A Clinical Study to Evaluate the Efficacy of a Cetylpyridinium Chloride Mouthwash in Improving Gi… (NCT06933368) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Evaluate the Efficacy of a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation
United States136 participantsStarted 2025-04-21
Plain-language summary
The aim of this 12-week clinical study is to evaluate the ability of an experimental mouthwash, containing 0.085 percent (%) Cetylpyridinium chloride (CPC) as an adjunct to toothbrushing with a regular fluoride toothpaste, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste alone in participants with plaque-induced mild to moderate gingivitis.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Participant with at least 20 natural, permanent teeth.
✓. Participant with at least 40 evaluable surfaces for MGI, bleeding index (BI), and TPI.
✓. A participant with plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by a gross visual examination at the screening visit.
✓. A participant with 10% to 30% bleeding sites.
✓. A participant with overall TPI score \>=1.5.
Exclusion criteria
✕. A participant using any antibiotic medication within 4 weeks prior to screening or at any time during the study.
✕. A participant currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition.
✕. A participant currently taking a systemic medication (for example, anti-inflammatory, anticoagulant, immunosuppressants) or traditional/ herbal remedy or as a premedication requirement before an invasive examinations and prophylaxis (for example, knee replacement, Mitral valve prolapse etc.), which, in the opinion of the Investigator, could affect plaque/ gingival condition (for example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).
✕. A participant who has used an antibacterial dentifrice or mouthwash (for example, chlorhexidine) or any oral care product that in the view of the investigator could interfere with plaque formation or measures of gingivitis, within 4 weeks prior to screening.
. A participant who has taken (in the previous 4 weeks), any antibiotics.
✕. A participant who requires the need for antibiotic premedication prior to a dental prophylaxis or taking some blood thinning medication that prohibit the safe conduct of a dental cleaning. Note: Medical consultation may need to be obtained from participant's physician at the examiner's discretion.
✕. A participant who has taken (in the previous 4 weeks) a systemic medication (for example, anti-inflammatory, anti-coagulant, immunosuppressants) or traditional/ herbal remedy as a premedication requirement before an invasive examinations and prophylaxis (for example, knee replacement, Mitral valve prolapse etc.), which, in the opinion of the Investigator, could affect plaque/ gingival condition (for example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).
✕. A participant who has used an antibacterial dentifrice or mouthwash (for example, chlorhexidine) or any oral care product that in the view of the investigator could interfere with plaque formation or measures of gingivitis, in the period between Screening and the Baseline visit.