Efficacy of 0.2 % Digluconate Chlorhexidine Mouthwash for Preventing Alveolar Osteitis After Third Molar Extraction
NCT ID: NCT02382809
Last Updated: 2016-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
414 participants
INTERVENTIONAL
2015-03-31
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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DC071 (0.2% chlorhexidine digluconate)
DC071
Mouthwash, twice daily
Placebo
Placebo
Mouthwash, twice daily
Interventions
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DC071
Mouthwash, twice daily
Placebo
Mouthwash, twice daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Principal Investigators
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Françoise TONNER
Role: STUDY_DIRECTOR
Pierre Fabre Medicament
Locations
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Tallinn, , Estonia
Bordeaux, , France
Brest, , France
Dijon, , France
Le Petit-Quevilly, , France
Lyon, , France
Metz, , France
Pierre-Bénite, , France
Saint-Maixent-l'École, , France
Strasbourg, , France
Toulouse, , France
Daugavpils, , Latvia
Liepāja, , Latvia
Riga, , Latvia
Valmiera, , Latvia
Kaunas, , Lithuania
Klaipėda, , Lithuania
Vilnius, , Lithuania
Countries
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Other Identifiers
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2014-004682-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DC0071 BB 4 05
Identifier Type: -
Identifier Source: org_study_id
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