Therapeutic Exposures and Risk Factors in MRONJ

Recruiting

• Conditions: Medication-Related Osteonecrosis of Jaw

• Registration Number: NCT06430762
• Lead Sponsor: Marmara University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-25
• Status Verified: 2024-05
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28
• Primary Completion: 2026-04-25
• Study Completion: 2027-04-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Karnofsky Performance Status	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	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	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	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	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.

Trial Locations

Locations (1)

Marmara University School of Dentistry; 🇹🇷 Istanbul, Turkey