Effect of a Hydrogen-Peroxide and Hyaluronic-Acid Mouthwash (BMG0703) in the Treatment of Periodontitis

Study Overview
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Brief Summary
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Assessment of the efficacy of BMG0703 in the treatment of periodontitis and control of supragingival plaque, compared to Chlorhexidine and a placebo product

Detailed Description
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The enrolled subjects will be examined and treated by specialized medical personnel. Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home. Next, subjects will be divided into three groups: after the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with the test product, active comparator or placebo, with the aid of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes. One bottle of the product (test, comparative or placebo) will then be given to the patient who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week. The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth). Patients with allergic reactions or hypersensitivity due to the use of the products will be advised to discontinue the use of the products and seek medical advice.

Official Title
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Assessment of a Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid (BMG0703) in the Treatment of Periodontitis, Compared to Placebo and 0.2% Chlorhexidine. A Randomised Controlled Clinical Trial.

Conditions
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Periodontitis, Bleeding Gum, Pocket, Periodontal

Intervention / Treatment
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* Drug: Hydrogen Peroxide and Hyaluronic acid filming formulation
* Drug: Chlorhexidine 0.2%
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of periodontitis with pockets between 3 and 7 mm 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 pathologies 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: 18 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: Following a professional oral hygiene session, subjects will be divided into three groups: BMG0703, active comparator a nd placebo. First application of products will be applied clinically, and subsequently, one bottle of the product (test, comparative or placebo) will be given to the patient to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week. The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrogen Peroxide and Hyaluronic acid (BMG0703)<br>Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home. After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with BMG0703 by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes. One bottle of BMG0703 will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week. The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth). | Drug: Hydrogen Peroxide and Hyaluronic acid filming formulation<br>* Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home. After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with BMG0703 by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes. One bottle of BMG0703 will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week. The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).<br>* Other names: BMG0703;|
| Active Comparator: Chlorhexidine 0.2%<br>Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home. After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with Chlorhexidine 0.2% by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes. One bottle of Chlorhexidine 0.2% will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week. The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth). | Drug: Chlorhexidine 0.2%<br>* Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home. After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with Chlorhexidine 0.2% by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes. One bottle of Chlorhexidine 0.2% will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week. The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).<br>* Other names: Chlorhexidine;|
| Placebo Comparator: Placebo product<br>Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home. After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with a placebo product by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes. One bottle of the placebo product will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week. The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth). | Drug: Placebo<br>* Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home. After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with a placebo product by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes. One bottle of the placebo product will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week. The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth).<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, 7, 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. Higher score means worse outcome 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, 7, 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Microbiological analysis | The DNA-Sorb-B (Sacace) nucleic acid extraction kit will be used for the extraction and purification of bacterial DNA from clinical samples. Bacterial genome extraction is performed on 500 microlitres of oral sample fluid obtained from each patient. The molecular analysis, using Real Time PCR, involves the use of the KIT Periodontitis (PeriodontScreen Real-TM, Sacace), and in particular the following bacterial species will be researched: Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, Treponema denticola, Fusobacterium nucleatum, Prevotella intermedia, Tannerella forsythia, Porphyromonas endodontalis. Periodontopathogenic bacteria are divided into high (Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, Treponema denticle, Tannerella forsythia) and medium risk (Fusobacterium nucleatum, Prevotella Intermediate, Porphyromonas endodontalis). The results of the molecular analysis will be related to the clinical indices obtained from each patient. | 0,3,7,30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, Bleeding Gum, Periodontal Pocket