[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657305":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":38,"studyPopulation":42,"armGroups":43,"interventions":38,"overallOfficials":50,"centralContacts":55,"locations":38,"responsibleParty":61,"collaborators":38,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":38,"enrollmentInfo":73,"targetDuration":38,"studyType":76,"phases":38,"briefSummary":77,"conditions":78,"keywords":38,"overallStatus":84,"whyStopped":38,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":38},{"fullName":5,"class":6},"AO Innovation Translation Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Development of osteoradionecrosis (ORN) of the jaw","The primary outcome is the development occurrence (yes\u002Fno) of ORN after completion of pre- and\u002For postoperative RT. The objective is to identify and evaluate patient-, tumor-, treatment-, and region-related risk factors associated with the development of ORN across multiple geographic regions.\n\nScoring Scale:\n\nThe primary endpoint will be treated as a binary variable:\n\n0 = No ORN\n\n1 = Development of ORN Time to ORN onset (interval between completion of RT and clinical diagnosis of ORN) will also be recorded for time-to-event analyses.","After completion of pre-and\u002For postoperative radiotherapy up to 24 months",[14,17,20,23,26,29,31,34,36],{"measure":15,"description":16,"timeFrame":12},"Incidence of ORN Across Geographic Regions","To compare the incidence rates across geographical regions, namely between the Eastern and Western world, and High-Income Countries versus Low and Middle-Income Countries.",{"measure":18,"description":19,"timeFrame":12},"Severity of ORN by Tumor Characteristic","To evaluate the variability in the severity of osteoradionecrosis (ORN) based on primary tumor site (eg, tongue, floor of mouth, oral tongue, buccal mucosa, gingiva), histological tumor type (eg, adenoid cystic carcinoma, squamous cell carcinoma), and tumor characteristics including size, clinical stage (T1-T4), overall stage (III-IVA), and nodal status (N0, N1-2B, N2C, N3",{"measure":21,"description":22,"timeFrame":12},"Association between radiotherapy dose and ORN severity","To investigate the association between radiotherapy dose parameters (total dose and duration) and the severity grade of ORN among patients who develop ORN. Is there a correlation between increased radiation dose and duration and the severity of the condition?",{"measure":24,"description":25,"timeFrame":12},"Incidence and severity comparison of preop vs. postop RT","To compare the incidence and severity of ORN in patients undergoing preoperative versus postoperative radiotherapy",{"measure":27,"description":28,"timeFrame":12},"Incidence comparison across RT modalities","To compare the incidence ORN across different radiation modalities, including intensity-modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT), and conventional three-dimensional conformal radiotherapy (3D-CRT)",{"measure":30,"description":30,"timeFrame":12},"To determine whether the mandible is more susceptible to ORN than the maxilla, or vice versa.",{"measure":32,"description":33,"timeFrame":12},"Complication evaluation with pre- or postop RT","To evaluate potential complications associated with preoperative and postoperative radiotherapy",{"measure":35,"description":35,"timeFrame":12},"To analyze the influence of pre-radiotherapy dental extractions and oral hygiene status on the risk of developing ORN",{"measure":37,"description":37,"timeFrame":12},"To examine the variability in ORN incidence and severity between patients who undergo dental extractions before versus after the completion of RT",null,{"allocation":38,"interventionModel":38,"interventionModelDescription":38,"primaryPurpose":38,"observationalModel":40,"timePerspective":41,"maskingInfo":38},"COHORT","RETROSPECTIVE","Patients will be selected from the primary care center where the patients received their initial treatment and followed up for at least 24months",[44,47],{"label":45,"type":38,"description":46,"interventionNames":38},"Cases (ORN group)","Developed clinically and radiographically or histologically confirmed osteoradionecrosis (ORN) of the jaw following radiotherapy.",{"label":48,"type":38,"description":49,"interventionNames":38},"Control (non-ORN group)","No clinical, radiological, or