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

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ClinicalTrials.gov Identifier: NCT02198001
Recruitment Status : Unknown
Verified July 2014 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
First Posted : July 23, 2014
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.


Condition or disease Intervention/treatment Phase
Bisphosphonate-Associated Osteonecrosis of the Jaw Drug: tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine) Procedure: atraumatic extraction Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : January 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis
Drug Information available for: Amoxicillin

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 Name: 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 Name: 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




Primary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Contribution of comorbidities factors in the appearance of osteonecrosis [ Time Frame: 1 year ]

    comorbidities:

    • diabetes,
    • immunosuppression (corticoids, chemotherapy, immunosuppressive treatment)
    • tobacco

  2. Number of days in tooth-extraction healing in the two groups [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198001


Contacts
Contact: Dorothée L Deneubourg, MD, DDS 003227645702 ext 003227645774 dorothee.deneubourg@uclouvain.be
Contact: Michèle Magremanne, MD, DDS 003227645711 michele.magremanne@uclouvain.be

Locations
Belgium
Cliniques Universitaires Saint Luc Recruiting
Bruxelles, Belgium, 1200
Contact: Michele Magremanne, MD, DDS    003227645711    michele.magremanne@uclouvain.be   
Centre Hospitaliser Ambroise Paré Recruiting
Mons, Belgium, 7000
Contact: Catherine Vervaet, MD DDS    003265414190    catherine.vervaet@hap.be   
Clinique et maternité Sainte Elisabeth Recruiting
Namur, Belgium, 5000
Contact: Patrice Lejuste, MD, DDS    003281720631    patrice.lejuste@cmsenamur.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Study Chair: Hervé P Reychler, MD, DMD Cliniques universitaires Saint-Luc

Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02198001     History of Changes
Other Study ID Numbers: B403201318408
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: July 2014

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Platelets
fibrin
growth factors
bisphosphonates
tooth extraction

Additional relevant MeSH terms:
Osteonecrosis
Bisphosphonate-Associated Osteonecrosis of the Jaw
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Jaw Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Antibiotics, Antitubercular
Diphosphonates
Anti-Infective Agents
Antitubercular Agents
Bone Density Conservation Agents
Physiological Effects of Drugs
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors