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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| No PRF | Placebo Comparator | Atraumatic extraction with antibiotic without PRF insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine) | Drug | BPs per os< 3ans: amoxicillin- clavulanate J-1 Ã J+10 BPs IV ou per os> 3ans ou per os + comordibities (diabetes, immunosuppression, tobacco): amoxicillin- clavulanate J-3 Ã J+10 In case of allergy: BPs per os: clindamycine J-1 Ã J+10 BPs IV ou per os> 3ans ou per os + comordibities (diabetes, immunosuppression, tobacco): clindamycine J-3 Ã J+10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of jaw osteonecrosis after tooth extraction | 7 symptoms > 6 weeks for the diagnosis of osteonecrosis:
| 1year |
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| Measure | Description | Time Frame |
|---|---|---|
| Contribution of comorbidities factors in the appearance of osteonecrosis | comorbidities:
| 1 year |
| Number of days in tooth-extraction healing in the two groups |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dorothée L Deneubourg, MD, DDS | Contact | 003227645702 | 003227645774 | dorothee.deneubourg@uclouvain.be |
| Michèle Magremanne, MD, DDS | Contact | 003227645711 | michele.magremanne@uclouvain.be |
| Name | Affiliation | Role |
|---|---|---|
| Hervé P Reychler, MD, DMD | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires Saint Luc | Recruiting | Brussels | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35866376 | Derived | 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. |
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|
|
| atraumatic extraction | Procedure | Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure |
|
|
| 2 months |
| Centre Hospitaliser Ambroise Paré | Recruiting | Mons | 7000 | Belgium |
|
| Clinique et maternité Sainte Elisabeth | Recruiting | Namur | 5000 | Belgium |
|
| ID | Term |
|---|---|
| D059266 | Bisphosphonate-Associated Osteonecrosis of the Jaw |
| ID | Term |
|---|---|
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014081 | Tooth Extraction |
| D000900 | Anti-Bacterial Agents |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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