跳至主要内容
临床试验/NCT06420284
NCT06420284招募中不适用

Characterization of Immunological Parameters in Different Clinical Stages of Medication-Related Osteonecrosis of the Jaw

Marmara University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
42
试验地点
1
主要终点
Apoptosis Analysis in Lymphocytes

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Non-drug-related osteonecrosis/osteomyelitis
  • Osteoradionecrosis
  • Metastasis to the oral region
  • Individuals who have not given written consent to participate in the study

结局指标

主要结局

Apoptosis Analysis in Lymphocytes

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ferit Bayram

Assist. Prof.

Marmara University

研究点 (1)

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