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Effect of a Mouthwash Containing Chlorhexidine and Chlorine Dioxide on Halitosis

NCT ID: NCT07265102

Last Updated: 2025-12-22

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-05

Study Completion Date

2024-03-05

Brief Summary

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Halitosis significantly impacts the quality of a patient's life. This randomized, double-blind crossover trial evaluates a mouthwash containing chlorhexidine (0.01%) and chlorine dioxide (0.05%) compared with placebo. Forty participants rinsed twice daily for 2 weeks, followed by a 2-week washout and crossover. The primary outcomes were volatile sulfur compounds (H₂S, CH₃SH), measured by OralChroma. Secondary outcomes included plaque index, gingival index, bleeding on probing, tongue coating, and salivary bacterial counts (Aa, Pg, Fn, Pi, and Ec).

Detailed Description

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Conditions

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Halitosis

Keywords

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halitosis chlorhexidine chlorine dioxide mouthwash volatile sulfur compounds tongue coating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Both mouthwashes were packaged in identical opaque bottles labeled only with numerical codes (1 or 2) by an independent technician who was not involved in data collection or analysis. The two formulations were identical in appearance, color, odor, and taste to maintain blinding. The allocation code was kept confidential and sealed in an envelope until all data had been collected and statistical analyses were completed.

Participants, clinicians, and outcome assessors were blinded to group allocation throughout the trial. Unblinding occurred only after all data analyses were completed.

Study Groups

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CHX-CDO Mouthwash

Participants rinsed with a test mouthwash containing 0.01% chlorhexidine and 0.05% chlorine dioxide. Each participant used 15 mL of the solution twice daily (morning and evening) for 30 seconds over a period of 2 weeks. The mouthwash bottles were identical in appearance to maintain blinding.

Group Type EXPERIMENTAL

CHX 0.01% + CDO 0.05% mouthwash

Intervention Type OTHER

Mouthwash formulation containing chlorhexidine 0.01% and chlorine dioxide 0.05%, prepared by the Department of Pharmacy, University of Medicine and Pharmacy at Ho Chi Minh City.

Placebo Mouthwash

Participants rinsed with a placebo mouthwash containing the same excipients, color, and flavoring agents but without chlorhexidine or chlorine dioxide. Each participant used 15 mL of the placebo solution twice daily for 30 seconds over 2 weeks.

Group Type PLACEBO_COMPARATOR

Placebo mouthwash

Intervention Type OTHER

Identical placebo formulation matched in flavor, color, and excipients but without active ingredients (CHX or CDO).

Interventions

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CHX 0.01% + CDO 0.05% mouthwash

Mouthwash formulation containing chlorhexidine 0.01% and chlorine dioxide 0.05%, prepared by the Department of Pharmacy, University of Medicine and Pharmacy at Ho Chi Minh City.

Intervention Type OTHER

Placebo mouthwash

Identical placebo formulation matched in flavor, color, and excipients but without active ingredients (CHX or CDO).

Intervention Type OTHER

Other Intervention Names

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CHX+ CDO mouthwash Control mouthwash

Eligibility Criteria

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Inclusion Criteria

* ≥20 natural teeth
* H₂S \>1.5 ng/10ml or CH₃SH \>0.5 ng/10ml
* Signed informed consent

Exclusion Criteria

* Systemic disease
* Smoking
* Pregnancy or lactation
* Periodontal pockets ≥4 mm
* Recent antibiotic use (\<1 month)
* Orthodontic appliances or dentures
* Allergy to CHX or C
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role collaborator

Can Tho University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thuy A.V. Pham, Assoc.Prof.

Role: PRINCIPAL_INVESTIGATOR

Can Tho University of Medicine and Pharmacy

Locations

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Odonto-Stomatology Hospital of Ho Chi Minh City

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Vietnam

References

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Pham TAV, Nguyen NTX. Efficacy of chlorine dioxide mouthwash in reducing oral malodor: A 2-week randomized, double-blind, crossover study. Clin Exp Dent Res. 2018 Oct 23;4(5):206-215. doi: 10.1002/cre2.131. eCollection 2018 Oct.

Reference Type BACKGROUND
PMID: 30386642 (View on PubMed)

Shinada K, Ueno M, Konishi C, Takehara S, Yokoyama S, Zaitsu T, Ohnuki M, Wright FA, Kawaguchi Y. Effects of a mouthwash with chlorine dioxide on oral malodor and salivary bacteria: a randomized placebo-controlled 7-day trial. Trials. 2010 Feb 12;11:14. doi: 10.1186/1745-6215-11-14.

Reference Type BACKGROUND
PMID: 20152022 (View on PubMed)

Other Identifiers

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CHXCDO-Halitosis-2022

Identifier Type: -

Identifier Source: org_study_id