Identification of Therapeutic Exposures and Risk Factors Associated With Medication-Related Osteonecrosis of the Jaw
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Medication-Related Osteonecrosis of Jaw
- Sponsor
- Marmara University
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Change in Karnofsky Performance Status
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Ferit Bayram
Principal Investigator
Marmara University
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
Outcomes
Primary Outcomes
Change in Karnofsky Performance Status
Time Frame: 24 months
This outcome measures the overall health status and activity levels of patients with MRONJ using the Karnofsky Performance Scale (KPS). KPS rates patients on a scale from 0 to 100, where higher scores indicate greater independence and lower morbidity risk, while lower scores reflect dependency and the need for substantial medical intervention. The scale's aim is to quantify the extent to which patients can perform everyday life activities without assistance. At baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3), 18 and 24 months (T4, if required), the questionnaire will be taken.
Change in Oral Health-related Quality of Life
Time Frame: 24 months
A scale of 1 to 5 will be used to rate each of the 14 questions about how dental health affects quality of life (minimum score of 0, maximum score of 70). Higher ratings reflect a greater influence of the patient's dental health on their quality of life (higher scores, worse outcomes). At baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3), 18 and 24 months (T4, if required), the questionnaire will be taken.
Change in staging of MRONJ
Time Frame: 24 months
Staging of the lesion in the mouth will be according to the definition of the American Association of Oral and Maxillofacial Surgeons (Ruggiero et al. 2022). Clinical examination will be performed at baseline (T0), 3 months (T1), 6 months (T2), 12 months (T3), 18 and 24 months (T4, if necessary).
Biochemical Markers Related to Bone Metabolism and Inflammatory Response
Time Frame: Baseline
Various biochemical markers indicative of bone metabolism and inflammatory response in patients with medication-related osteonecrosis of the jaw (MRONJ) will be evaluated. The markers include serum calcium, ionized calcium, parathyroid hormone (PTH), alkaline phosphatase, osteocalcin, C-telopeptide (CTX), Vitamin D3, C-reactive protein (CRP), and leukocyte count. Blood samples collected at baseline will be analyzed.
Change in the Assessment of Radiographic Changes Using the Composite Radiographic Index
Time Frame: 24 months
This outcome involves utilizing the Composite Radiographic Index to track and characterize the progression of lesions in patients with medication-related osteonecrosis of the jaw. This index evaluates: * Location of the lesion: Maxilla anterior, Maxilla posterior, Mandible anterior, Mandibular posterior. * Lyric changes: Scored as 0 (None), 1 (Localized), 2 (Widespread). * Sclerosis: Scored as 0 (None), 1 (Localized), 2 (Widespread). * Periosteal bone formation: Scored as 0 (None), 1 (Localized), 2 (Widespread). * Sequestration: Scored as 0 (None), 1 (Localized), 2 (Widespread). Radiographs will be taken at the initial visit to establish a baseline for each patient. Subsequent radiographs will be taken only if clinically indicated to monitor the presence and progression of osteonecrotic lesions.