drugset / Trial / NCT05787600

Anti-inflammatory and Anti-plaque Efficacies of Mouth Rinse Containing Hyaluronic Acid and Hydrogen Peroxide

NCT05787600

Phase 3 Completed 54 enrolled University of Baghdad
RandomizedParallel-groupDouble-blindTreatment

Summary

The goal of this clinical trial is to test efficiency of using mouth rinse containing (H2O2 and HA) over a period of two weeks to control on gingival inflammation and plaque accumulation through measuring the clinical periodontal parameters (Gingival Index (GI), Bleeding on probing (BOP) and modified Quigley-Hein Plaque Index (mQHPI ) in comparison with Chlorhexidine (CHX) and placebo mouth rinses in patients with biofilm induced gingivitis. Objectives: * Evaluate the clinical efficiency of using mouth rinse containing (H2O2 and HA) over a period of 14 days to control on gingival inflammation and plaque accumulation through measuring the clinical periodontal parameters (Gingival Index, Bleeding on probing and modified Quigley-Hein Plaque Index in comparison with Chlorhexidine and placebo mouth rinses in patients with biofilm induced gingivitis. * Measuring levels of salivary cytokines, Interleukin 1 beta (IL-1B) and Interleukin 6 (IL-6) at baseline visit before using mouth rinse and after 14 days of using the mouth rinse containing H2O2 and HA compared to chlorhexidine and placebo mouth rinses. * Evaluate subjects' perception of a mouth rinse (H2O2 and HA), CHX and placebo mouth rinses after 14 days from using three mouth rinse

Timeline

Start
2023-03-03
Primary completion
2023-04-20
Completion
2023-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject BMG0703 Unknown 10 ml Other
Comparator Chlorhexidine Small molecule 0.12 % Other
Comparator Chlorhexidine Small molecule 10 ml Other

Indications