[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteoradionecrosis-of-the-jaw\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteoradionecrosis-of-the-jaw":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100651726","impacted-tooth-management-and-osteoradionecrosis-risk-in-npc-100651726",false,"NCT07764887","Impacted Tooth Management and Osteoradionecrosis Risk in NPC","Omission of Prophylactic Impacted Tooth Extraction and Risk of Jaw Osteoradionecrosis in Nasopharyngeal Carcinoma: A Multicenter, Noninferiority, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Age 18-75 years, regardless of sex.\n* Histologically confirmed non-keratinizing nasopharyngeal carcinoma, including differentiated or undifferentiated subtype (WHO type II or III).\n* Newly diagnosed, previously untreated nasopharyngeal carcinoma with stage T1-4N0-3M0 according to the 9th edition of the American Joint Committee on Cancer\u002FUnion for International Cancer Control (AJCC\u002FUICC) staging system.\n* Presence of permanent dentition with at least one impacted third molar.\n* Adequate bone marrow function, defined as white blood cell count ≥4.0 × 10⁹\u002FL, platelet count ≥100 × 10⁹\u002FL, and hemoglobin ≥90 g\u002FL.\n* Adequate hepatic function, defined as alanine aminotransferase and aspartate aminotransferase ≤2.5 × the upper limit of normal (ULN), and total bilirubin ≤1.5 × ULN.\n* Adequate renal function, defined as blood urea nitrogen and serum creatinine ≤1.5 × ULN, or creatinine clearance ≥60 mL\u002Fmin.\n* Coagulation function within normal limits.\n* Written informed consent provided, with willingness and ability to comply with study visits, treatment plans, laboratory assessments, and other study procedures.\n\nExclusion Criteria:\n\n* Histopathological diagnosis other than WHO type II or III nasopharyngeal carcinoma.\n* Impacted third molars with recurrent pericoronitis or inflammation due to incomplete eruption.\n* Fully erupted third molars with dental caries involving the pulp.\n* Impacted third molars with radiographic evidence of periapical or periodontal inflammation.\n* Third molars completely impacted within the jawbone.\n* History of active malignancy or other malignant tumors diagnosed within the previous 5 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ.\n* Previous chemotherapy, surgery (except diagnostic procedures), radiotherapy, or other antitumor treatment for nasopharyngeal carcinoma or cervical lesions.\n* Patients receiving palliative treatment.\n* Pregnant or breastfeeding women.\n* Severe uncontrolled cardiovascular or cerebrovascular diseases.\n* Severe hepatic or renal dysfunction.\n* Uncontrolled diabetes mellitus.\n* Severe osteoporosis, medication-related osteonecrosis\u002Fosteomyelitis, or chronic diseases requiring long-term systemic corticosteroid therapy.\n* Other severe chronic debilitating diseases that may increase study risk or affect study compliance.\n* History of drug abuse or alcohol dependence.\n* Uncontrolled psychiatric disorders or inability to provide legally valid informed consent.\n* Positive hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \\>1,000 copies\u002FmL.\n* Active hepatitis C virus infection (positive HCV RNA).\n* Human immunodeficiency virus (HIV) infection or diagnosis of acquired immunodeficiency syndrome (AIDS).\n* Active tuberculosis within the previous 1 year.\n* History of active tuberculosis more than 1 year previously without documented completion of standard anti-tuberculosis treatment.\n* Any other medical, psychological, social, or laboratory condition that, in the investigator's judgment, may compromise participant safety, interfere with study procedures, affect protocol compliance, or result in premature withdrawal from the study.\n* Refusal or inability to provide written informed consent.","ALL","18 Years","75 Years",{"count":20,"type":21},536,"ESTIMATED","INTERVENTIONAL",[24],"NA","This multicenter, randomized controlled trial is designed to determine whether omitting prophylactic extraction of impacted teeth before radiotherapy leads to an unacceptably higher risk of jaw osteoradionecrosis (JORN) compared with conventional prophylactic extraction in patients with non-metastatic nasopharyngeal carcinoma (NPC). JORN is a condition in which jawbone tissue is damaged and fails to heal properly after radiotherapy.\n\nA total of 536 eligible participants with at least one impacted tooth will be randomly assigned to either omit prophylactic extraction of impacted teeth before radiotherapy or undergo conventional prophylactic extraction before radiotherapy. All participants will receive standard curative-intent intensity-modulated radiotherapy (IMRT), with chemotherapy administered when indicated according to the study protocol.\n\nParticipants will be followed for up to 5 years. The primary outcome is the incidence of JORN within 2 years after completion of radiotherapy. Secondary outcomes include longer-term incidence of JORN, overall survival, locoregional relapse-free survival, distant metastasis-free survival, quality of life, and treatment-related toxicities.",[27,28],"Nasopharyngeal Carcinoma (NPC)","Osteoradionecrosis of the Jaw",[30,31,32,33,34],"Nasopharyngeal carcinoma","Jaw osteoradionecrosis","Impacted tooth","Prophylactic tooth extraction","Intensity-modulated radiotherapy","NOT_YET_RECRUITING","2026-08-10",{"date":38,"type":39},"2026-08-14","ACTUAL",{"date":41,"type":21},"2026-08-30",{"date":43,"type":21},"2032-11-30",{"name":45,"class":46},"First Affiliated Hospital of Guangxi Medical University","OTHER",11,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100638024","l-prf-in-prevention-of-orn-and-mronj-following-tooth-extractionsv30-100638024","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,{"count":57,"type":21},40,[24],"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.",[28,61],"Medicine Related Osteonecrosis of the Jaw",[63],"L-PRF, ORN, MRONJ","2026-05-06",{"date":66,"type":39},"2026-05-13",{"date":68,"type":21},"2026-08-02",{"date":70,"type":21},"2028-07-31",{"name":72,"class":46},"Swansea Bay University Health Board",1]