Efficacy of DC071 mouthwash (0,2 % chlorhexidine digluconate) in peri-surgical care for preventing alveolar osteitis after third molar extraction.

Phase 1

• Conditions: Prevention of alveolar osteitis after third molar extraction; MedDRA version: 18.0 Level: PT Classification code 10066995 Term: Alveolar osteitis System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2014-004682-24-FR
• Lead Sponsor: PIERRE FABRE MEDICAMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-19
• Study Completion: 2016-02-17
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 409

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 for woman in 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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 374
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the efficacy of chlorhexidine mouthwash in the prevention of alveolar osteitis following third molar extraction. ;Secondary Objective: To evaluate the safety and the local tolerability of DC071.;<br> Primary end point(s): Occurence of an alveolar osteitis (dry socket) within the 7 days after the extraction of the impacted mandibular third molar.<br> Alveolar osteitis will be recorded at Visit 4 (End-of-Study visit). <br> ;Timepoint(s) of evaluation of this end point: V4 (D8)