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

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Investigate and compare the association of salivary concentration of IL-1B and IL-6 in periodontal health and generalized gingivitis.

• Evaluate the correlation between clinical periodontal parameters and salivary (IL-1B and IL-6)

• Evaluate subjects' perception of a mouth rinse (H2O2 and HA), CHX and placebo mouth rinses after 14 days from using three mouth rinse

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Baghdad
• Treatments: Chlorhexidine; Chlorhexidine gluconate

Criteria

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.