NCT02198001

Prospective Randomized Study: Assessment of PRF Efficacy in Prevention of Jaw Osteonecrosis After Tooth Extraction

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Bisphosphonate-Associated Osteonecrosis of the Jaw

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-01-01
• Completion: 2017-01-01
• First posted: 2014-07-23
• Last updated: 2014-07-23

Locations

3 sites across 1 country: Belgium