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

Pierre Fabre

Status and phase

Completed

Phase 4

Conditions

Alveolar Osteitis

Treatments

Drug: Placebo

Drug: DC071

Study type

Interventional

Funder types

Industry

Identifiers

NCT02382809

2014-004682-24 (EudraCT Number)

DC0071 BB 4 05

Details and patient eligibility

About

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.

Enrollment

414 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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