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

NCT04446533 | Unknown Phase 3

• 1 other identifier: Orto_BMG0703_PRD_June_2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Periodontitis; Bleeding Gum; Pocket, Periodontal

Keywords

Periodontitis; Bleeding Gum; Periodontal Pocket

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Change in Microbiological analysis

  0,3,7,30 days

Study Arms (3)

Hydrogen Peroxide and Hyaluronic acid (BMG0703)

EXPERIMENTAL

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

Chlorhexidine 0.2%

ACTIVE COMPARATOR

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%

Placebo product

PLACEBO COMPARATOR

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

Interventions

Hydrogen Peroxide and Hyaluronic acid filming formulation DRUG

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).

Also known as: BMG0703

Hydrogen Peroxide and Hyaluronic acid (BMG0703)

Chlorhexidine 0.2% DRUG

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).

Also known as: Chlorhexidine

Chlorhexidine 0.2%

Placebo DRUG

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).

Also known as: Placebo product

Placebo product

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of periodontitis with pockets between 3 and 7 mm
• Acceptance of informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead
• BMG Pharma: collaborator

Study Sites (1)

UOC Maxillofacial Surgery and Odontology, University of Milan

Milan, Lombardy, 20122, Italy

Location

Related Publications (5)

• Caton J, Greenstein G, Polson AM. Depth of periodontal probe penetration related to clinical and histologic signs of gingival inflammation. J Periodontol. 1981 Oct;52(10):626-9. doi: 10.1902/jop.1981.52.10.626.

  PMID: 6975365 BACKGROUND

• Fowler C, Garrett S, Crigger M, Egelberg J. Histologic probe position in treated and untreated human periodontal tissues. J Clin Periodontol. 1982 Sep;9(5):373-85. doi: 10.1111/j.1600-051x.1982.tb02048.x.

  PMID: 6754765 BACKGROUND

• Polson AM, Caton JG, Yeaple RN, Zander HA. Histological determination of probe tip penetration into gingival sulcus of humans using an electronic pressure-sensitive probe. J Clin Periodontol. 1980 Dec;7(6):479-88. doi: 10.1111/j.1600-051x.1980.tb02154.x.

  PMID: 6938528 BACKGROUND

• Keagle JG, Garnick JJ, Searle JR, King GE, Morse PK. Gingival resistance to probing forces. I. Determination of optimal probe diameter. J Periodontol. 1989 Apr;60(4):167-71. doi: 10.1902/jop.1989.60.4.167.

  PMID: 2724029 BACKGROUND

• Hull PS, Clerehugh V, Ghassemi-Aval A. An assessment of the validity of a constant force electronic probe in measuring probing depths. J Periodontol. 1995 Oct;66(10):848-51. doi: 10.1902/jop.1995.66.10.848.

  PMID: 8537866 BACKGROUND

MeSH Terms

Conditions

Periodontitis; Gingival Hemorrhage; Periodontal Pocket

Interventions

Hydrogen Peroxide; Chlorhexidine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Oral Hemorrhage; Gingival Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peroxides; Oxides; Anions; Ions; Electrolytes; Inorganic Chemicals; Reactive Oxygen Species; Free Radicals; Oxygen Compounds; Organic Chemicals; Biguanides; Guanidines; Amidines

Study Officials

• Giampietro Farronato, Professor

  University of Milan

  PRINCIPAL INVESTIGATOR

• Gianguido Cossellu, Fellow

  University of Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Occhipinti, Professor

CONTACT

+393339155689; Chiara.Occhipinti@unimi.it

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The products will be packaged in such a way that they are not recognizable either by the operator or 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 on the basis of 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. The data will be collected in pseudonymised form and inserted into a dedicated database in order to carry out the statistical analysis provided.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 25, 2020
• Study Start: June 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)