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临床试验/NCT04812990
NCT04812990已完成不适用

A Cross Sectional Observational Study on Relation Between Oral Manifestation and Hepatitis C in Egypt

Misr University for Science and Technology1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年3月1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
100
试验地点
1
主要终点
oral lesion relation to hepatitis c

研究概览

简要总结

Hepatitis C virus (HCV) is the major cause of chronic liver disease and has a long-term resultant complications4 and it considered as a major endemic medical health problem in Egypt. It affects multiple organs and reflect various manifestations on oral cavity.The purpose of this study is to assess the prevalence of oral mucosa conditions, type of oral manifestation and gingival lesions in patients with hepatitis C

详细描述

Study design: It is a cross sectional observational study. Sample size estimation: 100 patients (50 in each groups) A total of 100 adult participants of both genders above 18 years will be included in the study, patients was able and willing to participate in the study. 50 patients will be recruited for study group from consecutive patients previously diagnosed by hepatitis C regardless of the etiology of the condition and regularly attending at Soad Kafay hospital. Participants with history of smoking and alcoholism that could affect their oral health status were excluded. The control group populations will be randomly recruited from the out-patient of dental diagnosis clinic in Misr University For science & technology university to include total 50 clinically healthy participants, with no history of liver disease, or any other chronic debilitating illness, or habit of smoking or drinking, , as well as history of an intervention or condition that could affect the oral mucosa (e.g., history of radiotherapy and/or not receiving any medication that could affect oral health.

Changes in the oral cavity was recorded on the entire mucosal surface recording signs, symptoms, and oral lesion absence or presence. All the information will be recorded and the data will be analyzed after the end of the study . The prevalence of various oral manifestations in hepatitis C patients will be documented.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients previously diagnosed with hepatits c, with education, ability and willing to participate in the study

排除标准

  • Patients with systemic diseases such as nutritional deficiency; cardiovascular, respiratory, metabolic, and endocrinal disorders; also smoking and alcoholism that could affect their oral health status were excluded. As well as history of an intervention or condition that could affect the oral mucosa (e.g., history of radiotherapy).

结局指标

主要结局

oral lesion relation to hepatitis c

时间窗: six months

the prevalence to oral lesions related to hepatitis C 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

Radwa Elsherif

LECTURER

Misr University for Science and Technology

研究点 (1)

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