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临床试验/NCT02775266
NCT02775266已完成不适用

Effect of Systemic Administration of ALA (Alpha Lipoic Acid) as an Adjunct to Scaling and Rootplaning on Serum Resistin Levels in Patients With Chronic Periodontitis and Type 2 Diabetes Mellitus

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Serum Resistin Levels and HBAIC Levels

研究概览

简要总结

To evaluate the effectiveness of non surgical periodontal therapy in addition to antioxidant(ALA) on resistin levels in patients with type 2 diabetes and periodontal disease

详细描述

A total of 40 patients with diabetes and chronic periodontitis attending the department of periodontics will be recruited in the study. 40 subjects will be randomly divided into two groups(control group and test group with 20 subjects in each group). Clinical parameters such as gingival index, periodontal index, random blood sugar levels(RBS) and glycosylated hemoglobin levels (Hb1aC) will be recorded at baseline and after 3 months and 2ml of blood sample will be collected by venepuncture ( baseline and after 3 months) and stored in Ethylenediaminetetraacetic acid containing vials to identify the levels of resistin in the patients by Enzyme linked immunosorbent assay. Group A will receive Alpha lipoic acid at baseline for a period of 3 months. Both the groups will receive scaling and rootplaning at baseline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diabetic patients with Chronic periodontitis.

排除标准

  • Smokers, Pregnant & lactating women, Prior periodontal therapy within 3 months.

结局指标

主要结局

Serum Resistin Levels and HBAIC Levels

时间窗: 3 months

2ml of blood sample will be collected by venepuncture at baseline and after 3 months and will be assessed by ELISA stored in EDTA containing vials to identify the levels of resistin in the patients by ELISA. Glycosylated hemoglobin levels (Hb1aC) will be recorded at baseline and after 3 months and assessed by Spectrophotometer.

次要结局

  • Clinical Attachment levels(3 Months)
  • Probing pocket depth(3 months)
  • Gingival Index(3 months)

研究者

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

kinnera surapaneni

PG student

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

研究点 (2)

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