Efficacy of 0.2 % Digluconate Chlorhexidine Mouthwash for Preventing Alveolar Osteitis After Third Molar Extraction

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate the efficacy of 0.2 % digluconate chlorhexidine mouthwash in the prevention of alveolar osteitis following third molar extraction and to evaluate the safety and local tolerability.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Medicament
• Treatments: Chlorhexidine; Chlorhexidine gluconate

Criteria

Inclusion Criteria:

• Male or female over 18 years old

• Subject needing to undergo extraction of one impacted mandibular third molar

• For woman of childbearing potential and woman in post menopausal period under hormonal substitution treatment, she must accept to plan the extraction of the impacted mandibular third molar only during the last week of the menstrual cycle.

• Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation)

Exclusion Criteria:

• Existence or history of parotid gland disorders

• Acute or history of recent acute pericoronitis at any tooth

• Extraction of more than 1 third molar in the same surgical procedure

• Subject at high risk of bacterial endocarditis (prosthetic heart valve, history of bacterial endocarditis, congenital cyanogenic heart disease)

• Coagulation or haemostatic disorder or use of anticoagulants

• Hypersensitivity to chlorhexidine or any of the excipients;

• Hypersensitivity to any anesthetic agent;

• Hypersensitivity to corticosteroids, analgesics including opioid drugs used for post-surgery pain relief

• Intake of systemic vasodilator or vasoconstrictor

• Intake of systemic or local (in the mouth) antibiotics within 7 days before Day 1 and/or any pre- or post-operative antibiotic prophylaxis planned to be prescribed during the study;

• Use of any antiseptic mouthwash within 7 days before Day -1

• Regular heavy smokers (more than 20 cigarettes per day)

• Is pregnant or in post-partum period or a nursing mother