Non-Interventional Prospective Observational Study of Platelet Rich Fibrin as a Therapy Adjunctive in Patients with Medication-Related Osteonecrosis of the Jaw

Abstract

Background: Medication-related osteonecrosis (MRONJ) of the jaw is a severe and feared side effect of antiresorptive therapy in the oncological setting. With growing evidence that impaired angiogenesis may represent a key factor in pathogenesis, the aim of this study was to evaluate an autologous platelet concentrate as a possible additive in surgical therapy to optimize vascularization and, subsequently, resolution rates. Material and Methods: A non-interventional, prospective, multicenter study was conducted, and all patients with stage I-III MRONJ, undergoing antiresorptive therapy for an oncological indication, were included. The necrosis was treated surgically without (study arm A) or with (arm B) the addition of an autologous platelet concentrate (platelet-rich fibrin, PRF). Results: After 5, 14, and 42 days postoperative, wound healing (primary outcome: mucosal integrity) as well as downstaging, pain perception, and oral health-related quality of life (secondary outcome) were assessed via clinical evaluation. Among the 52 patients included, primarily with MRONJ stage I and II, the use of PRF as an additive in surgical therapy did not display a significant advantage for wound healing (p = 0.302), downstaging (p = 0.9), pain reduction (p = 0.169), or quality of life (p = 0.9). Summary: In conclusion, PRF as an adjunct did not significantly optimize wound healing. Further, no significant changes in terms of downstaging, pain sensation, and oral health-related quality of life were found.

Use of platelet concentrates in oral surgery of patients with osteonecrosis: a scoping review

“…One of these studies, a randomized clinical trial, reported that it was not possible to establish the advantage of using P-PRF despite observing a short-term improvement in quality of life and a reduction in postoperative pain and infections 21 . However, a prospective observational study did not show significant improvement in terms of downstaging, pain sensation, and quality of life-related to oral health 22 . In three studies, the P-PRF was evaluated and indicated as a step in the prevention of osteonecrosis of the jaws related to the use of antiresorptive and antiangiogenic drugs in patients requiring extractions 23 , 24 , 25 .…”

“…Eight studies used P-PRF as a platelet concentrate. Five studies evaluated the treatment for osteonecrosis of the mandible associated with bisphosphonates 18 , 19 , 20 , 21 , 22 , and two studies reported that it is not possible to prove the improvement in cases of osteonecrosis of the mandible with the use of this aggregating agent 21 , 22 . One of these studies, a randomized clinical trial, reported that it was not possible to establish the advantage of using P-PRF despite observing a short-term improvement in quality of life and a reduction in postoperative pain and infections 21 .…”

Evaluation of Various Therapeutic Approaches in Treating Medication-related Osteonecrosis of the Jaw: A Systematic Review

“…The use of Piezoelectric in surgery is considered a less aggressive option and has been cited as a good choice in MRONJ cases [60,71]. To enhance surgical outcomes, various adjuvant therapies have been proposed in the literature, including parathyroid hormone (PTH), laser therapy, hyperbaric oxygen therapy, ozone therapy, and platelet-rich plasma (L-PRP/PRGF/PRP) [47,49,51,52,63,29,75]. These adjuvant therapies have shown faster and more comfortable postoperative healing.…”

Reporting Criteria for Clinical Trials on Medication-Related Osteonecrosis of the Jaw (MRONJ): A Review and Recommendations

“…We also recommend establishing or using a scale or index to evaluate wound healing. In a very comprehensive approach, Blatt et al [ 89 ] combined eight items, each measured on a 5-point scale (with 0 indicating the lowest and 5 the highest value of the item): wound size, depth, necrotic tissue type, total amount of necrotic tissue, granulation tissue type, total amount of granulation tissue, edges, and peri-ulcer skin/mucosa viability. In addition, pain and oral health-related quality of life were assessed.…”