About this trial
Medication-related osteonecrosis of the jaw (MRONJ) is a rare but serious side-effect of antiresorptive therapies used in the management of bone diseases, such as osteoporosis or bone metastases. A surgical management can lead to a resolution of the disease, but with perfectible results. For this purpose, the use of autologous platelet concentrates (APC) can be useful. With this study, researchers aim to demonstrate the efficacy of L-PRF (Leukocyte- and Platelet-Rich Fibrin) as an adjunct to the surgical treatment of MRONJ in terms of wound healing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
MRONJ requiring surgical treatment according to AAOMS criteria (stage 2 or 3; failure of first-line treatments; sequestration of a necrotic bone block), the resection of which needs general anesthesia;
Affiliates or beneficiaries of a social security scheme.
Having given free and informed written consent.
Disqualifiers
Presence of a maxillo-mandibular neoplastic lesion;
Presence of several MRONJ lesions;
History of cervico-facial radiotherapy;
Contraindication to general anesthesia;
Trial design
Parallel
Treatments tested in this trial
Surgery with the use of L-PRF
Procedure/SurgeryThe study protocol is the same as the standard surgery one but with additional use of L-PRF membranes
Standard surgery
Procedure/SurgeryThe standard surgical treatment, taking place in the operating room under general anesthesia
Treatment groups
Trial outcomes
Primary outcomes
Evaluation of the efficacy of the use of L-PRF during the surgical treatment of MRONJ, compared to surgical treatment alone, on complete mucosal healing.
Proportion of subjects presenting complete mucosal healing, i.e. a return to stage 0 or the "at risk" stage of the AAOMS classification.
Secondary outcomes
MRONJ stage - Month 1
Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).
MRONJ stage - Month 3
Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).
MRONJ stage - Month 6
Evaluation and comparison between the 2 groups of the evolution of the MRONJ stage - (improvement, stability, worsening).
the postoperative pain - Month 1
Pain will be subjectively evaluated by the patients using a Numerical Scale, according to a score from 0 (absence of pain) to 10 (maximum pain imaginable).
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: