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 volunteersQualifiers
None
Disqualifiers
General Exclusion Criteria (Applies to All Participants)
Trial design
Parallel
Treatments tested in this trial
L-PRF
Other interventionL-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 interventionNo L-PRF will be placed in the post-extraction sockets
Treatment groups
Trial outcomes
Primary outcomes
Mucosal healing of the dental extraction, assessed using the Landry Wound Healing Index.
Secondary outcomes
Incidence of ORN and MRONJ at the extraction sites
Sponsors and contacts
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