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.
Dental extractions are the main cause of jaw osteonecrosis in patients taking oral or iv bisphosphonates. This prospective randomized study will include a cohort of 100 patients treated with bisphosphonates (for benign or malignant conditions) and requiring dental extractions (non-retainable teeth for infectious, traumatic or parodontal reasons). 50 patients will benefit of PRF placement in the tooth extraction site (group 1) while 50 patients do not (group 2). The rest of the procedure will be the same in the 2 arms. In the literature, studies suggest a benefit from a long term antibiotherapy before and after tooth extraction. Extraction procedure should be the least traumatic as possible. The main objective of our study is to assess, after tooth extraction, the contribution of PRF in the prevention of jaw osteonecrosis induced by bisphosphonates. A follow-up period of one year after extraction is indicated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
100
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
Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure
Cliniques Universitaires Saint Luc
Brussels, Belgium
RECRUITINGCentre Hospitaliser Ambroise Paré
Mons, Belgium
RECRUITINGClinique et maternité Sainte Elisabeth
Namur, Belgium
RECRUITINGNumber of jaw osteonecrosis after tooth extraction
7 symptoms \> 6 weeks for the diagnosis of osteonecrosis: * bone exposure * bone spicule * mucosal inflammation * pain * paresthésias * suppuration * jaw fracture * number of jaw osteonecrosis after tooth extraction in the oral bisphosphonates group in comparison with the IV bisphosphonates group
Time frame: 1year
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