Therapeutic Exposures and Risk Factors in MRONJ
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Medication-Related Osteonecrosis of Jaw. Basic parameters: 18 years — 110 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Identification of Therapeutic Exposures and Risk Factors Associated With Medication-Related Osteonecrosis of the Jaw
Overview
This study focuses on patients who have developed a condition called medication-related osteonecrosis of the jaw (MRONJ), which can occur after using certain medications. The purpose is to closely monitor these patients over time to better understand how they are diagnosed, treated, and followed up. By doing this, researchers hope to uncover how different factors such as a patient's background, lifestyle, and other health conditions might influence their recovery and overall quality of life.
Primary outcome measures
- Change in Karnofsky Performance Status [Time frame: 24 months]
- Change in Oral Health-related Quality of Life [Time frame: 24 months]
- Change in staging of MRONJ [Time frame: 24 months]
- Biochemical Markers Related to Bone Metabolism and Inflammatory Response [Time frame: Baseline]
- Change in the Assessment of Radiographic Changes Using the Composite Radiographic Index [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Individuals aged 18 and over
- Male or female individuals
- Individuals who apply to the Marmara University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery due to medication-related osteonecrosis of jaw during the study period
- Individuals or their legal representatives who have given written consent to participate in the study
Exclusion criteria
- Non-drug-related osteonecrosis/osteomyelitis
- Osteoradionecrosis
- Metastasis to the oral region
- Individuals who have not given written consent to participate in the study
- Individuals under the age of 18
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Turkey (Türkiye) · 1 center
- Marmara University School of Dentistry — Istanbul
Publications
- Ruggiero SL, Dodson TB, Aghaloo T, Carlson ER, Ward BB, Kademani D. American Association of Oral and Maxillofacial Surgeons' Position Paper on Medication-Related Osteonecrosis of the Jaws-2022 Update. J Oral Maxillofac Surg. 2022 May;80(5):920-943. doi: 10.1016/j.joms.2022.02.008. Epub 2022 Feb 21. PMID 35300956
- Friendlander AH, Ettinger RL. Karnofsky performance status scale. Spec Care Dentist. 2009 Jul-Aug;29(4):147-8. doi: 10.1111/j.1754-4505.2009.00088.x. No abstract available. PMID 19573040
- Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x. PMID 9332805
Identifiers
NCT: NCT06430762 · CIBON-MAR-A.1