[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"medication-related-osteonecrosis-of-the-jaw-mronj\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:medication-related-osteonecrosis-of-the-jaw-mronj":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100646300","early-warning-and-risk-prediction-of-medication-related-osteonecrosis-of-the-jaw-100646300",false,"NCT07691892","Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw","Development and Validation of a Multimodal Risk Prediction Model for Medication-Related Osteonecrosis of the Jaw: A Prospective Cohort Study.","Inclusion Criteria:\n\n1. Adults aged 18 to 70 years, regardless of sex.\n2. Currently receiving bone-modifying agents, including bisphosphonates or denosumab, for osteoporosis or bone metastases.\n3. Continuous use of bone-modifying agents for at least 24 months before enrollment.\n4. Scheduled to undergo clinically indicated invasive oral procedures, including root canal therapy, periapical surgery, tooth extraction, periodontal scaling and root planing, periodontal surgery, or other invasive oral procedures as clinically needed.\n5. No clinical signs of medication-related osteonecrosis of the jaw before the planned oral procedure, according to the diagnostic criteria of the American Association of Oral and Maxillofacial Surgeons.\n6. Able to understand the study purpose and procedures and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Previously diagnosed or suspected medication-related osteonecrosis of the jaw.\n2. Other diseases or conditions that may cause osteonecrosis of the jaw, such as osteoradionecrosis or malignant tumors of the jaw.\n3. Severe coagulation disorders or active bleeding disorders that preclude invasive oral procedures.\n4. Severe cardiac, hepatic, or renal dysfunction, including New York Heart Association class III-IV heart failure, Child-Pugh class C liver disease, or renal failure requiring dialysis.\n5. Autoimmune disease or current immunosuppressive therapy that may affect bone metabolism or immune status assessment.\n6. Salivary gland dysfunction, such as Sjögren's syndrome, that may affect the quality of saliva sample collection.\n7. Pregnancy or breastfeeding.\n8. Psychiatric disorders or cognitive impairment that would prevent understanding of the study procedures or compliance with follow-up.\n9. Uncontrolled hypertension or diabetes mellitus, or a history of stroke or transient ischemic attack within the past 6 months.\n10. Use of any vaccine for the prevention of infectious diseases, such as influenza or varicella vaccine, within 4 weeks before enrollment.\n11. Congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis B or hepatitis C infection. Active hepatitis B is defined as HBV DNA above the upper limit of normal, and active hepatitis C is defined as HCV viral titer or RNA above the upper limit of normal.\n12. Participation in another clinical study that may interfere with the results of this study.","ALL","18 Years","70 Years",{"count":20,"type":21},310,"ESTIMATED","12 Months","OBSERVATIONAL","This prospective observational cohort study aims to develop and evaluate an early warning and risk prediction model for medication-related osteonecrosis of the jaw (MRONJ) based on multimodal data fusion.\n\nEligible participants will include adults who have received bone-modifying agents, including bisphosphonates or denosumab, for at least 24 months for osteoporosis or bone metastases and who are scheduled to undergo clinically indicated invasive oral procedures. The study will not assign any treatment or intervention. All oral procedures will be performed as part of routine clinical care.\n\nClinical characteristics, medication exposure, oral examination findings, cone-beam computed tomography imaging data, and biological samples including saliva, blood, urine, and gingival crevicular fluid will be collected. Proteomic and metabolomic analyses will be performed to identify candidate biomarkers associated with MRONJ risk.\n\nParticipants will be followed prospectively after the oral procedure to assess wound healing, clinical symptoms, imaging changes, and the occurrence of MRONJ. The study will evaluate whether a multimodal model combining clinical, imaging, and biological data can predict the risk of MRONJ after invasive oral procedures.",[26],"Medication-related Osteonecrosis of the Jaw (MRONJ)",[28,29,30,31,32,33,34,35,36,37],"medication-related osteonecrosis of the jaw (MRONJ)","Bone-modifying agents","Bisphosphonates","Denosumab","Invasive oral procedures","Risk prediction","Multimodal data fusion","Proteomics","Metabolomics","Biomarkers","NOT_YET_RECRUITING","2026-07-02",{"date":41,"type":42},"2026-07-09","ACTUAL",{"date":44,"type":21},"2026-08-01",{"date":46,"type":21},"2030-09-01",{"name":48,"class":49},"Hospital of Stomatology, Wuhan University","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100500391","phase-2-the-pento-protocol-in-medication-related-osteonecrosis-of-the-jaw-100500391","NCT05795647","The PENTO Protocol in Medication-related Osteonecrosis of the Jaw","PENTO","Inclusion Criteria:\n\n* Age greater than or equal to 18 years\n* Current or past treatment with bisphosphonates (oral or IV) and\u002For targeted therapies (denosumab, bevacizumab)\n* Signs and symptoms for more than 8S with confirmation that the signs and symptoms are not of dental origin\n* AAOMS Stage 2 MRONJ\n* For patients of childbearing age, effective contraception is required\n\nExclusion Criteria:\n\n* History of head or neck radiotherapy or maxilla metastases\n* Patients who have received treatment in the past (PENTO or PENTOCLO protocol)\n* Patients who have undergone surgery for their MRONJ within the last 3 months\n* Pregnant or wishing to be pregnant, breastfeeding\n* Patient under palliative care\n* Patient with hypersensitivity to pentoxifylline or tocopherol or to an excipient\n* History of hypersensitivity reaction to penicillins, cephalosporins, or other beta-lactams (and clindamycin or lincomycin if applicable) or excipient of amoxicillin-a. clavulanic or clindamycin\n* History of jaundice\u002Fhepatic injury related to amoxicillin\u002Fclavulanic acid\n* Patient taking oral anticoagulants, or with a history of major bleeding or bleeding disorders\n* Patient taking platelet aggregation inhibitor, theophylline or aminophylline\n* Patient taking methotrexate, probenecid, mycophenolate mofetil, myorelaxant drugs, macrolide or streptogramin antibiotics\n* Patients with hepatic failure or renal failure (Cl \\\u003C 30 mL\u002Fmin),\n* Patient with hypotension (SBP \\\u003C 90 mmHg)\n* Refusal to participate in the study\n* Patient participating in other interventional research that may interfere with the conduct of this research\n* Patient unable to understand the protocol\n* Patient under curatorship or guardianship",{"count":58,"type":21},17,"INTERVENTIONAL",[61],"PHASE2","Medication-related osteonecrosis of the jaw (MRONJ) occurs after taking bisphosphonates or targeted therapies. It leads to a significant decrease in quality of life with pain, eating and chewing disorders, and malnutrition. Current treatments are only partially effective. PENTO (pentoxifylline and tocopherol) has been shown to be effective in maxillary osteoradionecrosis. The objective of this study is to evaluate the proportion of bone recovery in patients receiving PENTO in MRONJ at 12 months.",[26],[65,66,67,68,69],"MRONJ","pentoxifylline","tocophérol","bone exposure","renutrition","RECRUITING","2026-06-23",{"date":73,"type":42},"2026-06-24",{"date":75,"type":42},"2024-02-29",{"date":77,"type":21},"2028-04-07",{"name":79,"class":49},"University Hospital, Limoges",1]