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NOT YET RECRUITING
NCT07691892

Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw

Sponsor: Hospital of Stomatology, Wuhan University

View on ClinicalTrials.gov

Summary

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.

Official title: Development and Validation of a Multimodal Risk Prediction Model for Medication-Related Osteonecrosis of the Jaw: A Prospective Cohort Study.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

310

Start Date

2026-08-01

Completion Date

2030-09-01

Last Updated

2026-07-09

Healthy Volunteers

No