Bisphosphonate-Associated Osteonecrosis of the Jaw Clinical Trial
Official title:
Prospective Randomized Clinical Study: Role of Platelet Rich Fibrin (PRF) in the Tooth Extraction Site in the Prevention of Jaw Osteonecrosis on Patients Under Bisphosphonates Therapy
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01325142 -
Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer
|
N/A | |
| Active, not recruiting |
NCT02932501 -
Medication-related Osteonecrosis of the Jaw (MRONJ) Registry
|