- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02198001
Prospective Randomized Study: Assessment of PRF Efficacy in Prevention of Jaw Osteonecrosis After Tooth Extraction (PRF)
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
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dorothée L Deneubourg, MD, DDS
- Phone Number: 003227645774 003227645702
- Email: dorothee.deneubourg@uclouvain.be
Study Contact Backup
- Name: Michele Magremanne, MD, DDS
- Phone Number: 003227645711
- Email: michele.magremanne@uclouvain.be
Study Locations
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Bruxelles, Belgium, 1200
- Recruiting
- Cliniques Universitaires Saint Luc
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Contact:
- Michele Magremanne, MD, DDS
- Phone Number: 003227645711
- Email: michele.magremanne@uclouvain.be
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Mons, Belgium, 7000
- Recruiting
- Centre Hospitaliser Ambroise Paré
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Contact:
- Catherine Vervaet, MD DDS
- Phone Number: 003265414190
- Email: catherine.vervaet@hap.be
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Namur, Belgium, 5000
- Recruiting
- Clinique et Maternité Sainte Elisabeth
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Contact:
- Patrice Lejuste, MD, DDS
- Phone Number: 003281720631
- Email: patrice.lejuste@cmsenamur.be
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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:
Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure
Other Names:
|
Placebo Comparator: No PRF
Atraumatic extraction with antibiotic without PRF insertion
|
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:
Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of jaw osteonecrosis after tooth extraction
Time Frame: 1year
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7 symptoms > 6 weeks for the diagnosis of osteonecrosis:
|
1year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contribution of comorbidities factors in the appearance of osteonecrosis
Time Frame: 1 year
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comorbidities:
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1 year
|
Number of days in tooth-extraction healing in the two groups
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
Investigators
- Study Chair: Hervé P Reychler, MD, DMD, Cliniques Universitaires Saint-Luc
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Musculoskeletal Diseases
- Stomatognathic Diseases
- Bone Diseases
- Jaw Diseases
- Osteonecrosis
- Bisphosphonate-Associated Osteonecrosis of the Jaw
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- beta-Lactamase Inhibitors
- Anti-Bacterial Agents
- Amoxicillin
- Clavulanic Acid
- Clavulanic Acids
- Amoxicillin-Potassium Clavulanate Combination
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.
Clinical Trials on Bisphosphonate-Associated Osteonecrosis of the Jaw
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Fundació d'investigació Sanitària de les Illes...RecruitingOsteonecrosis of the Jaw, Bisphosphonate Induced | Osteonecrosis of the Jaw, Bisphosphonate RelatedSpain
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Micromedic Technologies LtdUnknownBisphosphonate-related Osteonecrosis of the JawIsrael
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Centre Hospitalier Universitaire de NīmesCompletedChildren | Adverse Events | Bone Fragile | Bisphosphonate-Associated OsteonecrosisFrance
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AO Clinical Investigation and Publishing DocumentationAOCMFActive, not recruitingBisphosphonate-Associated Osteonecrosis of the Jaw | Medication-related Osteonecrosis of the JawGermany, Qatar, Switzerland, Finland, United States, Slovenia, Spain, Netherlands, Romania, Korea, Republic of
-
University of PennsylvaniaCompletedHealthy Volunteers | Atypical Femur Fracture | Osteoporosis, With or Without Treatment | Bisphosphonate Treatment | Bisphosphonate Related Osteonecrosis of the Jaws (BRONJ)United States
-
University of BolognaCompletedEndodontically Treated Teeth | Root Canal Infection | Periapical Abscess | Bisphosphonate-Associated Osteonecrosis
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University of ArkansasCompletedOsteoradionecrosis of the Jaw | Bisphosphonate-associated ONJ | Osteomyelitis of the Jaw | Osteolytic Lesions of the JawUnited States
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University of MichiganM.D. Anderson Cancer Center; Memorial Sloan Kettering Cancer Center; National... and other collaboratorsCompletedBone Diseases | Osteonecrosis | Metastases | Bisphosphonate-Associated Osteonecrosis of the JawUnited States
Clinical Trials on tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine)
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University of IowaOsteogenics BiomedicalCompletedAtrophy of Edentulous Alveolar RidgeUnited States
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The European Research Group on Periodontology (ERGOPerio)The University of Hong KongCompletedTooth Extraction Status Nos
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Universidad Complutense de MadridActive, not recruitingDental Implants | Alveolar Ridge PreservationSpain
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Cairo UniversityRecruitingBone Resorption | Socket Preservation | Alveolar Bone ResorptionEgypt
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Boston Children's HospitalWithdrawnFocal Infection, Dental
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Wake Forest University Health SciencesNational Institute of Dental and Craniofacial Research (NIDCR)CompletedBacteremiaUnited States
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Nantes University HospitalUnknown
-
Franciscus GasthuisErasmus Medical CenterCompletedNeonatal Infection | Neonatal SEPSISNetherlands
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Hospital de GranollersCompleted
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Prince Sattam Bin Abdulaziz UniversityActive, not recruitingBone Augmentation | Tooth Extraction Status NosSaudi Arabia