Effect of a Mouthwash Containing Chlorhexidine and Chlorine Dioxide on Halitosis

Can Tho University of Medicine and Pharmacy40 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Halitosis

Interventions

CHX 0.01% + CDO 0.05% mouthwashOTHER

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 mouthwashOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Odonto-Stomatology Hospital of Ho Chi Minh City

Ho Chi Minh City, Vietnam

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline, immediate post-rinse, 2 weeks

Secondary Outcomes

Change of plaque index

The Plaque Index (PI) was recorded at four surfaces per tooth (mesiobuccal, buccal, distobuccal, and lingual) to assess plaque accumulation. Each surface was scored on a scale from 0 to 3, where 0 indicates no plaque and 3 indicates abundant plaque accumulation. The mean PI score per participant was calculated at each visit. A lower score indicates less plaque accumulation and improved oral hygiene.

Time frame: At baseline and 2 weeks of mouthwash use

Change in Gingival Index (GI)

The Gingival Index (GI) was evaluated at four surfaces per tooth (mesiobuccal, buccal, distobuccal, and lingual) to assess the degree of gingival inflammation. Each surface was scored on a scale from 0 to 3, where 0 indicates normal gingiva and 3 indicates severe inflammation with marked redness, edema, and a tendency to spontaneous bleeding. The mean GI score per participant was calculated. A lower score reflects healthier gingival conditions.

Time frame: At baseline and 2 weeks of mouthwash use

Change in Bleeding on Probing (BOP)

Data from ClinicalTrials.gov

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