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临床试验/NCT06400069
NCT06400069已完成不适用

Evaluation of Serum NLRP6 in Chronic Periodontitis Patients

Babol University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年12月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Quantification of NLRP6 gen, Quantification of NLRP6 gen using RT-PCR

研究概览

简要总结

The quantification of NLRP6 in blood samples will be analyzed from individuals with chronic periodontitis but without systemic disease. Demographic and periodontal parameters will be assessed and correlated with the NLRP6 quantification using RT-PCR.

详细描述

This study aims to collect demographic variables, including age, education level, BMI, personal habits, medication use, and history of systemic disease, from non-smoking individuals with chronic periodontitis. Initially, we will determine the expression level of the NLRP6 gene in blood samples taken from chronic periodontitis subjects who are matched for age and sex. Subsequently, we will investigate the relationship between gene expression levels, taking into account the confounding effect of body mass index, and explore how these levels correlate with the severity of the disease.

In this study, two groups: chronic periodontitis (CP) and healthy controls (HC) will be examined. The CP group will consist of patients diagnosed with Stage I to IV periodontitis based on the consensus report from the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. Additionally, we will include systemically healthy individuals. Serum samples will be collected from all patients, and the Plaque Index (PI) and Gingival Index (GI) will be recorded at four sites per tooth. Furthermore, we will assess full-mouth probing depth (PD) and clinical attachment level (CAL) at six sites per tooth. The percentage of bleeding areas will be documented as the proportion of sites with bleeding on probing (BOP) within 20 seconds after probing.

For blood sampling, a total of 3 mL of blood will be collected from the antecubital vein of each individual by an expert nurse from the Department of Periodontology.

Statistical analysis will be conducted using statistical software for data science (Stata version 17). A significance value (p-value) of less than 0.05 will be considered statistically significant. The sample size for the study was determined using the power paired means module in Stata 17. We planned to include at least 25 individuals in each group, aiming for a significance level of 5%, statistical power of 80%, and a correlation coefficient of 0.2.

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
25 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: At least 25 years old
  • Clinical diagnosis of chronic periodontitis
  • At least 15 teeth in the mouth

排除标准

  • premalignant lesions and cancer of the oral cavity
  • periodontal treatment in the last 6 months
  • systemic disorders affecting the periodontal condition (autoimmunity and endocrine disorders)
  • diabetes mellitus and rheumatoid arthritis
  • pregnancy or breastfeeding
  • taking drugs with the possibility of affecting the periodontal condition (calcium channel blockers, anticonvulsants, etc.)
  • aggressive PD

结局指标

主要结局

Quantification of NLRP6 gen, Quantification of NLRP6 gen using RT-PCR

时间窗: 12 months

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

Morteza Rabbani

Morteza Rabbani, DS

Babol University of Medical Sciences

研究点 (1)

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