Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorHospital of Stomatology, Wuhan University
About this trial
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.
Eligible 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.
Clinical 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.
Participants 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 70 years, regardless of sex.
Currently receiving bone-modifying agents, including bisphosphonates or denosumab, for osteoporosis or bone metastases.
Continuous use of bone-modifying agents for at least 24 months before enrollment.
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.
Disqualifiers
Previously diagnosed or suspected medication-related osteonecrosis of the jaw.
Other diseases or conditions that may cause osteonecrosis of the jaw, such as osteoradionecrosis or malignant tumors of the jaw.
Severe coagulation disorders or active bleeding disorders that preclude invasive oral procedures.
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.
Trial population
Patients at risk of medication-related osteonecrosis of the jaw will be prospectively recruited from the School \& Hospital of Stomatology, Wuhan University. Eligible participants will include adults with a history of antiresorptive or antiangiogenic medication exposure who require oral and maxillofacial evaluation, dental treatment, or follow-up. Clinical, imaging, laboratory, and follow-up data will be collected to develop and evaluate an early warning and risk prediction model for medication-related osteonecrosis of the jaw.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
310 Participants
are grouped into 1 trial groupGroup A: MRONJ risk cohort
Trial outcomes
Primary outcomes
1
Incidence of medication-related osteonecrosis of the jaw within 12 months after the invasive oral procedure.
The occurrence of medication-related osteonecrosis of the jaw will be assessed according to the diagnostic criteria of the American Association of Oral and Maxillofacial Surgeons. Clinical examination and cone-beam computed tomography will be used to determine whether participants develop medication-related osteonecrosis of the jaw during follow-up.
Time frame
12 months after the invasive oral procedure.Secondary outcomes
1
Area under the receiver operating characteristic curve of the multimodal prediction model for medication-related osteonecrosis of the jaw.
The area under the receiver operating characteristic curve (AUC) will be used to evaluate the discrimination performance of a multimodal early warning and risk prediction model for medication-related osteonecrosis of the jaw. The model will integrate clinical characteristics, medication exposure, oral examination findings, cone-beam computed tomography imaging features, and proteomic and metabolomic biomarkers from body fluid samples.
Time frame
3 months, 6 months, 12 months after the invasive oral procedure.2
Sensitivity and specificity of the multimodal prediction model for medication-related osteonecrosis of the jaw.
Sensitivity and specificity will be calculated as the proportion of participants who do not develop medication-related osteonecrosis of the jaw and are correctly classified as low risk by the multimodal prediction model.
Time frame
3 months, 6 months, 12 months after the invasive oral procedure.3
Early clinical manifestations and progression patterns of medication-related osteonecrosis of the jaw.
Early clinical manifestations and progression patterns will be assessed based on wound healing, pain, swelling, suppuration, numbness, bone exposure, fistula formation, and cone-beam computed tomography findings during follow-up.
Time frame
1 week, 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after the invasive oral procedure.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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