Immunological Parameters Between MRONJ Stages

Recruiting

• Conditions: Medication-Related Osteonecrosis of Jaw

• Registration Number: NCT06420284
• Lead Sponsor: Marmara University

Brief Summary

This study aims to conduct a detailed analysis of the immunological response profiles that emerge at different clinical stages of medication-related osteonecrosis of the jaw (MRONJ). The research seeks to understand how these responses influence the pathogenesis, staging, and treatment of MRONJ. Throughout the study, cytokine levels, inflammation markers, and other immunological parameters observed at various stages will be comprehensively assessed. The results of these analyses are expected to provide insights into how stage-specific immunological variables could play a role in the diagnosis and treatment of MRONJ.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-01
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Last Update Submitted: 2024-05-14
• Study First Posted: 2024-05-20
• Last Update Posted: 2024-05-20
• Primary Completion: 2025-02-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Individuals aged 18 and over
• Both male and female participants
• Individuals who apply to the Oral and Maxillofacial Surgery Clinic at Marmara University Faculty of Dentistry due to medication-related osteonecrosis of the jaw during the study period
• Individuals or their legal representatives who have provided 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apoptosis Analysis in Lymphocytes	Baseline	This outcome assesses apoptosis in lymphocytes isolated from the peripheral blood of participants included in the study. This analysis aims to quantify apoptotic processes in lymphocytes, offering insights into cell death mechanisms under varying conditions of culture and potentially relating these mechanisms to the immunopathology of MRONJ.
Lymphocyte Proliferation Analysis	Baseline	This outcome evaluates the proliferation capacity of peripheral blood mononuclear cells (PBMCs) isolated from the study participants. This analysis will help quantify and understand the dynamics of lymphocyte activation and proliferation in response to different clinical stages of MRONJ and potentially identify immunological differences that could inform therapeutic strategies.
Cytokine Profile Analysis	Baseline	This outcome measures the levels of specific cytokines as indicators of immunological response in MRONJ at different disease stages. The cytokines to be analyzed include IL-17, IL-2, IL-4, IL-6, IL-10, TNF-α, and IFN-γ.

Trial Locations

Locations (1)

Marmara University School of Dentistry; 🇹🇷 Istanbul, Turkey