Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

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

Qualifiers

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

Treatments tested in this trial

  • Surgery with the use of L-PRF
  • Standard surgery

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators