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

January 24, 2024 updated by: Eszter Á Szalai, DMD, Semmelweis University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chlorine dioxide mouthwash
Participants will rinse once with hyper-pure ClO2 (0.003%) mouthwash.
Procedure: Chlorine dioxide mouthwash
This one rinsing will last 2x15 seconds(2x12,5ml).
Other Names:
  • Solumium Coral®
Active Comparator: Chlorhexidine mouthwash
Participants will rinse once with chlorhexidine-containing mouthwash (0.2%).
Procedure: Chlorhexidine mouthwash
This one rinsing will last 2x15 seconds(2x12,5ml).
Other Names:
  • Curasept ADS 220, 0.2%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
immediately after the rinse and 3 hours later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of the volatile sulfur compounds
Time Frame: immediately after the rinse and 3 hours later
with gas chromatography
immediately after the rinse and 3 hours later
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)
immediately after the rinse and 3 hours later

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
immediately after the rinse and 3 hours later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 18, 2024

Primary Completion (Estimated)

December 18, 2025

Study Completion (Estimated)

December 18, 2025

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 12, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 838

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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