drugset / Trial / NCT07031388

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

NCT07031388

Completed 80 enrolled Ramziyah Hayder Bakr
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-07-01
Primary completion
2025-09-01
Completion
2025-10-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorhexidine Small molecule 0.12 % Oral
Subject Hyaluronic Acid Other / unclassified 0.1 % Oral
Subject Hyaluronic Acid Other / unclassified 0.12 % Oral
Subject Hydrogen Peroxide Small molecule 1.8 % Oral

Indications