NCT07464678

Use of Platelet-Rich Fibrin (PRF) in the Management of Medication-Related Osteonecrosis of the Jaw (MRONJ)

Effectiveness of Platelet-Rich Fibrin in the Surgical Management of Medication-Related Osteonecrosis of the Jaw: A Randomized Prospective Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Poznan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Medication-Related Osteonecrosis of the Jaw (MRONJ) is a severe and increasingly prevalent clinical condition, defined as the presence of exposed mandibular or maxillary bone in the oral cavity persisting for at least eight weeks. The rising incidence of osteonecrosis of the jaw is closely associated with the widespread use of antiresorptive agents, such as bisphosphonates and denosumab, particularly in patients treated for malignant diseases and metabolic bone disorders. The condition is frequently accompanied by pain, inflammation, infection, and functional impairment, all of which significantly reduce patients' quality of life. Despite advances in medical management, conservative treatment strategies have demonstrated limited effectiveness, especially in advanced stages of the disease. Surgical intervention, including resection of necrotic bone or segmental bone resection with removal of necrotic tissue, has been shown to provide more favorable outcomes. However, surgical treatment remains associated with a considerable risk of postoperative complications, delayed or impaired wound healing, and recurrence of symptoms. One promising adjunctive approach is the use of platelet-rich fibrin (PRF), an autologous biomaterial with documented regenerative and anti-inflammatory properties. PRF has been used in oral and maxillofacial surgery for over a decade and may enhance both soft tissue and bone healing. The application of PRF to fill the post-resection defect and, when necessary, to cover the surgical site in cases of insufficient mucosal tissue has shown encouraging results. Evidence from individual case reports, animal studies, and preliminary clinical trials suggests that PRF may improve wound healing, reduce postoperative complications, and decrease the risk of disease recurrence. The aim of the present study is to evaluate the effectiveness of PRF as an adjunctive treatment in the surgical management of osteonecrosis of the jaw. Patients will be assessed at predefined follow-up intervals of 14 days, 6 weeks, and 6 months postoperatively. Study participants will be allocated to a control group receiving standard surgical treatment and a study group undergoing surgical treatment supplemented with PRF application. Comparative analysis between the groups will be performed to assess treatment outcomes.

Detailed description

Qualification for surgical treatment was based on the decision of a qualified specialist in maxillofacial surgery. During the procedure, a mucoperiosteal flap was elevated to expose the necrotic lesion. Any fistulas present were excised. Necrotic sequestra or necrotically altered bone were removed, and the extent of bone resection was determined based on the presence of bleeding from viable bone. Patients in the study group were operated on according to a protocol in which a PRF clot was applied to the surgical site following removal of the necrotic tissue. Platelet-Rich Fibrin (PRF) was prepared according to the Choukroun A-PRF+ protocol. A total of 40 mL of autologous venous blood was collected into four 10 mL glass tubes without additives and immediately centrifuged at 1300 rpm for 14 minutes using a PRF Duo Quattro centrifuge (Process for PRF, Nice, France). The surgical wound was closed with sutures, avoiding excessive tissue tension. All patients received antibiotic prophylaxis consisting of amoxicillin with clavulanic acid (875 mg + 125 mg, twice daily) or clindamycin (600 mg, three times daily) in cases of penicillin allergy, administered 12 hours prior to surgery. Antibiotic therapy was continued for 14 days postoperatively. When microbiological swab results and an antibiogram were available, antibiotic therapy was modified accordingly. Postoperatively, patients were instructed on proper oral hygiene and were prescribed a 0.2% chlorhexidine mouth rinse. All procedures were performed in a standardized manner by surgical teams consisting of a specialist and a resident or two specialists in order to ensure comparability of results. No patient in the study group reported serious adverse events related to the PRF harvesting procedure. In the postoperative period, patients occasionally reported bruising at the venipuncture site, mild swelling, or minimal pain. Follow-up was conducted in the outpatient clinic according to a predefined standardized protocol, including visits at 14 days, 6 weeks, and 6 months after surgery. During each visit, clinical and radiological parameters were assessed, including soft tissue healing, presence or absence of bone exposure, pain complaints, AAOMS (American Association of Oral and Maxillofacial Surgeons) stage, quality of life, presence of exudate, and radiological findings. Assessments were performed by different members of the clinical team in order to limit subjective bias and increase the reliability of the obtained results.

Conditions

• Medication Related Osteonecrosis of the Jaw

Interventions

Type	Name	Description
PROCEDURE	Surgical Application of Platelet-Rich Fibrin (PRF)	Application of platelet-rich fibrin (PRF) to the surgical site during procedure in patients with medication-related osteonecrosis of the jaw (MRONJ).

Timeline

• Start date: 2022-03-15
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

1 site across 1 country: Poland