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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07585123
Enrollment
40
Registered
2026-05-13
Start date
2026-08-02
Completion date
2028-07-31
Last updated
2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoradionecrosis of the Jaw, Medicine Related Osteonecrosis of the Jaw

Keywords

L-PRF, ORN, MRONJ

Brief summary

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.

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.

Interventions

OTHERL-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.

No L-PRF will be placed in the post-extraction sockets

Sponsors

Swansea Bay University Health Board
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Mucosal healing of the dental extraction, assessed using the Landry Wound Healing Index.Day !0

Secondary

MeasureTime frame
Incidence of ORN and MRONJ at the extraction sitesassessed at 9, 17, 25 weeks and 12 months post-extraction.

Countries

United Kingdom

Contacts

CONTACTPartha S Chakraborty
Partha.Chakraborty@wales.nhs.uk+44 7867063718
STUDY_CHAIRKetan R Shah, FRCS

Swansea Bay University Health Board

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026