Investigating the Effect of Chlorine Dioxide and Chlorhexidine Mouthwash on Bad Breath

Halitosis Clinical Trial

Official title:

Hyperpure Chlorine Dioxide Versus Chlorhexidine in Intra-oral Halitosis (ODOR Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06219226
• Other study ID #: 838
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 18, 2024
• Est. completion date: December 18, 2025

Study information

• Verified date: January 2024
• Source: Semmelweis University
• Contact: Eszter Szalai, DMD
• Phone: +3614591500
• Email: szalai.eszter[@]semmelweis.hu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 18, 2025
• Est. primary completion date: December 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Halitosis

Intervention

Procedure:
• Chlorine dioxide mouthwash
This one rinsing will last 2x15 seconds(2x12,5ml).
• Chlorhexidine mouthwash
This one rinsing will last 2x15 seconds(2x12,5ml).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	Changes of the volatile sulfur compounds	with gas chromatography	immediately after the rinse and 3 hours later
Secondary	Self-perceived halitosis	with a visual analog scale ratings (0-100, 0 = No Pain, 100 = Worst Possible Pain)	immediately after the rinse and 3 hours later