection 2013. |
| 31825092 | Background | Kumbargere Nagraj S, Eachempati P, Uma E, Singh VP, Ismail NM, Varghese E. Interventions for managing halitosis. Cochrane Database Syst Rev. 2019 Dec 11;12(12):CD012213. doi: 10.1002/14651858.CD012213.pub2. |
| 38769314 | Derived | Szalai EA, Teutsch B, Babay V, Galvacs A, Hegyi P, Harsfalvi P, Pal R, Varga G, Lohinai ZM, Keremi B. Hyperpure chlorine dioxide versus chlorhexidine in intra-oral halitosis (ODOR trial) - protocol of a double-blinded, double-arm, parallel non-inferiority pilot randomized controlled trial. BDJ Open. 2024 May 20;10(1):35. doi: 10.1038/s41405-024-00221-8. |