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Completed

NCT Number: NCT07265102

Effect of a Mouthwash Containing Chlorhexidine and Chlorine Dioxide on Halitosis

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odonto-Stomatology Hospital of Ho Chi Minh City

Ho Chi Minh City, 70000, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: CHX+ CDO mouthwash

Placebo Mouthwash

Other

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

Other names: Control mouthwash

Primary outcomes

  1. Change in Hydrogen sulfide (H₂S) concentration in breath

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

    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.

  2. Change in Methyl mercaptan (CH₃SH) concentration in breath

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

    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.

Secondary outcomes

  1. Change of plaque index

    Time frame: At baseline and 2 weeks of mouthwash use

    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.

  2. Change in Gingival Index (GI)

    Time frame: At baseline and 2 weeks of mouthwash use

    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.

  3. Change in Bleeding on Probing (BOP)

    Time frame: At baseline and 2 weeks of mouthwash use

    The percentage of sites showing bleeding upon gentle probing was recorded as an indicator of gingival inflammation and bleeding tendency. The presence of bleeding was recorded at each examined site following gentle periodontal probing. BOP was expressed as the percentage of bleeding sites, calculated as the number of sites showing bleeding divided by the total number of sites examined ×100%. Higher percentages indicate greater gingival inflammation.

  4. Change in Tongue Coating Index

    Time frame: At baseline and 2 weeks of mouthwash use

    The tongue dorsum was visually divided into six areas (three anterior and three posterior) according to Winkel's Tongue Coating Index (WTCI). Each area was scored from 0 (no coating), 1 (mild coating), and 2 (thick coating), and the total score (0-12) was calculated as the Tongue Coating Index.

  5. Change in salivary bacterial load (qPCR quantification)

    Time frame: At baseline and 2 weeks of mouthwash use

    Salivary bacterial counts of Porphyromonas gingivalis, Fusobacterium nucleatum, Prevotella intermedia, Eikenella corrodens, and Aggregatibacter actinomycetemcomitans were quantified using real-time PCR (qPCR). Changes in bacterial load (log CFU/mL) between baseline and 2 weeks were compared to assess the antibacterial effect of the mouthwash.

Sponsors and collaborators

Lead sponsor

Can Tho University of Medicine and Pharmacy

Other

Collaborators

  • University of Medicine and Pharmacy at Ho Chi Minh City

Registry information

Official study title

A Randomized Double-Blind Crossover Clinical Trial Evaluating the Efficacy of a Mouthwash Containing Chlorhexidine and Chlorine Dioxide in Patients With Oral Malodor

Acronym: CHX+CDO

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Dec 4, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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