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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSwansea Bay University Health Board

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

General Exclusion Criteria (Applies to All Participants)

Trial design

Design model

Parallel

Treatments tested in this trial

  • L-PRF

    Other intervention

    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.

  • Standard Extraction

    Other intervention

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: L-PRF Group: Tooth socket will be treated with Platelet-Rich Fibrin (L-PRF)Experimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mucosal healing of the dental extraction, assessed using the Landry Wound Healing Index.

Time frame
Day !0

Secondary outcomes

1

Incidence of ORN and MRONJ at the extraction sites

Time frame
assessed at 9, 17, 25 weeks and 12 months post-extraction.

Other outcomes

Sponsors and contacts

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