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临床试验/CTRI/2025/04/084440
CTRI/2025/04/084440尚未招募不适用

Estimation of galectin-3 and tumor necrosis factor a levels in gingival crevicular fluid of periodontitis patients with and without obesity - An observational study

Dr Divya Shonima1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年4月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
Galectin 3 and TNF alpha level in GCF

研究概览

简要总结

This study is an observational study assesing the levels of Galectin-3 and Tumor necrosis factor alpha in GCF of periodontitis patients with and without obesity . It will be conducted in The Oxford Dental College , Bangalore in India . The primary outcome measure will be Galectin-3 and TNF alpha levels in GCF . The secondary outcome measure will be clinical parameters - Gingival index, bleeding on probing, probing depth and clinical attachment loss . 36 GCF sample is taken from 12 subjects in each group and biomarker levels  will be assessed using ELISA method .

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Subjects of either sex, between the age of 20 and 60 years 2) Presence of at least 20 natural teeth 3) Individuals with healthy periodontium of clinical parameters of bleeding on probing less than 10 % and probing depth less than or equal to 3 mm 4) Patients with diagnosis of generalised stage III grade B periodontitis with clinical parameters of probing depth more than or equal to 6 mm and clinical attachment loss more than or equal to 5 mm 5) Subjects with obesity having BMI values given by Asia Pacific Perspective Obesity.
  • WHO 2000 Non obese.
  • between range of 18.5 to 22.9 kg/m2 Obese.
  • between range of 25 to 29.9 kg/m2.

排除标准

  • Individuals with systemic diseases 2) Smokers 3) Pregnant/lactating and postmenopausal women 4) Individuals who have received periodontal therapy in the last 6 months 5) Individuals who have history of antimicrobial and anti-inflammatory therapy in the past 6 months.

结局指标

主要结局

Galectin 3 and TNF alpha level in GCF

时间窗: baseline

次要结局

  • Clinical parameters - Gingival index, Bleeding on probing, Probing depth, Clinical attachment loss(baseline)

研究者

发起方
Dr Divya Shonima
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Divya Shonima

The Oxford Dental College, Bangalore

研究点 (1)

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