跳至主要内容
临床试验/CTRI/2024/04/065686
CTRI/2024/04/065686已完成不适用

Determination of insulin sensitivity and its correlation to Periodontal Inflamed Surface Area (PISA) and Tumor Necrosis Factor-α (TNF-α) in patients with Periodontitis.

Dr Menaka K B1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月20日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
1. Homeostasis model assessment of insulin resistance (HOMA-IR)

研究概览

简要总结

This will be a Observational cross-sectional study conducted in the department of periodontics KLE VKIDS which will enroll a total of 60 patients into 2 groups. Periodontitis will be assessed using PISA and insulin sensitivity will be checked with HOMA-IR index. PISA quantifies the surface of bleeding pocket epithelium and estimates the inflammatory burden as periodontitis causes systemic inflammatory burden through release of inflammatory mediators. the bi-directional link between periodontitis and Diabetes Mellitus is well established, however, studies assessing the link of periodontitis to insulin sensitivity are limited. TNF-alpha is linked to the pathogenesis of  Insulin sensitivity and is one of the inflammatory mediators released during periodontitis. Therefore, the present study intends to determine the insulin sensitivity in patients with periodontitis and correlate salivary levels of TNF-alpha.

研究设计

研究类型
Observational

入排标准

年龄范围
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Patients with healthy periodontium
  • Patients diagnosed with periodontitis
  • Patients with no history of any kind of systemic diseases.

排除标准

  • No previous periodontal treatment.
  • Patients with history of smoking and tobacco chewing
  • Pregnant or lactating women.
  • Patients diagnosed with bleeding disorders.
  • Patients on any kind of medications.

结局指标

主要结局

1. Homeostasis model assessment of insulin resistance (HOMA-IR)

时间窗: Baseline - Sample analyzed at a single point in time

2. Periodontal Inflamed Surface Area (PISA)

时间窗: Baseline - Sample analyzed at a single point in time

次要结局

  • Salivary levels of Tumor Necrosis Factor-α (TNF-α)(Baseline - sample analyzed at one point in time)

研究者

发起方
Dr Menaka K B
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Menaka KB

KAHER KLE VK Institute of Dental Sciences.

研究点 (1)

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