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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Unknown

Conditions: Bisphosphonate-Associated Osteonecrosis of the Jaw

Treatments: Procedure: atraumatic extraction; Drug: tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine)

Study type: Interventional

Funder types: Other

Identifiers

NCT02198001

B403201318408

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

tooth extraction and insertion of PRF

Active Comparator group

Description:

Experimental: Atraumatic tooth extraction with antibiotics( amoxicillin clavulanate combination) .Insertion of PRF membrane in tooth-extraction site.

Treatment:

Drug: tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine)

Procedure: atraumatic extraction

No PRF

Placebo Comparator group

Description:

Atraumatic extraction with antibiotic without PRF insertion

Treatment:

Drug: tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine)

Procedure: atraumatic extraction