Assessment of Platelet Rich Fibrin Efficiency on Healing Delay and on Jawbone Osteochemonecrosis … (NCT01526915) | Clinical Trial Compass
CompletedNot Applicable
Assessment of Platelet Rich Fibrin Efficiency on Healing Delay and on Jawbone Osteochemonecrosis Provoked by Bisphosphonates
France52 participantsStarted 2011-09
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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).
What they're measuring
1
Delay in cicatrisation at week 8
Timeframe: 8 weeks
2
The appearance of osteochemonecrosis during the follow-up period