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
Sponsor study identifier
interventional
100
1 country
3
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
July 15, 2014
Actual (reported)July 23, 2014
Actual (reported)January 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Contribution of comorbidities factors in the appearance of osteonecrosis
1 year
Number of days in tooth-extraction healing in the two groups
2 months
Experimental: Atraumatic tooth extraction with antibiotics( amoxicillin clavulanate combination) .Insertion of PRF membrane in tooth-extraction site.
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
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Centre Hospitaliser Ambroise Paré
Mons, 7000, Belgium
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.
Hervé P Reychler, MD, DMD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
First Submitted
July 15, 2014
First Posted
July 23, 2014
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Estimated (date passed)Medical and Surgical Treatment of MRONJ (Medication-related Osteonecrosis of the Jaw Bones)
Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure
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Clinique et maternité Sainte Elisabeth
Namur, 5000, Belgium
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 23, 2014
Record last verified: 2014-07
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Source: ClinicalTrials.gov.
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