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临床试验/CTRI/2018/11/016360
CTRI/2018/11/016360招募中不适用

Comparative evaluation of Gingival Crevicular Fluid haem and microbial composition in smokers and non-smokers with chronic localized periodontitis- A Clinicomicrobiologial study.

Rajiv Gandhi University of Health Sciences Karnataka1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2018年7月5日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
74
试验地点
1
主要终点
Initiation and progression of periodontal diseases is the result of a complex interaction between the bacteria colonizing the gingival crevice and the innate and inflammatory responses of the host.this study aims to closely investigate the relationship between GCF free haem concentration, subgingival microbial composition and periodontal clinical parameters in smokers and non-smokers and find out if GCF free haem could be used as a biomarker for periodontal diseases.

研究概览

简要总结

study aims to investigate the level of local free haem in GCF at periodontally healthy sites compared with diseased sites in relation to clinical parameters and also to determine any correlation between smoking and haem concentrations at healthy and diseased sites. From a total of 74 subjects  GCF and subgingival plaque samples  will be collected from healthy and diseased sites in both smokers and non-smokers.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Systemically healthy individuals aged between 20-50 years
  • Subjects with at least 20 teeth and 2 non-adjacent probing pocket depth ≥ 5mm and CAL ≥ 3mm per quadrant with radiographic bone loss >20%.

排除标准

  • Medically compromised patients or any systemic illness which can influence the haemoglobin level of the subject.
  • Pregnant/lactating women
  • Subjects who have taken antibiotics before the initiation of study
  • Subjects with a history of periodontal treatment in the last 6 months
  • Subjects with symptoms of acute illness, orthodontic appliances or presence of oral mucosal inflammatory conditions or salivary gland dysfunction.

结局指标

主要结局

Initiation and progression of periodontal diseases is the result of a complex interaction between the bacteria colonizing the gingival crevice and the innate and inflammatory responses of the host.this study aims to closely investigate the relationship between GCF free haem concentration, subgingival microbial composition and periodontal clinical parameters in smokers and non-smokers and find out if GCF free haem could be used as a biomarker for periodontal diseases.

时间窗: 3 months

次要结局

  • This will help us in identifying susceptible patients in large populations very easily and quickly as it is a chair side diagnostic test. It will also help us to identify active diseased sites, predict sites vulnerable for future breakdown and serve as surrogate end points for monitoring the effectiveness of therapy which may not be possible with conventional diagnostic aids(2 points)

研究者

发起方
Rajiv Gandhi University of Health Sciences Karnataka
申办方类型
Government funding agency

研究点 (1)

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