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临床试验/NCT06755372
NCT06755372招募中不适用

The Role of Toll-like Receptor-4 in Periodontitis Patients With End-stage Renal Disease in a Sample of Egyptian Population

Ain Shams University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年4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
100
试验地点
1
主要终点
Clinical Attachment Level (CAL):

研究概览

简要总结

Chronic kidney disease (CKD) is a significant public health issue in Egypt, leading to end-stage renal disease (ESRD). ESRD patients often suffer from oral abnormalities due to the disease and medications. Periodontitis is linked to systemic diseases, including renal disease, with inflammation playing a key role. TLR4 genetic variations may influence susceptibility to CKD and periodontitis. This study investigates the association between TLR4 [Gly/Thr (rs2149356)] polymorphism and chronic periodontal disease in ESRD patients in Egypt.

详细描述

Chronic kidney disease (CKD), which ranks sixth among the top causes of death from 2009 to 2019, has become 36% more prevalent in Egypt, following the global trend (The Center for Economic and Social Rights: 2021).

Since untreated CKD can lead to end-stage renal disease (ESRD), which is the complete loss of renal function when patients are dialysis-dependent and require a kidney transplant, CKD has emerged as a significant public health issue in Egypt (Chen et al., 2024).

According to the most recent data available, the prevalence of dialysis in Egypt was 0.61 per 1000 persons in 2019; the incidence was estimated to be 0.19 per 1000 people (Bello et al., 2029; Farag et al., 2022).

ESRD patients exhibit a variety of oral abnormalities, as the disease and the medications taken by those patients might exacerbate or cause the development of caries, periodontal disease, mucosal lesions, decreased saliva production, and other oral disorders (Trzcionka et al., 2020).

Periodontitis is a widely prevalent inflammatory and infectious disease affecting the supporting structure of the teeth. In the past few decades, the association between periodontitis and systemic diseases has received much attention (Abou-Bakr et al., 2022; Mainas et al., 2022).

研究设计

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

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age: 30 to 60 years
  • •Gender: Both male and female
  • •Diagnosed with Periodontitis stage II and/or stage III
  • •Systemically healthy, no history of systemic diseases
  • •Not on long-term medications

排除标准

  • •Individuals with any systemic disease or long-term medication use
  • •Group II: ESRD Patients with Periodontitis
  • •Inclusion Criteria:
  • •Age: 30 to 60 years
  • •Gender: Both male and female
  • •Diagnosed with end-stage renal disease (ESRD) on regular hemodialysis
  • •Diagnosed with Periodontitis stage II and/or stage III
  • •Unrelated Egyptians from a similar socioeconomic status, residing in the same geographical area
  • •Underlying type 2 diabetes mellitus
  • •Exclusion Criteria:
  • •Individuals with kidney transplants
  • •Individuals with systemic diseases other than diabetes
  • •History of malignancy

结局指标

主要结局

Clinical Attachment Level (CAL):

时间窗: single point "Baseline"

Description: The CAL measures the extent of periodontal support around a tooth, from the cementoenamel junction (CEJ) to the base of the pocket, crucial for diagnosing periodontal disease. Measurement Method: CAL is recorded using a periodontal probe by measuring probing depth (PD) and distance from the gingival margin to the CEJ. CAL is calculated as follows: CEJ at gingival margin: CAL = PD Gingival margin coronal to CEJ: CAL = PD - Distance from Gingival Margin to CEJ Gingival margin apical to CEJ: CAL = PD + Distance from CEJ to Gingival Margin in non- periodontitis individuals CAL is zero

次要结局

  • Bleeding on Probing (BOP)(single point "Baseline")

研究者

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

Fatma ElSayed

assistant professor

Ain Shams University

研究点 (1)

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