Clinical trial NCT06430762: Therapeutic Exposures and Risk Factors in MRONJ
Official title: Identification of Therapeutic Exposures and Risk Factors Associated With Medication-Related Osteonecrosis of the Jaw
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Medication-Related Osteonecrosis of Jaw
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population for this research comprises individuals aged 18 and over, both male and female, who present with medication-related osteonecrosis of the jaw (MRONJ) at the Oral and Maxillofacial Surgery Clinic of Marmara University Faculty of Dentistry. The study excludes individuals with non-drug-related osteonecrosis or osteomyelitis, osteoradionecrosis, those with metastasis to the oral region, individuals who have not provided consent, and those under the age of 18.

Brief summary: 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.


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

Primary outcomes:
measure: Change in Karnofsky Performance Status
timeFrame: 24 months
measure: Change in Oral Health-related Quality of Life
timeFrame: 24 months
measure: Change in staging of MRONJ
timeFrame: 24 months
measure: Biochemical Markers Related to Bone Metabolism and Inflammatory Response
timeFrame: Baseline
measure: Change in the Assessment of Radiographic Changes Using the Composite Radiographic Index
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Dentistry
Study officials:
affiliation: Marmara University Faculty of Dentistry
name: Ferit Bayram, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.