An interventional study of CHX 0.01% + CDO 0.05% mouthwash and Placebo mouthwash in Halitosis, sponsored by Can Tho University of Medicine and Pharmacy. Completed at 1 site in Vietnam. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Can Tho University of Medicine and Pharmacy · Not applicable, Interventional, and Treatment
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).
93 studies on the registry are indexed under Halitosis; 17 are open to participants now.
This study's enrollment of 40 is below the median of 45 across 79 interventional studies indexed under Halitosis.
Browse Halitosis studies →Can Tho University of Medicine and Pharmacy is the lead sponsor of 35 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Identical placebo formulation matched in flavor, color, and excipients but without active ingredients (CHX or CDO).
Also known as: Control mouthwash
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
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)
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
Change in Tongue Coating Index
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
Change in salivary bacterial load (qPCR quantification)
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.
Time frame: At baseline and 2 weeks of mouthwash use
Plan to share: Yes — De-identified data, study protocol, and statistical code will be available upon reasonable request
Supporting information: Study protocol, Statistical analysis plan
Time frame: Within 6 months after publication, available for 3 years
Access criteria: Researchers with IRB-approved proposals may request access via corresponding author.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Can Tho University of Medicine and Pharmacy