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

NCT07464678 | Completed

• 1 other identifier: 2021_808
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Medication Related Osteonecrosis of the Jaw

Keywords

PRF; MRONJ; osteonecrosis of the jaw; Platelet Rich Fibrin; Medication Related Osteonecrosis of the Jaw

Outcome Measures

Primary Outcomes (3)

• Clinical Healing of the Surgical Site in Medication-Related Osteonecrosis of the Jaw (MRONJ)

  Clinical healing of the surgical site assessed during standardized intraoral examination and categorized into three predefined groups: * Complete healing - full mucosal coverage without exposed necrotic bone; * Partial wound dehiscence \<50% of the surgical incision; * Partial wound dehiscence ≥50% of the surgical incision. Assessment performed by trained surgeons.

  14 days post-surgery

• Clinical Healing of the Surgical Site in Medication-Related Osteonecrosis of the Jaw (MRONJ)

  Clinical healing of the surgical site assessed during standardized intraoral examination and categorized into three predefined groups: * Complete healing - full mucosal coverage without exposed necrotic bone; * Partial wound dehiscence \<50% of the surgical incision; * Partial wound dehiscence ≥50% of the surgical incision. Assessment performed by trained surgeons.

  6 weeks post-surgery

• Clinical Healing of the Surgical Site in Medication-Related Osteonecrosis of the Jaw (MRONJ)

  Clinical healing of the surgical site assessed during standardized intraoral examination and categorized into three predefined groups: * Complete healing - full mucosal coverage without exposed necrotic bone; * Partial wound dehiscence \<50% of the surgical incision; * Partial wound dehiscence ≥50% of the surgical incision. Assessment performed by trained surgeons.

  6 months post-surgery

Secondary Outcomes (6)

• Health-related quality of life assessed using the EQ-5D Visual Analog Scale (EQ-VAS)

  Baseline (pre-surgery), 6 weeks post-surgery, 6 months post-surgery

• Preoperative serum C-reactive protein (CRP) concentration

  Baseline (preoperative) only

• Preoperative serum total protein concentration

  Baseline (preoperative)

• Preoperative weight [kg]

  Baseline (preoperative)

• Preoperative white blood cell (WBC) count

  Baseline (preoperative)

Study Arms (2)

Surgical Treatment With Platelet-Rich Fibrin (PRF)

EXPERIMENTAL

Patients undergoing surgical treatment for osteonecrosis of the jaw with adjunctive application of platelet-rich fibrin (PRF).

Procedure: Surgical Application of Platelet-Rich Fibrin (PRF)

Standard Surgical Treatment

NO INTERVENTION

Participants undergoing standard surgical treatment for osteonecrosis of the jaw without adjunctive platelet-rich fibrin (PRF) application.

Interventions

Surgical Application of Platelet-Rich Fibrin (PRF) PROCEDURE

Application of platelet-rich fibrin (PRF) to the surgical site during procedure in patients with medication-related osteonecrosis of the jaw (MRONJ).

Surgical Treatment With Platelet-Rich Fibrin (PRF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with medication-related osteonecrosis of the jaw (MRONJ) according to the criteria established by the American Association of Oral and Maxillofacial Surgeons (AAOMS).
• patients aged ≥18 years

You may not qualify if:

• Presence of metastases to the bones of the head and neck.
• History of hematologic disorders, including leukemia or thalassemia.
• Any condition or comorbidity that, in the investigator's judgment, would interfere with the patient's ability to safely participate in the study or comply with the protocol.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Wielkopolska, 60-355 Poznań, Poland

Location

Study Officials

• Aleksy Nowak

  Poznan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the surgical nature of the intervention, blinding of participants and treating surgeons was not feasible. The study was therefore conducted without masking. Randomization was used solely for allocation of participants to either the intervention group or the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomized after enrollment using a sealed envelope method. Prior to the initiation of patient recruitment, 50 sequentially numbered, opaque envelopes were prepared by an independent individual not involved in patient recruitment, treatment, or outcome assessment. Each envelope contained a card indicating either "PRF" or "Control." After eligibility confirmation and inclusion in the study, each participant was assigned to the next envelope in sequence, which was then opened to determine group allocation. This procedure ensured allocation concealment and minimized the risk of selection bias.

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: March 11, 2026
• Study Start: March 15, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 11, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)