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

NCT06219226 | Enrolling By Invitation DMC

• 1 other identifier: 838
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Halitosis

Keywords

ClO2; mouth rinse; malodor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes of the volatile sulfur compounds

  immediately after the rinse and 3 hours later

• Self-perceived halitosis

  immediately after the rinse and 3 hours later

Other Outcomes (1)

• Side effects

  immediately after the rinse and 3 hours later

Study Arms (2)

Chlorine dioxide mouthwash

EXPERIMENTAL

Participants will rinse once with hyper-pure ClO2 (0.003%) mouthwash.

Procedure: Chlorine dioxide mouthwash

Chlorhexidine mouthwash

ACTIVE COMPARATOR

Participants will rinse once with chlorhexidine-containing mouthwash (0.2%).

Procedure: Chlorhexidine mouthwash

Interventions

Chlorine dioxide mouthwash PROCEDURE

This one rinsing will last 2x15 seconds(2x12,5ml).

Also known as: Solumium Coral®

Chlorine dioxide mouthwash

Chlorhexidine mouthwash PROCEDURE

This one rinsing will last 2x15 seconds(2x12,5ml).

Also known as: Curasept ADS 220, 0.2%

Chlorhexidine mouthwash

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Organoleptic test score (OLS)\>=2 for IOH
• Patients with at least 20 teeth
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University

Budapest, Budapest, 1088, Hungary

Location

Related Publications (4)

• 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.

  PMID: 36634129 BACKGROUND

• 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.

  PMID: 24223899 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.

  PMID: 31825092 BACKGROUND

• 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.

  PMID: 38769314 DERIVED

MeSH Terms

Conditions

Halitosis

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: April 18, 2024
• Primary Completion: December 18, 2025
• Study Completion: December 18, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)