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临床试验/NCT04127474
NCT04127474Unknown不适用

Expression of Trefoil Factors 2 and 3 and Adrenomedullin in Unstimulated Saliva Samples of Chronic Periodontitis Subjects With and Without Coronary Heart Disease

Meenakshi Ammal Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年10月14日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
75
试验地点
1
主要终点
Trefoil factors 2 and 3 and Adrenomedullin expression in Chronic periodontitis patients with and without coronary heart disease

研究概览

简要总结

To assess the demographic variables, periodontal parameters and to determine the expression of Trefoil factors 2 and 3 and Adrenomedullin in unstimulated saliva samples of periodontally healthy subjects with coronary heart disease and generalised chronic periodontitis subjects with and without coronary heart disease.

详细描述

A total of 75 subjects will be recruited for the study based on the power of the study.

The selected subjects will be divided into 3 groups based on inclusion and exclusion criteria.

GROUP I:25Generalized chronic periodontitis subjects without coronary heart disease.

GROUP II: 25Generalized chronic periodontitis subjects diagnosed with coronary heart disease.

GROUP III: 25Periodontally healthy subjects diagnosed with coronary heart disease.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients willing to participate in the study.
  • Patients within the age group of 30-65 years.
  • Patients should have ≥ 20 remaining natural teeth.
  • For Group I
  • Systemically healthy, Generalized chronic periodontitis subjects with 30% or more sites with clinical attachment loss (CAL) ≥ 2mm, radiographic evidence of alveolar crestal bone loss ≥ 2mm from the cemento-enamel junction.
  • For Group II
  • Generalized chronic periodontitis subjects with 30% or more sites with clinical attachment loss (CAL) ≥ 2mm, radiographic evidence of alveolar crestal bone loss ≥ 2mm from the cemento-enamel junction along with coronary heart disease.
  • For Group III • Periodontally healthy subjects with Probing pocket depth (PD) less than 4mm, bleeding on probing (BOP) at ≤15% of tooth sites, no periodontal treatment (Scaling and root planing or periodontal surgery) within the previous 6 months and without evident clinical signs of gingival inflammation along with the presence of coronary heart disease.

排除标准

  • Subjects with systemic conditions such as type I and type II diabetes mellitus, respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies and HIV infection will be excluded from the present investigation.
  • For Group I, subjects on drugs such as corticosteroids, antibiotics, within 6 months of investigation will be excluded.
  • Current smokers and individuals who quit smoking less than 6 months.
  • Patients who have undergone periodontal therapy within the previous 6 months.
  • Pregnant women (pregnancy may alter the oral flora)

结局指标

主要结局

Trefoil factors 2 and 3 and Adrenomedullin expression in Chronic periodontitis patients with and without coronary heart disease

时间窗: 12 months

Expression of Trefoil factors 2 and 3 and Adrenomedullin using Enzyme Linked Immunosorbent Assay

次要结局

未报告次要终点

研究者

发起方
Meenakshi Ammal Dental College and Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr.Jaideep Mahendra

Professor, PhD guide, Director of Post Graduate Studies

Meenakshi Ammal Dental College and Hospital

研究点 (1)

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