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

Alveolar Osteitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382809
• Other study ID #: DC0071 BB 4 05
• Secondary ID: 2014-004682-24
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2015
• Last updated: March 8, 2016
• Start date: March 2015
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesEstonia: The State Agency of MedicineEstonia: Research Ethics CommitteeLatvia: State Agency of MedicinesLatvia: Institutional Review BoardLithuania: State Medicine Control Agency - Ministry of HealthLithuania: Bioethics CommitteeSpain: Spanish Agency of MedicinesSpain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alveolar Osteitis
• Dry Socket
• Osteitis

Intervention

Drug:
• DC071
Mouthwash, twice daily
• Placebo
Mouthwash, twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Countries where clinical trial is conducted

Estonia,  France,  Latvia,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of an alveolar osteitis	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.	Within 7 days	No