[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651726":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":190,"collaborators":193,"id":209,"slug":210,"hasResults":211,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":25,"eligibilityCriteria":215,"healthyVolunteers":211,"sex":216,"minAge":217,"maxAge":218,"enrollmentInfo":219,"targetDuration":25,"studyType":222,"phases":223,"briefSummary":225,"conditions":226,"keywords":229,"overallStatus":235,"whyStopped":25,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":245},{"fullName":5,"class":6},"First Affiliated Hospital of Guangxi Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Omission of Prophylactic Extraction Group","EXPERIMENTAL","Participants assigned to this group will not undergo prophylactic extraction of impacted teeth before radiotherapy.",[13],"Other: Omission of Prophylactic Impacted Tooth Extraction",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Prophylactic Extraction Group","ACTIVE_COMPARATOR","Participants assigned to this group will undergo conventional prophylactic extraction of impacted teeth before radiotherapy.",[19],"Procedure: Prophylactic Impacted Tooth Extraction",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Omission of Prophylactic Impacted Tooth Extraction","Participants will not undergo prophylactic extraction of eligible impacted teeth before radiotherapy.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"PROCEDURE","Prophylactic Impacted Tooth Extraction","Participants will undergo prophylactic extraction of eligible impacted teeth before radiotherapy according to the study protocol.",[15],[32],{"name":33,"affiliation":5,"role":34},"Min Kang, MD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Li Jiang, MD","CONTACT","+86 15994349883","jiangli@sr.gxmu.edu.cn",{"name":42,"role":38,"phone":43,"phoneExt":25,"email":44},"Zhen Meng, MD","+86 15578301825","mengzhen0307@163.com",[46,64,78,92,106,120,131,145,153,164,178],{"facility":47,"status":25,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Affiliated Hospital of Youjiang Medical University for Nationalities","Baise City","Guangxi","533000","China","CN",{"type":54,"coordinates":55},"Point",[56,57],106.62684,23.89013,{"lat":57,"lon":56},[60],{"name":61,"role":38,"phone":62,"phoneExt":25,"email":63},"Tingzhuang Yi, MD","+86 776-2802090","ytz20070101@163.com",{"facility":65,"status":25,"city":66,"state":49,"zip":67,"country":51,"countryCode":52,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Beihai People's Hospital","Beihai","536000",{"type":54,"coordinates":69},[70,71],109.11549,21.48349,{"lat":71,"lon":70},[74],{"name":75,"role":38,"phone":76,"phoneExt":25,"email":77},"Sihui Liao, MD","+86 779 2023316","13507799365@136.com",{"facility":79,"status":25,"city":80,"state":49,"zip":81,"country":51,"countryCode":52,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Guigang People's Hospital","Guigang","537100",{"type":54,"coordinates":83},[84,85],109.59472,23.11603,{"lat":85,"lon":84},[88],{"name":89,"role":38,"phone":90,"phoneExt":25,"email":91},"Yan Wei, MD","+86 15678865869","wyan184@163.com",{"facility":93,"status":25,"city":94,"state":49,"zip":95,"country":51,"countryCode":52,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"The Affiliated Hospital of Guilin Medical University","Guilin","541001",{"type":54,"coordinates":97},[98,99],110.29639,25.28022,{"lat":99,"lon":98},[102],{"name":103,"role":38,"phone":104,"phoneExt":25,"email":105},"Xin Zhang, MD","+86 773 2833086","zhangxin1262008@126.com",{"facility":107,"status":25,"city":108,"state":49,"zip":109,"country":51,"countryCode":52,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Liuzhou People's