Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the Jaw
2. července 2026 aktualizováno: Lingxin Zhu, Hospital of Stomatology, Wuhan University
Development and Validation of a Multimodal Risk Prediction Model for Medication-Related Osteonecrosis of the Jaw: A Prospective Cohort Study.
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.
Přehled studie
Postavení
Zatím nenabíráme
Typ studie
Pozorovací
Zápis (Odhadovaný)
310
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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.
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
MRONJ risk cohort
Participants at risk of medication-related osteonecrosis of the jaw will be prospectively enrolled and followed to evaluate multimodal predictors for early warning and risk prediction of MRONJ.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of medication-related osteonecrosis of the jaw within 12 months after the invasive oral procedure.
Časové okno: 12 months after the invasive oral procedure.
|
The occurrence of medication-related osteonecrosis of the jaw will be assessed according to the diagnostic criteria of the American Association of Oral and Maxillofacial Surgeons.
Clinical examination and cone-beam computed tomography will be used to determine whether participants develop medication-related osteonecrosis of the jaw during follow-up.
|
12 months after the invasive oral procedure.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Area under the receiver operating characteristic curve of the multimodal prediction model for medication-related osteonecrosis of the jaw.
Časové okno: 3 months, 6 months, 12 months after the invasive oral procedure.
|
The area under the receiver operating characteristic curve (AUC) will be used to evaluate the discrimination performance of a multimodal early warning and risk prediction model for medication-related osteonecrosis of the jaw.
The model will integrate clinical characteristics, medication exposure, oral examination findings, cone-beam computed tomography imaging features, and proteomic and metabolomic biomarkers from body fluid samples.
|
3 months, 6 months, 12 months after the invasive oral procedure.
|
|
Sensitivity and specificity of the multimodal prediction model for medication-related osteonecrosis of the jaw.
Časové okno: 3 months, 6 months, 12 months after the invasive oral procedure.
|
Sensitivity and specificity will be calculated as the proportion of participants who do not develop medication-related osteonecrosis of the jaw and are correctly classified as low risk by the multimodal prediction model.
|
3 months, 6 months, 12 months after the invasive oral procedure.
|
|
Early clinical manifestations and progression patterns of medication-related osteonecrosis of the jaw.
Časové okno: 1 week, 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after the invasive oral procedure.
|
Early clinical manifestations and progression patterns will be assessed based on wound healing, pain, swelling, suppuration, numbness, bone exposure, fistula formation, and cone-beam computed tomography findings during follow-up.
|
1 week, 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after the invasive oral procedure.
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. srpna 2026
Primární dokončení (Odhadovaný)
1. září 2029
Dokončení studie (Odhadovaný)
1. září 2030
Termíny zápisu do studia
První předloženo
2. července 2026
První předloženo, které splnilo kritéria kontroly kvality
2. července 2026
První zveřejněno (Aktuální)
9. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
9. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
2. července 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- WDKQ2026B51
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