Odonto-Stomatology Hospital of Ho Chi Minh City
Ho Chi Minh City, 70000, Vietnam
NCT Number: NCT07265102
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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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Ho Chi Minh City, 70000, Vietnam
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Identical placebo formulation matched in flavor, color, and excipients but without active ingredients (CHX or CDO).
Other names: Control mouthwash
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.
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.
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.
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.
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.
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.
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.
Can Tho University of Medicine and Pharmacy
Other
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
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