L-PRF in Prevention of ORN and MRONJ Following Tooth Extractions;v3.0

May 6, 2026 updated by: Swansea Bay University Health Board

Role of Platelet-Rich Fibrin in the Prevention of Osteoradionecrosis and Medication-related Osteonecrosis of the Jaw Following Tooth Extractions: A Prospective, Triple-Blind, Randomised Feasibility Trial

Osteoradionecrosis (ORN) and medication-related osteonecrosis of the jaw (MRONJ) are debilitating complications following dental extractions in patients who have received head and neck radiotherapy or antiresorptive therapy. These conditions are associated with significant morbidity, including persistent pain, poor oral function, and reduced quality of life.

While preventive strategies remain limited, platelet-rich fibrin (L-PRF), an autologous fibrin matrix enriched with growth factors, has shown potential in promoting wound healing and modulating inflammation. This prospective, triple-blind, randomised pilot trial aims to evaluate the effectiveness of L-PRF in enhancing socket healing and reducing the incidence of ORN and MRONJ. Forty patients (20 post-radiotherapy, 20 on antiresorptive agents) undergoing non-surgical dental extractions will be randomised to receive either L-PRF or standard care. The primary outcome is mucosal healing at Day 10 post-extraction, assessed using the Landry wound healing index. Secondary outcomes include the incidence of ORN or MRONJ at extraction sites assessed at 9, 17, 25, and 52 weeks. This study aims to provide early evidence on the clinical utility of L-PRF in preventing osteonecrosis in high-risk patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Osteoradionecrosis (ORN) is a condition in which necrosis of the jawbone occurs in patients who have previously undergone radiotherapy for head and neck cancer. Medication-Related Osteonecrosis of the Jaw (MRONJ) occurs in patients receiving, or who have received, antiresorptive therapies such as bisphosphonates or denosumab. Both conditions share underlying mechanisms including impaired bone healing, chronic inflammation, and disrupted angiogenesis . Patients in either group face an increased risk of poor healing following tooth extraction, which can result in persistent pain, infection, and progressive jawbone necrosis. These complications profoundly impair patients' abilities to eat and speak, significantly reducing their quality of life.

ORN and MRONJ are extremely difficult to predict, prevent, and manage. Treatment typically requires removal of necrosed bone followed by complex reconstructive procedures that consume significant hospital resources, including materials, staff time, and prolonged hospital stays. Despite these interventions, patients often experience substantial reductions in quality of life. The economic burden on the NHS and responsible trusts is considerable, underscoring the urgent need for improved preventive approaches.

Leukocyte- and platelet- rich fibrin (L-PRF), an autologous leukocyte and platelet concentrate, has demonstrated promising results in promoting soft tissue and bone healing, owing to its angiogenic, anti-inflammatory, and regenerative properties . Its use in dental extractions could mitigate the risk of developing ORN or MRONJ in high-risk populations.

L-PRF is a second-generation platelet concentrate that releases growth factors such as PDGF, TGF-β, and VEGF over an extended period. In vitro studies show that its three-dimensional fibrin matrix continuously releases these factors and cytokines for up to 21 days, which helps regulate inflammation and promote angiogenesis, supporting tissue healing.

L-PRF, a second-generation platelet concentrate, has gained popularity in oral surgery and periodontal procedures (12) with evidence suggesting faster mucosal healing and reduced post-operative complications, because of a slower, continuous release of growth factors when compared to other concentrates in vitro. Furthermore, the leukocytes presented in L-PRF may synthesize several pro- and anti-inflammatory cytokines as well.

However, controlled data on its use specifically for ORN or MRONJ prevention is scarce. Small case series and observational studies suggest improved outcomes, but robust trial data is lacking.

Given the significant morbidity associated with ORN and MRONJ and the lack of proven preventive strategies, evaluating L-PRF in a clinical trial setting is justified. The intervention is autologous and low-risk. Potential benefits include enhanced mucosal healing and reduced incidence of osteonecrosis. Risks are minimal and largely relate to venepuncture or standard surgical procedures. The trial aims to determine feasibility, safety, and early efficacy signals to inform future large-scale trials.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

-General Inclusion Criteria (Applies to All Participants)

Age ≥18 years

Requiring extraction of one or more teeth with hopeless prognosis

Capacity to provide informed consent

Ability and willingness to attend all scheduled follow-up visits over 12 months

-Post-Radiotherapy Group - Specific Inclusion

Previous radiotherapy to the head and neck region

Documented radiation dose ≥50 Gy

Radiotherapy records (dose, field, date) must be available

-Antiresorptive Group - Specific Inclusion

Current or prior use of antiresorptive agents (e.g. bisphosphonates or denosumab)

Medication history must be available in medical records

Exclusion Criteria:

  • General Exclusion Criteria (Applies to All Participants)

Inability to maintain adequate oral hygiene due to motor disability

Uncontrolled systemic illness (e.g. uncontrolled diabetes)

Use of anticoagulants, immunosuppressants, or medications known to impair healing

Requirement for surgical (complex) extractions

Enrolment in another clinical trial

Known allergy to anaesthetic agents, L-PRF components, or antibiotics used in perioperative protocol

Anticipated non-compliance with follow-up

-Post-Radiotherapy Group - Specific Exclusion

Previous or current antiresorptive therapy

History of re-irradiation or radiation dose <50 Gy

-Antiresorptive Group - Specific Exclusion

History of head and neck radiotherapy

Neoplastic involvement of the jaws

Active untreated oral infection or pathology at time of planned extraction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
Other: Standard Extraction
No L-PRF will be placed in the post-extraction sockets
Experimental: L-PRF Group: Tooth socket will be treated with Platelet-Rich Fibrin (L-PRF)
Other: L-PRF
L-PRF is made from the patient's own blood and contains natural healing cells and growth factors. It is already used in other areas of dentistry to help wounds heal, but it is not yet clear whether it helps prevent jawbone necrosis in patients with a history of radiotherapy for head and cancers, or in patients taking antiresorptive medications. This study will help us understand whether using L-PRF during extractions makes healing faster and safer and can can prevent or reduce the chance of developing osteoradionecrosis or MRONJ in patients with a history of radiotherapy for head and cancers, or in patients taking antiresorptive medications respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mucosal healing of the dental extraction, assessed using the Landry Wound Healing Index.
Time Frame: Day !0
Day !0

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of ORN and MRONJ at the extraction sites
Time Frame: assessed at 9, 17, 25 weeks and 12 months post-extraction.
assessed at 9, 17, 25 weeks and 12 months post-extraction.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swansea Bay University Health Board

Investigators

  • Study Chair: Ketan R Shah, FRCS, Swansea Bay University Health Board

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 2, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SBU62

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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