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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-18

Study Completion Date

2025-12-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Halitosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Chlorine dioxide mouthwash

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

Group Type EXPERIMENTAL

Chlorine dioxide mouthwash

Intervention Type PROCEDURE

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

Chlorhexidine mouthwash

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

Group Type ACTIVE_COMPARATOR

Chlorhexidine mouthwash

Intervention Type PROCEDURE

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

Interventions

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Chlorine dioxide mouthwash

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

Intervention Type PROCEDURE

Chlorhexidine mouthwash

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

Intervention Type PROCEDURE

Other Intervention Names

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Solumium Coral® Curasept ADS 220, 0.2%

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No