Use of Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw: a Randomized Controlled Trial (PeRFOrMand)

NCT06419010 NA NOT_YET_RECRUITING

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.

Details

Lead sponsor	University Hospital, Toulouse
Phase	NA
Status	NOT_YET_RECRUITING
Enrolment	150
Start date	2024-05
Completion	2027-05

Conditions

• Osteonecrosis of the Jaw

Interventions

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

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. — 6 months postoperatively
  Proportion of subjects presenting complete mucosal healing, i.e. a return to stage 0 or the "at risk" stage of the AAOMS classification.

Countries

France