Clinical trial NCT02382809: Efficacy of 0.2 % Digluconate Chlorhexidine Mouthwash for Preventing Alveolar Osteitis After Third Molar Extraction
Official title: Efficacy of DC071 Mouthwash (0.2% Chlorhexidine Digluconate) in Peri-surgical Care for Preventing Alveolar Osteitis After Third Molar Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alveolar Osteitis
Keywords: Alveolar osteitis
Third molar
Dry socket
Mouthwash
third molar extraction
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2015-03-09
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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;
* 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

Primary outcomes:
measure: Occurrence of an alveolar osteitis
timeFrame: Within 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tallinn
country: Estonia
city: Bordeaux
country: France
city: Brest
country: France
city: Dijon
country: France
city: Lyon
country: France
city: Metz
country: France
city: Petit quevilly
country: France
city: Pierre Benite
country: France
city: Saint Maixent l'Ecole
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Dauga Vpils
country: Latvia
city: Liepaja
country: Latvia
city: Riga
country: Latvia
city: Valmiera
country: Latvia
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Vilnius
country: Lithuania
Study officials:
affiliation: Pierre Fabre Medicament
name: Françoise TONNER
role: STUDY_DIRECTOR
References: