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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Bisphosphonate-Associated Osteonecrosis of the Jaw

Intervention / Treatment
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* Drug: tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine)
* Procedure: atraumatic extraction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients taking bisphosphonates whatever the indication, the type, the administration and the duration of treatment (we include patients taking or having taken bisphosphonates, even several years ago) And who need tooth extraction (not recoverable in conservative dentistry and symptomatic tooth: dental and periodontal infections, symptomatic traumatic tooth fracture). Exclusion Criteria: pregnant women younger than 50 years old jaw's radiotherapy history of jaw osteonecrosis jaw metastasis from an other cancer

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tooth extraction and insertion of PRF<br>Experimental: Atraumatic tooth extraction with antibiotics( amoxicillin clavulanate combination) .Insertion of PRF membrane in tooth-extraction site. | Drug: tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine)<br>* 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<br>* Other names: antibiotherapy before and after extraction;Procedure: atraumatic extraction<br>* Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure<br>* Other names: - hermetic mucosal closure;|
| Placebo Comparator: No PRF<br>Atraumatic extraction with antibiotic without PRF insertion | Drug: tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine)<br>* 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<br>* Other names: antibiotherapy before and after extraction;Procedure: atraumatic extraction<br>* Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure<br>* Other names: - hermetic mucosal closure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number 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 | 1year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelets, fibrin, growth factors, bisphosphonates, tooth extraction