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

Bisphosphonate-Associated Osteonecrosis of the Jaw Clinical Trial

— PRF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02198001
• Other study ID #: B403201318408
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2014
• Last updated: July 22, 2014
• Start date: January 2014
• Est. completion date: January 2017

Study information

• Verified date: July 2014
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Dorothée L Deneubourg, MD, DDS
• Phone: 003227645702
• Email: dorothee.deneubourg[@]uclouvain.be
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bisphosphonate-Associated Osteonecrosis of the Jaw
• Osteonecrosis

Intervention

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

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint Luc	Bruxelles
Belgium	Centre Hospitaliser Ambroise Paré	Mons
Belgium	Clinique et maternité Sainte Elisabeth	Namur

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Contribution of comorbidities factors in the appearance of osteonecrosis	comorbidities: diabetes,; immunosuppression (corticoids, chemotherapy, immunosuppressive treatment); tobacco	1 year	No
Other	Number of days in tooth-extraction healing in the two groups		2 months	No
Primary	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	No