The Anti-inflammatory and Anti-plaque Efficacies of Mouth Rinse Containing Hyaluronic Acid and Hydrogen Peroxide in the Management of Dental Biofilm-induced Gingivitis: a 14 Days Randomized Clinical Trial

748622

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

2023-03-03

2023-04-20

2023-05-01

Completed

Early phase I

54

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '54 subjects with plaque induced gingivitis, caused by accumulation of plaque, will be selected and enrolled in this study. Subsequently, subjects will be equally divided and randomly allocated for three groups, each group received a similar number of subjects (n=18) with a 1:1:1 allocation.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The products will be packaged in such a way that they are not recognizable neither by the operator, nor by the patient. Each package will be assigned a number that in turn will refer to the type of the product. The association between the number and type of the product will be collected by another operator according to the association carried out by a dedicated software. The operator who will deliver the product will be informed about the type only at the end of the treatment.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 54, 'type': 'ACTUAL'}}

2023-10-04