[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638024":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":55,"collaborators":11,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":11,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":11,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":79,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Swansea Bay University Health Board","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"L-PRF Group: Tooth socket will be treated with Platelet-Rich Fibrin (L-PRF)","EXPERIMENTAL",null,[13],"Other: L-PRF",{"label":15,"type":16,"description":11,"interventionNames":17},"Control Group","PLACEBO_COMPARATOR",[18],"Other: Standard Extraction",[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"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.",[9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Standard Extraction","No L-PRF will be placed in the post-extraction sockets",[15],[29],{"name":30,"affiliation":5,"role":31},"Ketan R Shah, FRCS","STUDY_CHAIR",[33],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"Partha S Chakraborty","CONTACT","+44 7867063718","Partha.Chakraborty@wales.nhs.uk",[39],{"facility":40,"status":11,"city":41,"state":11,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Morriston Hospital","Swansea","SA6 6NL","United Kingdom","UK",{"type":46,"coordinates":47},"Point",[48,49],-3.94323,51.62079,{"lat":49,"lon":48},[52,53],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},{"name":34,"role":54,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":56,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100638024","l-prf-in-prevention-of-orn-and-mronj-following-tooth-extractionsv30-100638024",false,"NCT07585123","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","Inclusion Criteria:\n\n-General Inclusion Criteria (Applies to All Participants)\n\nAge ≥18 years\n\nRequiring extraction of one or more teeth with hopeless prognosis\n\nCapacity to provide informed consent\n\nAbility and willingness to attend all scheduled follow-up visits over 12 months\n\n-Post-Radiotherapy Group - Specific Inclusion\n\nPrevious radiotherapy to the head and neck region\n\nDocumented radiation dose ≥50 Gy\n\nRadiotherapy records (dose, field, date) must be available\n\n-Antiresorptive Group - Specific Inclusion\n\nCurrent or prior use of antiresorptive agents (e.g. bisphosphonates or denosumab)\n\nMedication history must be available in medical records\n\nExclusion Criteria:\n\n* General Exclusion Criteria (Applies to All Participants)\n\nInability to maintain adequate oral hygiene due to motor disability\n\nUncontrolled systemic illness (e.g. uncontrolled diabetes)\n\nUse of anticoagulants, immunosuppressants, or medications known to impair healing\n\nRequirement for surgical (complex) extractions\n\nEnrolment in another clinical trial\n\nKnown allergy to anaesthetic agents, L-PRF components, or antibiotics used in perioperative protocol\n\nAnticipated non-compliance with follow-up\n\n-Post-Radiotherapy Group - Specific Exclusion\n\nPrevious or current antiresorptive therapy\n\nHistory of re-irradiation or radiation dose \\\u003C50 Gy\n\n-Antiresorptive Group - Specific Exclusion\n\nHistory of head and neck radiotherapy\n\nNeoplastic involvement of the jaws\n\nActive untreated oral infection or pathology at time of planned extraction",true,"ALL","18 Years",{"count":68,"type":69},40,"ESTIMATED","INTERVENTIONAL",[72],"NA","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.\n\nWhile 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.",[75,76],"Osteoradionecrosis of the Jaw","Medicine Related Osteonecrosis of the Jaw",[78],"L-PRF, ORN, MRONJ","NOT_YET_RECRUITING","2026-05-06",{"date":82,"type":83},"2026-05-13","ACTUAL",{"date":85,"type":69},"2026-08-02",{"date":87,"type":69},"2028-07-31",{"name":5,"class":6},1]