Clinical Trial

Mouthwashes for Gingivitis: Comparing a Hydrogen Peroxide-Hyaluronic Acid Mix, Hyaluronic Acid, and Chlorhexidine, A Triple-Blind Clinical Trial

Study acronym: TRIPLE-G
Completed
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Summary
This randomized, triple-blind clinical trial is designed to evaluate the efficacy of four different mouthwash formulations - hydrogen peroxide with hyaluronic acid, hyaluronic acid alone, chlorhexidine, and placebo - in four parallel arms. The study will take place at multiple centers, starting on June 1, 2025, and is expected to conclude by October 1, 2026. There is no external funding source for this study. Eligible participants include systemically healthy individuals aged 18 to 35 years with a gingival and plaque index score of 1 or higher. Individuals with systemic or oral diseases will be excluded. Participants will be randomly assigned to one of four groups, each receiving a different mouthwash formulation for twice-daily use, following standardized oral hygiene instructions. The potential benefit includes a reduced risk of gingivitis progression to periodontitis. There are no significant anticipated risks, though mild oral discomfort or taste alteration may occur.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-06-18; most recent amendment 2026-04-22.
Status change: Active, Not Recruiting → Completed 2026-04-22
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-08-27
Trial Details
NCT Number NCT07031388
Lead Sponsor Ramziyah Hayder Bakr
Conditions Plaque Induced Gingival Disease
Enrollment 80 participants
Start Date 2025-07-01
Primary Completion 2025-09-01 (estimated)
Study Completion 2025-10-17 (estimated)
Updated on ClinicalTrials.gov 2026-04-23