Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06219226

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University

Budapest, 1088, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Chlorine dioxide mouthwash

Procedure

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

Other names: Solumium Coral®

Chlorhexidine mouthwash

Procedure

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

Other names: Curasept ADS 220, 0.2%

Primary outcomes

  1. Changes of the organoleptic testing scores

    Time frame: immediately after the rinse and 3 hours later

    (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)

Secondary outcomes

  1. Changes of the volatile sulfur compounds

    Time frame: immediately after the rinse and 3 hours later

    with gas chromatography

  2. Self-perceived halitosis

    Time frame: immediately after the rinse and 3 hours later

    with a visual analog scale ratings (0-100, 0 = No Pain, 100 = Worst Possible Pain)

Other outcomes

  1. Side effects

    Time frame: immediately after the rinse and 3 hours later

    (e.g., tooth discoloration, signs of allergic reactions, subjective experiences: unpleasant taste, false taste or burning sensation, pain, changes in salivary flow)

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2024
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.