Clinical trial NCT02198001: Prospective Randomized Study: Assessment of PRF Efficacy in Prevention of Jaw Osteonecrosis After Tooth Extraction
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bisphosphonate-Associated Osteonecrosis of the Jaw
Keywords: Platelets
fibrin
growth factors
bisphosphonates
tooth extraction
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-07-23
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of jaw osteonecrosis after tooth extraction
timeFrame: 1year
Secondary outcomes:
Other outcomes:
measure: Contribution of comorbidities factors in the appearance of osteonecrosis
timeFrame: 1 year
measure: Number of days in tooth-extraction healing in the two groups
timeFrame: 2 months
Locations:
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint Luc
city: Mons
country: Belgium
facility: Centre Hospitaliser Ambroise Paré
city: Namur
country: Belgium
facility: Clinique et maternité Sainte Elisabeth
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Hervé P Reychler, MD, DMD
role: STUDY_CHAIR
References:
citation: Beth-Tasdogan NH, Mayer B, Hussein H, Zolk O, Peter JU. Interventions for managing medication-related osteonecrosis of the jaw. Cochrane Database Syst Rev. 2022 Jul 12;7(7):CD012432. doi: 10.1002/14651858.CD012432.pub3.