None listed
Conditions
Interventions
None listed
Sponsors
Ewha Womans University Seoul Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A. Those aged 19 years or older and whose jaw bone has fully grown B. Those who have signed the informed consent form and the human-derived material consent form C. Those who have received or are currently receiving medications that may induce osteonecrosis of the jaw due to osteoporosis: Those receiving related medications such as IV bisphosphonates, denosumab, angiogenesis inhibitors, and romosozumab, and those receiving oral osteoporosis medications
Exclusion criteria
Exclusion criteria: A. Those who have received radiation therapy to the head and neck area, including the jaw, or have been diagnosed with a malignant tumor in the jaw area. B. Those who the investigator determines are inappropriate for participation in the clinical trial for ethical reasons or because it may affect the results of the clinical trial. C. Those who do not understand the purpose of the study and do not consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biomarker levels and predictive performance indicators: Differences in quantitative expression levels of multi-omics (proteomic, genomic, etc.) biomarkers in blood and saliva between MRONJ cases and controls.;Diagnostic accuracy indicators: Area under the receiver operating characteristic (ROC) curve (AUC), sensitivity, specificity, positive/negative predictive value (PPV/NPV), and accuracy to verify the biomarker's ability to predict the occurrence of MRONJ.;Prognostic predictors: Changes in biomarker levels over time and the significance of the interaction effect between group and time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical risk factors: Demographic variables (age, sex, BMI, etc.) and clinical factors (type of osteoporosis medication, duration of administration, invasive dental treatment, underlying disease, etc.) that may affect the occurrence of MRONJ.;Clinical features of MRONJ lesions: location, size, stage, pain intensity (VAS), degree of exposure and swelling, presence of sensory abnormalities, presence of fistulas, etc. at the time of MRONJ onset. | — |
Countries
Korea, Republic of
Contacts
Public Contacthyun hwang
Ewha Womans University Medical Center
Outcome results
None listed