Prospective Randomized Study: Assessment of PRF Efficacy in Prevention of Jaw Osteonecrosis After Tooth Extraction
NCT02198001 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2014-07-23
Summary
This prospective study will include patients taking or having taken bisphosphonates and needing dental extractions.
The aim of this study is to validate the contribution of PRF (Platelet Rich Fibrin) in tooth extraction sites.
In the test group (PRF) and in the control group (no PRF), we use the same atraumatic extraction protocol associated with the same antibiotic procedure.
Conditions
- Bisphosphonate-Associated Osteonecrosis of the Jaw
Interventions
- DRUG
-
tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine)
BPs per os\< 3ans: amoxicillin- clavulanate J-1 à J+10 BPs IV ou per os\> 3ans ou per os + comordibities (diabetes, immunosuppression, tobacco): amoxicillin- clavulanate J-3 à J+10 In case of allergy: BPs per os: clindamycine J-1 à J+10 BPs IV ou per os\> 3ans ou per os + comordibities (diabetes, immunosuppression, tobacco): clindamycine J-3 à J+10
- PROCEDURE
-
atraumatic extraction
Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure
Sponsors & Collaborators
-
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
lead OTHER
Principal Investigators
-
Hervé P Reychler, MD, DMD · Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2016-01-31
- Completion
- 2017-01-31
Countries
- Belgium
Study Locations
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