New model aims to predict jaw bone disease before it strikes

NCT ID NCT07691892

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First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study is developing a way to predict who might develop a serious jaw bone condition called medication-related osteonecrosis of the jaw (MRONJ) after dental procedures. Researchers are following adults who have taken bone-strengthening drugs like bisphosphonates or denosumab for at least two years and are scheduled for invasive dental work. By combining clinical exams, imaging, and biological samples like saliva and blood, they hope to build a risk prediction model that could help prevent this painful complication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a tool that helps dentists and doctors identify patients at high risk of jaw bone damage before oral procedures, allowing for better preventive care.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve outcomes. The prediction model may not be accurate enough for widespread use.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 310 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults aged 18 to 70 years, regardless of sex. 2. Currently receiving bone-modifying agents, including bisphosphonates or denosumab, for osteoporosis or bone metastases. 3. Continuous use of bone-modifying agents for at least 24 months before enrollment. 4. 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. 5. 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. 6. Able to understand the study purpose and procedures and willing to provide written informed consent. Exclusion Criteria: 1. Previously diagnosed or suspected medication-related osteonecrosis of the jaw. 2. Other diseases or conditions that may cause osteonecrosis of the jaw, such as osteoradionecrosis or malignant tumors of the jaw. 3. Severe coagulation disorders or active bleeding disorders that preclude invasive oral procedures. 4. 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. 5. Autoimmune disease or current immunosuppressive therapy that may affect bone metabolism or immune status assessment. 6. Salivary gland dysfunction, such as Sjögren's syndrome, that may affect the quality of saliva sample collection. 7. Pregnancy or breastfeeding. 8. Psychiatric disorders or cognitive impairment that would prevent understanding of the study procedures or compliance with follow-up. 9. Uncontrolled hypertension or diabetes mellitus, or a history of stroke or transient ischemic attack within the past 6 months. 10. Use of any vaccine for the prevention of infectious diseases, such as influenza or varicella vaccine, within 4 weeks before enrollment. 11. 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. 12. Participation in another clinical study that may interfere with the results of this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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