Clinical trial NCT06219226: Investigating the Effect of Chlorine Dioxide and Chlorhexidine Mouthwash on Bad Breath
Official title: Hyperpure Chlorine Dioxide Versus Chlorhexidine in Intra-oral Halitosis (ODOR Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Halitosis
Keywords: ClO2
mouth rinse
malodor
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes of the organoleptic testing scores
timeFrame: immediately after the rinse and 3 hours later
Secondary outcomes:
measure: Changes of the volatile sulfur compounds
timeFrame: immediately after the rinse and 3 hours later
measure: Self-perceived halitosis
timeFrame: immediately after the rinse and 3 hours later
Other outcomes:
measure: Side effects
timeFrame: immediately after the rinse and 3 hours later
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.