CompletedPhase 3

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

Iraq54 participantsStarted 2023-03-03

Plain-language 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

Who can participate

Age range18 Years – 70 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: * Subjects aged ≥ 18 years-old. * participants who were apparently systemically healthy. * Presence of ≥ 20 teeth. * Patients with generalized gingivitis (having \>30% bleeding sites with no PPD \>3 mm, intact periodontium and no loss of periodontal attachment . * Patients without presence of supra- or subgingival calculus Exclusion Criteria: * Patients who refuse to write an informed consent form. * Extensive untreated dental caries and diseases of hard and soft palate. * Those having periodontitis. * Ongoing orthodontic treatment. * History of antibiotics intake within the past 3 months. * Pregnant or intended to and lactating mother. * Smoker or alcoholism * Using mouthwash within past one month. * Those with a recent tooth extraction. * Those having a history of hypersensitivity to any product used in the present study.

What they're measuring

Change in Gingival index

Timeframe: 0, 14 days

Trial details

NCT IDNCT05787600

SponsorUniversity of Baghdad

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-20