Effect of a Mouthwash Containing Chlorhexidine and Chlorine Dioxide on Halitosis

NCT07265102 | Completed

• 1 other identifier: CHXCDO-Halitosis-2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Halitosis

Keywords

halitosis; chlorhexidine; chlorine dioxide; mouthwash; volatile sulfur compounds; tongue coating

Outcome Measures

Primary Outcomes (2)

• Change in Hydrogen sulfide (H₂S) concentration in breath

  The concentration of hydrogen sulfide (H₂S) in oral breath was measured using the OralChroma™ device. The difference between baseline, immediately after rinsing, and 2 weeks was used to assess the efficacy of the mouthwash in reducing volatile sulfur compounds.

  baseline, immediate post-rinse, 2 weeks

• Change in Methyl mercaptan (CH₃SH) concentration in breath

  The concentration of methyl mercaptan (CH₃SH) in oral breath was measured using the OralChroma™ device. The difference between baseline, immediately after rinsing, and 2 weeks was used to evaluate the short-term and sustained effects of the mouthwash on halitosis.

  Baseline, immediate post-rinse, 2 weeks

Secondary Outcomes (5)

• Change of plaque index

  At baseline and 2 weeks of mouthwash use

• Change in Gingival Index (GI)

  At baseline and 2 weeks of mouthwash use

• Change in Bleeding on Probing (BOP)

  At baseline and 2 weeks of mouthwash use

• Change in Tongue Coating Index

  At baseline and 2 weeks of mouthwash use

• Change in salivary bacterial load (qPCR quantification)

  At baseline and 2 weeks of mouthwash use

Study Arms (2)

CHX-CDO Mouthwash

EXPERIMENTAL

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.

Other: CHX 0.01% + CDO 0.05% mouthwash

Placebo Mouthwash

PLACEBO COMPARATOR

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.

Other: Placebo mouthwash

Interventions

CHX 0.01% + CDO 0.05% mouthwash 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.

Also known as: CHX+ CDO mouthwash

CHX-CDO Mouthwash

Placebo mouthwash OTHER

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

Also known as: Control mouthwash

Placebo Mouthwash

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: collaborator
• Can Tho University of Medicine and Pharmacy: lead

Study Sites (1)

Odonto-Stomatology Hospital of Ho Chi Minh City

Ho Chi Minh City, 70000, Vietnam

Location

Related Publications (2)

• 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.

  PMID: 30386642 BACKGROUND

• 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.

  PMID: 20152022 BACKGROUND

MeSH Terms

Conditions

Halitosis

Interventions

Cysteine Dioxygenase; Mouthwashes

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dioxygenases; Oxygenases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Thuy A.V. Pham, Assoc.Prof.

  Can Tho University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: September 5, 2023
• Primary Completion: December 5, 2023
• Study Completion: March 5, 2024
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within 6 months after publication, available for 3 years
• Access Criteria: Researchers with IRB-approved proposals may request access via corresponding author.

Locations

VN (1)