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临床试验/NCT03620396
NCT03620396已完成不适用

Comparison of Serum Levels of Trefoil Factor 3 in Patients With Gingivitis and Periodontitis Following Non Surgical Periodontal Therapy

Dr.K.Sai Priyanka0 个研究点目标入组 40 人开始时间: 2016年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
主要终点
Trefoil factor 3

研究概览

简要总结

This study is intended to measure serum trefoil factor 3 at baseline and 3 months after, following nonsurgical periodontal therapy in patients with Gingivitis and Chronic Periodontitis.

详细描述

A goal of periodontal diagnostic procedure is to provide useful information to the clinician regarding the present periodontal disease type and severity. Advances in diagnostic research are moving towards methods where periodontal risk can be identified and quantified by objective measures such as Biomarkers.

Trefoil factors (TFFs) are one such secreted molecules derived from mucin producing epithelial cells of the gastro intestinal tracts and other tissues such as Salivary glands, Parotid ducts and oral mucosa. Among three Trefoil factors reported, Trefoil Factor 3 (TFF3) is the modifying factor for signalling pathway involved in cell survival, cell proliferation and cell migration of oral keratinocytes. Hence assessing the marker levels would achieve beneficial effects on diagnosing the disease severity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • For Gingivitis:
  • Gingival Index: 1.1 to
  • Modifies Plaque Index: 1.0 to 1.9
  • For Periodontitis:
  • Gingival Index: 1.1 to
  • Modifies Plaque Index: 1.0 to 1.9
  • Probing depth > 4mm
  • Clinical attachment loss > 2mm

排除标准

  • For Gingivitis:
  • Presence of gingival recession.
  • Presence of clinical attachment loss.
  • Presence of furcation.
  • Presence of systemic infections like diabetes, infections.
  • Antibiotic therapy received preceding 3 months.
  • Patients who underwent periodontal therapy within 3 months.
  • Pregnant and Lactating women.
  • For Periodontitis:
  • Presence of any systemic conditions like diabetes, infections.
  • Antibiotic therapy received preceding 3 months.
  • Patients who underwent periodontal therapy within 3 months.
  • Pregnant and Lactating women.

研究组 & 干预措施

Experimental: Interventional

Experimental

Group A patients consists of Gingivitis patients whose serum is collected at base line and treated with Scaling and root planing and after three months serum is collected for assessment of Trefoil factor 3.

干预措施: Scaling and root planing (Procedure)

Experimental Interventional

Experimental

Group B patients consists of Periodontitis patients whose serum is collected at base line and treated with Scaling and Root Planing and after three months serum is collected for assessment of Trefoil factor 3.

干预措施: Scaling and root planing (Procedure)

结局指标

主要结局

Trefoil factor 3

时间窗: 3 months.

Blood samples were collected by venepuncture of anti-cubital vein. 2ml of blood was collected in each test tube. 10 minutes after collection, the test tube containing 2ml blood was subjected to centrifugation at 3000rpm for 10 min. The supernatant straw colored fluid (serum) was separated into storage vials (Eppendorf tubes) for serum Trefoil Factor 3.

次要结局

  • Change in the Gingival Index.(3 months)
  • Change in Clinical Attachment loss(3 months)
  • Change in Modified Plaque Index(3 months)
  • Change in Probing depth(3 months)

研究者

发起方
Dr.K.Sai Priyanka
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr.K.Sai Priyanka

Student

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

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