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

July 22, 2014 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
      • Mons, Belgium, 7000
        • Recruiting
        • Centre Hospitaliser Ambroise Paré
        • Contact:
      • Namur, Belgium, 5000
        • Recruiting
        • Clinique et Maternite Sainte Elisabeth
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: tooth extraction and insertion of PRF
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)

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

Other Names:
  • antibiotherapy before and after extraction
Procedure: atraumatic extraction
Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure
Other Names:
  • - atraumatic tooth extraction
  • - hermetic mucosal closure
Placebo Comparator: No PRF
Atraumatic extraction with antibiotic without PRF insertion
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

Other Names:
  • antibiotherapy before and after extraction
Procedure: atraumatic extraction
Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure
Other Names:
  • - atraumatic tooth extraction
  • - hermetic mucosal closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contribution of comorbidities factors in the appearance of osteonecrosis
Time Frame: 1 year

comorbidities:

  • diabetes,
  • immunosuppression (corticoids, chemotherapy, immunosuppressive treatment)
  • tobacco
1 year
Number of days in tooth-extraction healing in the two groups
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Study Chair: Hervé P Reychler, MD, DMD, Cliniques universitaires Saint-Luc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

July 15, 2014

First Submitted That Met QC Criteria

July 22, 2014

First Posted (Estimate)

July 23, 2014

Study Record Updates

Last Update Posted (Estimate)

July 23, 2014

Last Update Submitted That Met QC Criteria

July 22, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B403201318408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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