Surgery with leukocyte and platelet-rich fibrin (L-PRF) vs. surgery alone for medication-related osteonecrosis of the jaw: A randomized controlled trial.

Abstract

Background: Multiple studies have reported high resolution rates of medication-related osteonecrosis of the jaw (MRONJ) with surgical treatment combined with platelet concentrates. However, no randomized controlled trials have been published to date comparing surgery combined with L-PRF to surgery alone.

Material and methods: We conducted a multicenter, open-label, parallel-group, randomized controlled trial to assess the effect of leukocyte- and platelet-rich fibrin (L-PRF) as an adjunct to surgery for the treatment MRONJ. Patients were randomly assigned to either surgery combined with L-PRF or surgery alone. The primary outcome was the proportion of patients achieving complete resolution of MRONJ lesions six months postoperatively. Complete resolution rates were compared using the chi-square (X²) test, and relative risk (RR) with 95% confidence intervals (CI) was calculated. Secondarily, we evaluated baseline quality of life using the EQ-5D-3L questionnaire and assessed the impact of L-PRF on quality-of-life measures.

Results: A total of 41 participants were included in the study. Nineteen participants underwent surgery with L-PRF, while 22 underwent surgery alone. At the six-month follow-up, complete resolution was observed in 92% (11/12) of patients in the experimental group and 83% (15/18) in the control group (RR 1.1, 95% CI 0.84-1.43, p=0.51). The most affected domains in the baseline quality-of-life assessment were anxiety/depression and pain/discomfort. No statistically significant differences were observed between groups in any quality-of-life domain at six months.

Conclusions: Our findings suggest that the use of L-PRF as an adjunct to surgery does not provide a significant clinical benefit compared to surgery alone. Key words:Platelet-rich fibrin, quality of life, osteonecrosis, randomized controlled trial.