Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw (NCT07691892) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw
310 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
. Able to understand the study purpose and procedures and willing to provide written informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of medication-related osteonecrosis of the jaw within 12 months after the invasive oral procedure.
Timeframe: 12 months after the invasive oral procedure.
. 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.
. Autoimmune disease or current immunosuppressive therapy that may affect bone metabolism or immune status assessment.
. Salivary gland dysfunction, such as Sjögren's syndrome, that may affect the quality of saliva sample collection.
. Pregnancy or breastfeeding.
. Psychiatric disorders or cognitive impairment that would prevent understanding of the study procedures or compliance with follow-up.