Prospective Randomized Study: Assessment of PRF Efficacy in Prevention of Jaw Osteonecrosis After Tooth Extraction
NCT ID: NCT02198001
Last Updated: 2014-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2014-01-31
2017-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Leukocyte- and Platelet Rich Fibrin (L-PRF) Application in Impacted Mandibular Third Molar Removal Surgery
NCT03357484
The Use of Platelet-rich-fibrin in Lower Third Molar Surgery.
NCT06165692
The Use of Injectable-Platelet Rich Fibrin (i-PRF) in the Lower Third Molar Extraction
NCT06073535
Effect of Autologous Platelet Rich Fibrin on Post-Operative Complications and Healing Following the Extraction
NCT06609967
The Effect of Platelet-rich Fibrin on Clinical and Patient-centered Outcomes of Third Molar Extractions
NCT05089812
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
tooth extraction and insertion of PRF
Experimental: Atraumatic tooth extraction with antibiotics( amoxicillin clavulanate combination) .Insertion of PRF membrane in tooth-extraction site.
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
atraumatic extraction
Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure
No PRF
Atraumatic extraction with antibiotic without PRF insertion
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
atraumatic extraction
Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
atraumatic extraction
Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* And who need tooth extraction (not recoverable in conservative dentistry and symptomatic tooth: dental and periodontal infections, symptomatic traumatic tooth fracture).
Exclusion Criteria
* younger than 50 years old
* jaw's radiotherapy
* history of jaw osteonecrosis
* jaw metastasis from an other cancer
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hervé P Reychler, MD, DMD
Role: STUDY_CHAIR
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cliniques Universitaires Saint Luc
Brussels, , Belgium
Centre Hospitaliser Ambroise Paré
Mons, , Belgium
Clinique et maternité Sainte Elisabeth
Namur, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B403201318408
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.