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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Current Primary Outcome: Number of jaw osteonecrosis after tooth extraction [ Time Frame: 1year ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Dates:
Date Received: July 15, 2014
Date Started: January 2014
Date Completion: January 2017
Last Updated: July 22, 2014
Last Verified: July 2014