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临床试验/NCT03462953
NCT03462953Unknown不适用

Localization of Indicators for Epithelial Mesenchymal Transformation in Gingiva From Chronic Periodontitis Patients as Compared to Healthy Individuals (Case Control Study)

Cairo University0 个研究点目标入组 36 人开始时间: 2018年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
36
主要终点
Localization of EMT indicators TGF- β1, Vimenten, E-Cadherin

研究概览

简要总结

The current study focuses on the localization and quantitative assessment of growth factors and cytokines related to the EMT process found in the human gingival tissue samples taken from periodontally diseased individuals compared to other samples taken from healthy individuals. Through this investigation the correlation between the severity of the disease and the amount of these factors will be studied aiming to alleviation of the high prevalence of periodontal diseases among the Egyptian population.

详细描述

In a case control human study The existence and the amount of the indicators and cytokines for EMT in the gingival tissue samples taken from the periodontitis patients will be investigated and compared to those in healthy individuals using histopathology and real time PCR to reveal the role of these factors in periodontal disease incidence in humans.

Total of 36 participants will be recruited in this study The participants will be divided according to their periodontal status into four groups (healthy, mild, moderate and severe periodontitis) 9 patients in each group.

The periodontal screening of patients will be done using mouth mirror and graduated Williams's periodontal probe for the following:

  • Gingival status will be assessed by using gingival index
  • Periodontal pocket depth.
  • Clinical attachment loss.
  • Radiographic examination using panoramic technique. Screening criteria for chronic periodontitis was the presence of at least 5 sites with 4 mm horizontal alveolar bone loss on radiographs.

Gingival tissue samples will be harvested during periodontal surgery and extraction of the periodontally hopeless tooth for the periodontitis patients and during the premolar extraction (Orthodontic ttt) or third molar extraction for the healthy controls.

研究设计

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

入排标准

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

入选标准

  • Inclusion criteria for healthy group:
  • Absence of any clinical sign of gingival inflammation
  • Probing depth ≤3 mm
  • No clinical attachment loss.
  • Inclusion criteria for periodontitis group:
  • Generalized presence of clinical signs of gingival inflammation
  • Generalized probing depth ≥4 mm
  • Generalized clinical attachment loss of ≥2 mm.

排除标准

  • • Patients with any systemic disease,
  • Pregnant or lactating women,
  • Cervical/proximal/subgingival caries or restorations,
  • Periodontal or antimicrobial therapy within 3 months before sampling.

研究组 & 干预措施

periodontally diseased individuals

Placebo Comparator

Gingival tissue samples will be harvested during periodontal surgery and extraction of the periodontally hopeless tooth for the periodontitis patients.

干预措施: Gingival tissue samples will be harvested (Procedure)

individuals with healthy gingiva

Placebo Comparator

Gingival tissue samples will be harvested during the premolar extraction (Orthodontic ttt) or third molar extraction for the healthy controls.

干预措施: Gingival tissue samples will be harvested (Procedure)

结局指标

主要结局

Localization of EMT indicators TGF- β1, Vimenten, E-Cadherin

时间窗: one year

using real time PCR the EMT indicators will be identified and quantified in all the gingival samples taken from patients of both arms of the study

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

Karim wasfi wadiea

Instructor at oral biology department at Mti university

Cairo University

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