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

NCT02198001 | Unknown DMC

• 1 other identifier: B403201318408
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Bisphosphonate-Associated Osteonecrosis of the Jaw

Keywords

Platelets; fibrin; growth factors; bisphosphonates; tooth extraction

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (2)

• Contribution of comorbidities factors in the appearance of osteonecrosis

  1 year

• Number of days in tooth-extraction healing in the two groups

  2 months

Study Arms (2)

tooth extraction and insertion of PRF

ACTIVE COMPARATOR

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); Procedure: atraumatic extraction

No PRF

PLACEBO COMPARATOR

Atraumatic extraction with antibiotic without PRF insertion

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

Interventions

tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine) DRUG

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

Also known as: antibiotherapy before and after extraction

No PRF; tooth extraction and insertion of PRF

atraumatic extraction PROCEDURE

Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure

Also known as: - atraumatic tooth extraction, - hermetic mucosal closure

No PRF; tooth extraction and insertion of PRF

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• pregnant women
• younger than 50 years old
• jaw's radiotherapy
• history of jaw osteonecrosis
• jaw metastasis from an other cancer

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (3)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

RECRUITING

Centre Hospitaliser Ambroise Paré

Mons, 7000, Belgium

RECRUITING

Clinique et maternité Sainte Elisabeth

Namur, 5000, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 35866376 DERIVED

MeSH Terms

Conditions

Bisphosphonate-Associated Osteonecrosis of the Jaw

Interventions

Tooth Extraction; Anti-Bacterial Agents; Amoxicillin-Potassium Clavulanate Combination; Clindamycin

Condition Hierarchy (Ancestors)

Osteonecrosis; Bone Diseases; Musculoskeletal Diseases; Jaw Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates

Study Officials

• Hervé P Reychler, MD, DMD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  STUDY CHAIR

Central Study Contacts

Dorothée L Deneubourg, MD, DDS

CONTACT

003227645702; dorothee.deneubourg@uclouvain.be

Michèle Magremanne, MD, DDS

CONTACT

003227645711; michele.magremanne@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 23, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: July 23, 2014

Record last verified: 2014-07

Locations

BE (3)