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临床试验/NCT04180332
NCT04180332已完成不适用

Anti Oxidant Enzymes and Total Antioxidant Levels in Diabetes Mellitus Type II Patients and Healthy Individuals With Periodontitis

Ajman University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年8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
300
试验地点
1
主要终点
Catalase estimation

研究概览

简要总结

To evaluate the role of antioxidants - superoxide dismutase, catalase, glutathione and total anti oxidant levels in the serum of chronic periodontitis patients and chronic periodontitis with DM Type II patients, then to compare it with healthy controls, to assess their possible role as biomarkers for chronic periodontitis and the possible systemic effects of periodontitis.

详细描述

This was a cross sectional study involving 300 subjects ,30-60 years of age. 80% was calculated as the power of the study and error was set at 5%. The ethical clearance for the study was obtained from the University central ethics committee. A consent form, was given to all the subjects, which was explained to them and a written consent was taken before enrolling them. As per the prepared case history format, case history was taken for all the subjects who were part of the study The body mass index (BMI) was assessed and subjects who were overweight & obese, with a BMI above 25 , were not included in the study.7 Of the total of 300 subjects,100 subjects who did not have any systemic diseases were included in group I and III, and 100 subjects with diabetes mellitus type II, who were not suffering from any other systemic diseases were included in group II. The diabetic patients in group II were on oral medication (Metformin derivatives) and appropriate diet control measures, for a period of at least one year but not more than five years.

Group I and II patients had chronic generalized severe periodontitis.8 Subjects in group III were systemically healthy and not suffering from any periodontal disease. A single trained investigator examined the periodontal status of all the subjects. Any other type of periodontitis was not included in the study.

Subjects were excluded if they had taken antibiotics any time in the last 4 weeks. Vitamin and mineral supplement intake and those who underwent periodontal treatment procedures in the course of the last 6 months were eliminated from the study. Tobacco users, alcoholics, pregnant as well as lactating women were not included in the study.

Only subjects who had a a RBS score of less than 120 and HbA1c score of less than 7 were accepted in the study.

Then a periodontal examination was carried out, the status of the periodontal condition was determined, and the subjects were alloted to the three groups by the single trained investigator,patient was also referred to a physician to determine the systemic condition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

盲法说明

None were masked

入排标准

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

入选标准

  • 100 subjects with chronic periodontitis who did not have any systemic diseases were included in group I
  • 100 subjects with chronic periodontitis and diabetes mellitus type II, who were not suffering from any other systemic diseases were included in group II, The diabetic patients in group II were on oral medication (Metformin derivatives) and appropriate diet control measures, for a period of at least one year but not more than five years.
  • 100 subjects systemically healthy and not having any periodontal disease were included in group III.

排除标准

  • Subjects were excluded if they had taken antibiotics any time in the last 4 weeks, or taken vitamin and mineral supplements or underwent periodontal treatment procedures in the course of the last 6 months.
  • Tobacco users, alcoholics, pregnant as well as lactating women were also excluded from the study.

结局指标

主要结局

Catalase estimation

时间窗: From baseline to 5 months

The estimation will be carried out using ELISA biochemical assay

次要结局

  • Antioxidant estimation(From baseline to 5 months)

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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