Anti-inflammatory and Anti-plaque Efficacies of Mouth Rinse Containing Hyaluronic Acid and Hydrogen Peroxide
Condition: Plaque Induced Gingivitis; Mouth Diseases; Bleeding Gum; Periodontal Diseases
MeSH terms: Gingivitis; Periodontal Diseases; Mouth Diseases
Study type: Interventional
Phase: Phase 3

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
    

Detailed description: 
      54 subjects will be enrolled, who show with generalized gingivitis (having >30% bleeding
      sites with no PPD >3 mm, intact periodontium and no loss of periodontal attachment), caused
      by accumulation of plaque.

      A double-blind, randomized parallel 3-arms clinical trial include using the following mouth
      rinses, 0.12% CHX (KIN Gingival, KIN, Barcelona, Spain) as positive-control , distilled water
      (placebo, nonactive control) with food additives (to blind the subjects and examiner) and
      Perhyal rinse (BMG Pharma, Milan, Italy ) containing has H2O2 (1,80%) and HA (0,10%) with the
      remaining part being water (97,3%) and inert additives as active ingredients, will be used as
      test interventions. The mouthwashes will be contained in identical opaque bottles that were
      randomly given sequential letters codes (A, B and C ) by a another subject who will not
      involved in the clinical investigation. This ensured the double blindness of both the
      participant and examiner during the clinical trial. Decoding will performed after the end of
      the study.

      Randomization will be performed by the examiner for enrollment patient in 3 groups. Each
      group will be assigned a letter (A, B or C) corresponding to the intervention used. Random
      numbers were generated and used to re-sort the order of the groups and participants (n=54),
      who will distributing into designated groups, each group received a similar number of
      subjects (n=18) with a 1:1:1 allocation, by using a Microsoft Excel random table (Microsoft
      Office 2016, Microsoft Corporation, USA). Then, coded bottles with the interventions will be
      delivered to the participants together with instructions for use. The participants will be
      asked to rinse with 10 ml of undiluted.

      mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to
      refrain from eating and drinking for 30 min after rinsing. Discontinuation of the mouthwash
      will be advised in cases of any allergic reaction. All participants will be received a
      toothbrush with medium-hardness bristles and a toothpaste (COLGATE®, Colgate-Palmolive, NY,
      USA). No modifications to the participants' tooth brushing technique will be permitted.

      In baseline visit at the beginning,

      Saliva collection for IL-1β and IL-6 measurement then clinical periodontal parameters
      examination starting with gingival index (Loe and Silness in 1963) designed to assess the
      severity and quality of gingival inflammation in an individual or population. The gingival
      inflammation is assessed on the basis of color, consistency and bleeding on probing. A
      periodontal probe will be runned along the gingival margin. The gingiva surrounding the tooth
      is assessed at four sites: mesio-facial papilla, facial marginal gingiva, disto-facial
      papilla and lingual marginal gingiva.

      Followed by dryness and wait then measurement of BOP for the six surfaces of all teeth except
      wisdom teeth through gently inserting the periodontal probe to the depth of the gingival
      sulcus then removed coronally and waited for 30 s to observe the presence of bleeding (0=no
      bleeding, 1=presence of bleeding)

      Then finally followed by the Modified Quigley Hein Plaque Index with Fluorescein disclosing
      tablets. In the (mQHPI) the data had been recorded from labial/buccal and lingual/palatal
      surfaces of each disclosed tooth except wisdom teeth and any teeth had filling surface.

      The distance from the gingival margin to the edge of the disclosed area measured to the
      nearest 0.5 mm using a calibrated periodontal probe and the scores registered according to
      record form of mQHPI for each participant. The mean of mQHPI for each participant had been
      calculated by collecting the scores over the total number of surfaces examined.

      First visit after 14 days, from the baseline visit.

      Saliva collection and clinical periodontal parameters scoring (GI, BOP ,mQHP) will be
      performed again as described at baseline visit. The mouthwash bottles will be retrieved, and
      the remaining volume will be determining to further evaluate the compliance with mouth
      rinsing.

      (the total volume/bottle for two weeks will be 280 ml).

      For the purpose of self-assessment, a visual analog scale (VAS)- score based questionnaire
      was filled out by each participant at the end of the trial to evaluate the intervention. The
      questionnaire and method of data interpretation were adopted and modified from a previous
      study.
    

Intervention name(s): Perhyal rinse; Chlorhexidine mouthwash; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Filming mouthwash formulation, enriched with Hydrogen Peroxide and Hyaluronic Acid Subjects will then be given the test intervention, Perhyal rinse, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE). No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 14 days.; Subjects will then be given Chlorhexidine 0.12%mouthwash, as an active comparator, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE). No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 14 days.; Subjects will be given the nonactive control, distilled water, and will be asked to rinse with 10 ml of undiluted mouthwash for 60 s twice per day (30 min after tooth brushing) and will be instructed to refrain from eating and drinking for 30 min after rinsing. participants will be received a toothbrush with medium-hardness bristles and a toothpaste (COLGATE). No modifications to the participants' tooth brushing technique will be permitted. Next, the participants will be re-evaluated after 14 days.
Other intervention name(s): BMG0703; Chlorhexidine 0.12%; Placebo product
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gingivitis; Plaque; Hyaluronic acid; hydrogen peroxide