Efficacy of DC071 Mouthwash (0.2% Chlorhexidine Digluconate) in Peri-surgical Care for Preventing Alveolar Osteitis After Third Molar Extraction

Pierre Fabre Medicament0 sites414 target enrollmentMarch 2015

ConditionsAlveolar Osteitis

InterventionsPlacebo DC071

DrugsDC071 Placebo

Overview

Phase: Phase 4
Intervention: Placebo
Conditions: Alveolar Osteitis
Sponsor: Pierre Fabre Medicament
Enrollment: 414
Primary Endpoint: Occurrence of an alveolar osteitis
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

February 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pierre Fabre Medicament

Responsible Party

Sponsor

Eligibility 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;

Arms & Interventions

Placebo

Intervention: Placebo

DC071 (0.2% chlorhexidine digluconate)

Intervention: DC071

Outcomes

Primary Outcomes

Occurrence of an alveolar osteitis

Time Frame: Within 7 days

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.