- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02382809
Efficacy of 0.2 % Digluconate Chlorhexidine Mouthwash for Preventing Alveolar Osteitis After Third Molar Extraction
March 8, 2016 updated by: Pierre Fabre Medicament
Efficacy of DC071 Mouthwash (0.2% Chlorhexidine Digluconate) in Peri-surgical Care for Preventing Alveolar Osteitis After Third Molar Extraction
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
414
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tallinn, Estonia
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Bordeaux, France
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Brest, France
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Dijon, France
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Lyon, France
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Metz, France
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Petit quevilly, France
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Pierre Benite, France
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Saint Maixent l'Ecole, France
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Strasbourg, France
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Toulouse, France
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Dauga Vpils, Latvia
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Liepaja, Latvia
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Riga, Latvia
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Valmiera, Latvia
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Kaunas, Lithuania
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Klaipeda, Lithuania
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Vilnius, Lithuania
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Mouthwash, twice daily
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Experimental: DC071 (0.2% chlorhexidine digluconate)
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Mouthwash, twice daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Occurrence of an alveolar osteitis
Time Frame: Within 7 days
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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.
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Within 7 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Françoise TONNER, Pierre Fabre Medicament
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
March 3, 2015
First Submitted That Met QC Criteria
March 6, 2015
First Posted (Estimate)
March 9, 2015
Study Record Updates
Last Update Posted (Estimate)
March 9, 2016
Last Update Submitted That Met QC Criteria
March 8, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DC0071 BB 4 05
- 2014-004682-24 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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