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.
Study Type
OBSERVATIONAL
Enrollment
310
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.
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.
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.
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.