Effect of a Mouthwash Containing Chlorhexidine and Chlorine Dioxide on Halitosis (CHX+CDO)

Can Tho University of Medicine and Pharmacy

Status: Completed

Conditions: Halitosis

Treatments: Other: CHX 0.01% + CDO 0.05% mouthwash; Other: Placebo mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT07265102

CHXCDO-Halitosis-2022

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

CHX-CDO Mouthwash

Experimental group

Description:

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.

Treatment:

Other: CHX 0.01% + CDO 0.05% mouthwash

Placebo Mouthwash

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo mouthwash