Bisphosphonate-Associated Osteonecrosis of the Jaw
Conditions
Keywords
Platelets, fibrin, growth factors, bisphosphonates, tooth extraction
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.
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.
Interventions
DRUGtooth 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
PROCEDUREatraumatic extraction
Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of jaw osteonecrosis after tooth extraction | 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
| Measure | Time frame | Description |
|---|---|---|
| Contribution of comorbidities factors in the appearance of osteonecrosis | 1 year | comorbidities: * diabetes, * immunosuppression (corticoids, chemotherapy, immunosuppressive treatment) * tobacco |
| Number of days in tooth-extraction healing in the two groups | 2 months | — |
Countries
Belgium
Contacts
Primary ContactDorothée L Deneubourg, MD, DDS
Backup ContactMichèle Magremanne, MD, DDS
Outcome results
None listed