Hospital","Liuzhou","545006",{"type":54,"coordinates":111},[112,113],109.40698,24.32405,{"lat":113,"lon":112},[116],{"name":117,"role":38,"phone":118,"phoneExt":25,"email":119},"Jingchang Li, MD","+86 18078259868","549026160@qq.com",{"facility":121,"status":25,"city":108,"state":49,"zip":122,"country":51,"countryCode":52,"cosmosGeoPoint":123,"geoPoint":125,"contacts":126},"Liuzhou Workers' Hospital","545007",{"type":54,"coordinates":124},[112,113],{"lat":113,"lon":112},[127],{"name":128,"role":38,"phone":129,"phoneExt":25,"email":130},"Ying Lu, MD","+86 772 3815405","1786734840@qq.com",{"facility":132,"status":25,"city":133,"state":49,"zip":134,"country":51,"countryCode":52,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"The People's Hospital of Guangxi Zhuang Autonomous Region","Nanning","530000",{"type":54,"coordinates":136},[137,138],108.31667,22.81667,{"lat":138,"lon":137},[141],{"name":142,"role":38,"phone":143,"phoneExt":25,"email":144},"Heming Lu, MD","+860771-5722416","luhming3632@163.com",{"facility":146,"status":25,"city":133,"state":49,"zip":147,"country":51,"countryCode":52,"cosmosGeoPoint":148,"geoPoint":150,"contacts":151},"The First Affiliated Hospital of Guangxi Medical University","530021",{"type":54,"coordinates":149},[137,138],{"lat":138,"lon":137},[152],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"facility":154,"status":25,"city":133,"state":49,"zip":155,"country":51,"countryCode":52,"cosmosGeoPoint":156,"geoPoint":158,"contacts":159},"Wuming Hospital Affiliated to Guangxi Medical University","530199",{"type":54,"coordinates":157},[137,138],{"lat":138,"lon":137},[160],{"name":161,"role":38,"phone":162,"phoneExt":25,"email":163},"Weiming Zhang, MS","+86 771-6363880","weiming8207@163.com",{"facility":165,"status":25,"city":166,"state":49,"zip":167,"country":51,"countryCode":52,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Wuzhou Red Cross Hospital","Wuzhou","543002",{"type":54,"coordinates":169},[170,171],111.28848,23.48054,{"lat":171,"lon":170},[174],{"name":175,"role":38,"phone":176,"phoneExt":25,"email":177},"Jianquan Gao, MD","+86 774 3827268","wzhh13878480321@163.com",{"facility":179,"status":25,"city":180,"state":49,"zip":181,"country":51,"countryCode":52,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"The First People's Hospital of Yulin","Yulin","537000",{"type":54,"coordinates":183},[184,185],110.14686,22.6305,{"lat":185,"lon":184},[188],{"name":189,"role":38,"phone":25,"phoneExt":25,"email":25},"Leifeng Liang, MD",{"type":34,"investigatorFullName":191,"investigatorTitle":192,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"min kang","Director of Radiation Oncology Department, The First Affiliated Hospital of Guangxi Medical University",[194,196,198,200,201,202,204,207],{"name":195,"class":6},"People's Hospital of Guangxi Zhuang Autonomous Region",{"name":197,"class":6},"LiuZhou People's Hospital",{"name":121,"class":199},"OTHER_GOV",{"name":165,"class":6},{"name":79,"class":6},{"name":203,"class":6},"First People's Hospital of Yulin",{"name":205,"class":206},"Affiliated Hospital of Guilin University","UNKNOWN",{"name":208,"class":6},"Youjiang Medical College for Nationalities","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":220,"type":221},536,"ESTIMATED","INTERVENTIONAL",[224],"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.",[227,228],"Nasopharyngeal Carcinoma (NPC)","Osteoradionecrosis of the Jaw",[230,231,232,233,234],"Nasopharyngeal carcinoma","Jaw osteoradionecrosis","Impacted tooth","Prophylactic tooth extraction","Intensity-modulated radiotherapy","NOT_YET_RECRUITING","2026-08-10",{"date":238,"type":239},"2026-08-14","ACTUAL",{"date":241,"type":221},"2026-08-30",{"date":243,"type":221},"2032-11-30",{"name":5,"class":6},11]