Status:
COMPLETED
Assessment of Platelet Rich Fibrin Efficiency on Healing Delay and on Jawbone Osteochemonecrosis Provoked by Bisphosphonates
Lead Sponsor:
Centre Hospitalier Régional Metz-Thionville
Conditions:
Jawbone Osteochemonecrosis Induced by Bisphosphonates
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The main objective of our study is to assess, after tooth extraction, the efficacity of PRF in the prevention of healing delay and of jawbone osteochemonecrosis induced by bisphosphonates
Detailed Description
Scientific Context Bisphosphonates (BP) work by slowing down bone remodelling. They are used in the management of different types of cancers and for the treatment of osteoporosis. Recent studies warne...
Eligibility Criteria
Inclusion
- Patient major(male or female)
- Documented indication at the initial visit at day 0 (JO) for a maximum extraction of 3 teeth.
- Treatment with nitrogenous or non-nitrogenous BP by intravenous injection or oral administration whichever the reason for this drug prescription:
- on going BP treatment
- patient having received a previous treatment with bisphosphonates (irrespective of the duration and withdrawal date of this treatment)
- Patient having received the specific information letter regarding the study and having signed the clarified consent form.
Exclusion
- Patient having a maxillary or mandibulary OCN at Day 0(JO)
- Positive HIV serology at Day 0(for patients belonging to the PRF group)
- Previous history of maxillo-cervico-facial radiotherapy
- Patients with estimated survival expectancy shorter than one year
- Lack of social security cover
- Inability of the patient to respect the study follow-up
- Patient having reached his/her majority and under tutelage,trusteeship or protection of the court
- Patient whose diagnosis could not be revealed to him/her (especially when the patient or their family expressed this wish).
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2017
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01526915
Start Date
September 1 2011
End Date
June 21 2017
Last Update
January 2 2020
Active Locations (5)
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1
Chu de Dijon
Dijon, France, 21033
2
Scm Bally Curien
Maxéville, France, 54320
3
Chr Metz Thionville
Metz, France, 57038
4
Chu de Nancy
Nancy, France, 54035