Alveolar Osteitis Clinical Trial
Official title:
Efficacy of DC071 Mouthwash (0.2% Chlorhexidine Digluconate) in Peri-surgical Care for Preventing Alveolar Osteitis After Third Molar Extraction
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.
Status | Completed |
Enrollment | 414 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Pierre Fabre Medicament |
Estonia, France, Latvia, Lithuania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of an alveolar osteitis | The primary Outcome measure will be evaluated based on the absence/presence of an alveolar osteitis within 7 days after the extraction of the third molar. | Within 7 days | No |
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