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临床试验/NCT03727035
NCT03727035Unknown不适用

Quantification of CD163 Inflammatory Biomarker in Subgingival Plaque Samples of Generalized Chronic Periodontitis With or Without Type II Diabetes Mellitus

Meenakshi Ammal Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年2月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Expression of CD163 gene

研究概览

简要总结

The quantification of CD163 will be analysed in the subgingival plaque samples of generalized chronic periodontitis patients with and without diabetes mellitus. The demographic and the periodontal parameters were assessed and the correlated with the quantification of the CD163. The CD163 gene expression was analyzed with RT-PCR and the quantification of CD163 will be done using ELISA.

详细描述

The quantification of CD163 will be analysed in the subgingival plaque samples of generalized chronic periodontitis patients with and without diabetes mellitus. A total of 80 subjects with generalized chronic periodontitis were selected and divided into two groups. Group I comprised of 40 subjects who were diagnosed with generalized chronic periodontitis without any systemic conditions. Group II comprised of 40 generalized chronic periodontitis patients with type II diabetes mellitus. Demographic variables such as age, weight, height, BMI and income and the clinical parameters such as plaque index, bleeding on probing, probing pocket depth and clinical attachment level were recorded. Subgingival plaque samples were collected from both the groups.The collected samples were subjected to further molecular analysis for the CD163 expression using RT-PCR and for the CD163 quantification using ELISA. The elevated levels of CD163 in the subgingival plaque samples of generalized chronic periodontitis subjects with diabetes is expected and the early identification of patients at risk for diabetes mellitus and periodontitis.

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 (both male and female)
  • Patients should have ≥ 10 natural teeth.
  • Criteria for selection of generalized chronic periodontitis:
  • Patients having 30% or more sites with clinical attachment loss(CAL) ≥ 5mm.
  • Criteria for selection of type II diabetes mellitus:
  • Patients having HbA1C <7

排除标准

  • Patients with systemic conditions such as respiratory diseases, renal disease, liver disease, rheumatoid arthritis, allergy, advanced malignancies and HIV infection will be excluded from the present investigation.
  • Patients on drugs such as corticosteroids, antibiotics, aspirin, within 3months of investigation will be excluded.
  • Current smokers, individuals who quit smoking less than 6 months.
  • Patients who had undergone periodontal therapy within the previous 6 months.
  • Pregnant women (which may alter the oral flora).

结局指标

主要结局

Expression of CD163 gene

时间窗: 12 months

Expression of CD163 gene using RT-PCR

次要结局

  • Quantify the levels of CD163(12 months)

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 and PhD guide

Meenakshi Ammal Dental College and Hospital

研究点 (1)

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