Efficacy of Hyaluronic-acid and Hydrogen-Peroxide Mouthwash in Gingivitis Treatment

Study Overview
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Brief Summary
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A clinical study to evaluate the efficacy and safety of a mouthwash containing Hydrogen Peroxide, Sodium Hyaluronate and Glycine in the prevention and management of complications associated gingivitis by film forming action.

Detailed Description
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50 subjects will be enrolled, who show with gingivitis caused by accumulation of plaque and/or tartar selected consecutively. Subsequently, subjects will be equally divided and randomized into the test group or control group. During the three examinations, the subjects will undergo the collection of bleeding and plaque indices according to Silness J & Loe H 3,4. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered.

Official Title
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Efficacy of a Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid (BMG0703) in the Treatment of Inflammation and Bleeding Caused by Gingivitis, Compared to Placebo and 0.2% Chlorhexidine. A Randomised Controlled Clinical Trial.

Conditions
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Gingivitis, Bleeding Gum

Intervention / Treatment
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* Drug: Filming mouthwash formulation, enriched with Hydrogen Peroxide and Hyaluronic Acid
* Drug: Chlorhexidine mouthwash
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged between 12 and 50 years Presence of gingivitis caused by accumulation of plaque/tartar Acceptance of informed consent Exclusion Criteria: subjects suffering from HIV subjects suffering from hepatitis serious systemic diseases preventing the use of specific dental therapies acute and/or chronic infectious diseases inability to provide consent use of topical or systemic drugs inability to follow post-intervention hygiene instructions smokers

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 50 subjects affected with gingivitis, caused by accumulation of plaque and/or tartar, will be selected and enrolled in this study. Subsequently, subjects will be equally divided and randomly allocated to either the test group or the control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMG0703<br>Subjects will then be given the test product, BMG0703, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month. | Drug: Filming mouthwash formulation, enriched with Hydrogen Peroxide and Hyaluronic Acid<br>* Subjects will then be given the test product, BMG0703, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.<br>* Other names: BMG0703;|
| Active Comparator: Chlorhexidine 0.2%<br>Subjects will then be given a 0.2% Chlorhexidine product, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be reevaluated after 3 days and after one month. | Drug: Chlorhexidine mouthwash<br>* Subjects will then be given Chlorhexidine 0.2%mouthwash, as an active comparator, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.<br>* Other names: Chlorhexidine 0.2%;|
| Placebo Comparator: Placebo Product<br>Subjects will then be given a placebo product, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be reevaluated after 3 days and after one month. | Drug: Placebo<br>* Subjects will then be given a placebo product to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.<br>* Other names: Placebo product;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bleeding index | Subjects will undergo the measurement of bleeding index according to Silness J & Loe. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered. Data will be collected based on four possible clinical conditions: Code 0: absence of bleeding during probing depth measurement; Code 1: absence of bleeding during probing depth measurement, presence of redness and oedema; Code 2: presence of bleeding during probing depth measurement with redness and oedema; Code 3: spontaneous bleeding Higher score means worse outcome. | 0, 3, 30 days | 
| Change in Plaque index | Subjects will undergo the measurement of plaque index according to Silness J & Loe. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered. Data will be collected based on four possible clinical conditions: Code 0: absence of plaque; Code 1: presence of plaque not visible to the naked eye but evidenced by the periodontal probe passage; Code 2: presence of plaque at the level of the gingival margin; Code 3: abundant presence of plaque at the level of the gingival margin and/or the rest of the dental surface. The sum of the values of the four surfaces examined, divided by the very number of surfaces, will give the plaque and bleeding index value for each individual tooth. The sum of the indices of each examined tooth divided by the total number of teeth examined will indicate the overall plaque and bleeding index of the subject at that time. | 0, 3, 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingivitis, Bleeding, Plaque, Tartar