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

Phase 4

Completed

• Conditions: Alveolar Osteitis
• Interventions: Drug: Placebo; Drug: DC071

• Registration Number: NCT02382809
• Lead Sponsor: Pierre Fabre Medicament

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-06
• Study First Posted: 2015-03-09
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-08
• Last Update Posted: 2016-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 414

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
DC071 (0.2% chlorhexidine digluconate)	DC071	-

Primary Outcome Measures

Name	Time	Method
Occurrence of an alveolar osteitis	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.