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

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.

Exclusion criteria

• 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.
• Uncontrolled hypertension or diabetes mellitus, or a history of stroke or transient ischemic attack within the past 6 months.
• Use of any vaccine for the prevention of infectious diseases, such as influenza or varicella vaccine, within 4 weeks before enrollment.
• 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.
• Participation in another clinical study that may interfere with the results of this study.