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

PHASE3UnknownINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

June 30, 2020

Primary Completion Date

July 31, 2020

Study Completion Date

July 31, 2020

Conditions
PeriodontitisBleeding GumPocket, Periodontal
Interventions
DRUG

Hydrogen Peroxide and Hyaluronic acid filming formulation

"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

Chlorhexidine 0.2%

"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

Placebo

"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)."

Trial Locations (1)

20122

UOC Maxillofacial Surgery and Odontology, University of Milan, Milan

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

BMG Pharma

INDUSTRY

lead

University of Milan

OTHER

NCT04446533 - Effect of a Hydrogen-Peroxide and Hyaluronic-Acid Mouthwash (BMG0703) in the Treatment of Periodontitis | Biotech Hunter | Biotech Hunter