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临床试验/NCT03775967
NCT03775967已完成不适用

Estimation of Sialic Acid and IL10 Levels in Stage 1 and 2 Periodontitis Patients

Ajman University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Sialic acid levels in stage 2 periodontitis

研究概览

简要总结

Sialic acid (SA) is the generic term given to a family of acetylated derivatives of neuraminic acid. SA is a 9 carbon monosaccharide. An important function of host SA is to regulate innate immunity. SA is present in several acute phase proteins which are known to be associated with periodontitis. There exists a need for a biomarker, for early detection of disease evolution and more robust therapy efficacy measurements. Till date, there is very little data regarding simultaneous estimation and comparison of total SA content in saliva. IL-10, an anti-inflammatory cytokine, regulates the synthesis of pro-inflammatory cytokines such as IL-1, -2, -6 and stimulates protective antibody production. IL-10 is expressed in both healthy and diseased human periodontal tissues and is reported to be reduced in patients infected with Aggregatibacter actinomycetemcomitans.

The present study was therefore undertaken with an aim, to not only assess the levels of TSA(Total sialic acid levels),but also of IL 10 levels in saliva from stage 1(mild) to stage 2(moderate) periodontitis patients

详细描述

Selection of patients by grading the patients according to criteria stage 1 and 2 Periodontitis

Obtaining consent from patients participating in the study

Collection of saliva-unstimulated whole saliva, the samples will be stored at -20 degree Centigrade and later placed in a 1.5ml centrifuge tubes which will be placed in a vacuum cool box indicated for laboratory samples and transported to the lab for investigations. It will be centrifuged at 2500 rpm for 10 mins,stored at -80 deg C. SA(sialic acid) levels will be determined by thiobarbutic acid method of aminoff and ELISA methods. SA levels will be measured in mg/dl,IL10 as in direct measurement.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All the subjects should be within the age group of 18 to 55 years
  • subject should have atleast 18 natural teeth excluding third molars.

排除标准

  • History of periodontal debridement or periodontal surgery in preceding six months or any antimicrobial therapy, anti-inflammatory drugs.
  • corticosteroids, in previous three months
  • systemically compromised individuals
  • pregnant and lactating women
  • Medical history for absence of systemic disorders such as diabetes mellitus
  • cardiovascular diseases
  • pneumonia
  • tuberculosis
  • rheumatoid arthritis

结局指标

主要结局

Sialic acid levels in stage 2 periodontitis

时间窗: From baseline to 3 months

Sialic acid is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients

IL10 levels in stage 2 periodontitis

时间窗: From baseline to 3 months

IL10 is measured by taking salivary samples(unstimulated) from stage 2 periodontitis patients

IL10 levels in stage 1 periodontitis

时间窗: From baseline to 3 months

IL10 is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients

Sialic acid levels in stage 1 periodontitis

时间窗: From baseline to 3 months

Sialic acid is measured by taking salivary samples(unstimulated) from stage 1 periodontitis patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

sudhir rama varma

Assistant Professor

Ajman University

研究点 (1)

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