histological diagnosis of ORN during the follow-up period.",[51],{"name":52,"affiliation":53,"role":54},"Khalid Abdel-Galil, MD","Hamad Medical Corporation PO Box 3050 Doha, Qatar","PRINCIPAL_INVESTIGATOR",[56],{"name":57,"role":58,"phone":59,"phoneExt":38,"email":60},"Benjamin Bretzinger","CONTACT","+41 81 414 21 11","benjamin.bretzinger@aofoundation.org",{"type":62,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100657305","risk-factors-of-jaw-osteoradionecrosis-in-oral-cavity-cancer-patients-post-radiotherapy-100657305",false,"NCT07836829","Risk Factors of Jaw Osteoradionecrosis in Oral Cavity Cancer Patients Post-Radiotherapy","Risk Factors of Jaw Osteoradionecrosis in Oral Cavity Cancer Patients Post-Radiotherapy: A Multi-center Retrospective Cohort Study","AOITC","Inclusion Criteria:\n\n* Adults (≥18 years) diagnosed with OCC and treated with radiotherapy with curative intent (preoperative or\u002Fand postoperative, not palliative; definitive RT)\n* Patients who completed the full prescribed radiotherapy course; patients remain eligible if radiotherapy was discontinued due to suspected and subsequently confirmed ORN\n* Available, complete medical records including RT details, oral status, comorbidities, dental procedure details (as applicable), and lifestyle factors (as applicable)\n* Documented informed consent from the treated patient, where applicable, permitting the use of their medical records for research purposes, in accordance with the requirements of the Institutional Review Board (IRB) or Ethics Committee (EC).\n* Availability of at least 24 months of follow-up data after completion of radiotherapy, or follow-up until the occurrence of ORN, death, or loss to follow-up, whichever occurs first.\n* Completion of the radiotherapy course on or before 31 December 2024.\n\nExclusion Criteria:\n\n* Patients with non-oral cavity primary cancers (eg, oropharynx, larynx)\n* Patients treated only with surgery or conservatively, without any form of RT\n* Incomplete or missing medical records\n* Record of use of antiresorptive (eg, bisphosphonate, denosumab) and antiangiogenic drugs\n* Patients with jaw necrosis attributable to non-radiation-related causes, such as medication-related osteonecrosis of the jaw (MRONJ), trauma, or odontogenic infections\n* Patients with known metastatic bone disease in the jaw\n* Patients who discontinued radiotherapy for reasons unrelated to ORN suspicion or confirmation (eg, death, dropout, treatment intolerance, or other non-ORN related causes)","ALL","18 Years",{"count":74,"type":75},1000,"ESTIMATED","OBSERVATIONAL","Osteoradionecrosis (ORN) of the jaw is a serious complication that can occur after radiation therapy for head and neck cancers, including oral cavity cancer (OCC). ORN happens when jawbone tissue dies and fails to heal, often triggered by dental issues like tooth extractions or poorly fitting dentures. Symptoms can include exposed bone, pain, difficulty opening the mouth, trouble swallowing, and even jaw fractures-leading to major physical and emotional challenges.\n\nThe likelihood of ORN varies widely, from less than 1% to over 50% in head and neck cancer patients. For OCC specifically, studies report rates from 4% up to 25%. Treatment depends on how much bone is affected and can range from medication to major surgery.\n\nRisk factors include radiation dose, tumor location, oral health, dental extractions, lifestyle habits (like alcohol use), and other health conditions. Poor oral hygiene, high radiation doses, and alcohol use are among the most common risks. However, current data on OCC patients is limited and often not broadly applicable.\n\nThis study will retrospectively examine what increases the risk of ORN in OCC patients who received radiation therapy before or after surgery. Using data from multiple international centers, it aims to identify patterns and provide globally relevant insights. The results will help guide prevention strategies and create evidence-based guidelines to reduce ORN and improve long-term outcomes for these patients.",[79,80,81,82,83],"Osteoradionecrosis","Radiotherapy","Risk Factors","Oral Cancer","Oral Cavity Cancer","NOT_YET_RECRUITING","2026-09-17",{"date":87,"type":88},"2026-09-23","ACTUAL",{"date":90,"type":75},"2027-03-01",{"date":92,"type":75},"2029-07-15",{"name":5,"class":6}]