Evaluation of Hydrogen Peroxide and Hyaluronic Acid (BMG0703) in the Healing of Post-extraction Sites

PHASE3UnknownINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

June 30, 2020

Primary Completion Date

July 31, 2020

Study Completion Date

July 31, 2020

Conditions
Impacted Third Molar ToothHealing Surgical Wounds
Interventions
DRUG

Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid

"The enrolled subjects will be examined and treated by specialized medical personnel.~The extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.~From a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.~The treatment to be evaluated involves mouth rinsing with 10 ml of BMG0703 three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).~Patients with allergic reactions or hypersensitivity to the product will be advised to discontinue its use, and seek medical advice."

DRUG

Chlorhexidine mouthwash

"The enrolled subjects will be examined and treated by specialized medical personnel.~The extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.~From a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.~Subjects in this group are to use Chlorhexidine 0.2% mouthwash as an active comparator; 10 ml three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).~Patients with allergic reactions or hypersensitivity to Chlorhexidine will be advised to discontinue its use, and seek medical advice."

OTHER

Placebo product

"The enrolled subjects will be examined and treated by specialized medical personnel.~The extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.~From a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.~Subjects in this group are to use a placebo product, and will be instructed to use 10 ml for mouth rinsing three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).~Patients with allergic reactions or hypersensitivity to the product will be advised to discontinue its use, and seek medical advice."

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

NCT04438434 - Evaluation of Hydrogen Peroxide and Hyaluronic Acid (BMG0703) in the Healing of Post-extraction Sites | Biotech Hunter | Biotech Hunter