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临床试验/NCT03082365
NCT03082365Unknown不适用

Prevalence of Oral Findings in Adult Patients With Chronic Kidney Disease '' Cross Sectional 2 "

Maryam Ahmed Essam Abdel Salam0 个研究点目标入组 225 人开始时间: 2017年3月17日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
225
主要终点
Oral mucosal lesions

研究概览

简要总结

The patients with chronic kidney disease suffer from many oral problems affecting the quality of life. The aim of our study is to assess their oral health to provide the proper management and increase their awareness

详细描述

The study will be held in the Nephrology units at the Kasr Al-Ainy Cairo university hospital.

The data collected through the questionnaire will be obtained through an interview between the investigator and the patient. Clinical examination will be performed for both oral (soft tissue) and dental (hard) tissue. For patients undergoing dialysis, examination will be performed before dialysis therapy Selection bias: will be minimized by enrolling the participants in the study in a consecutive order of the entering the clinic.

Non-respondent bias: will be minimized by explaining to the participants the aim of the study and their importance and role in the study.

Incomplete records: will be excluded from statistical analysis with reporting the cause of not completing the record.

Using a precision of 5, a design effect set at 1 with 90% CI (confidence interval), a total sample size of 250 pre-dialysis patients and 200 end stage renal disease patients will be sufficient. The sample size was calculated by Epi info software.The sample will be divided between two researchers; each researcher will have 50% of the whole sample to collect

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

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

入选标准

  • Adult patients >18 years old with a diagnosis of non-dialysis chronic kidney disease at stage 2, 3 and
  • Adult patients >18 years old with a diagnosis of end stage renal disease "stage 5".
  • Recorded data of Glomerular Filtration Rate for every patient.
  • Recorded data for dialysis patients (HCV, platelets count, creatinine, blood urea nitrogen, urea level and partial thromboplastin time).

排除标准

  • Adult patients <18 years.
  • End stage renal disease undergoing peritoneal dialysis.
  • Patients not physically able to participate in oral examination.
  • Patients with kidney transplantation.
  • Patients undergoing renal dialysis for reasons other than chronic kidney disease, such as acute renal failure, accidents, trauma, snake poisoning

结局指标

主要结局

Oral mucosal lesions

时间窗: 15 minutes

Clinical examination according to WHO guidelines

次要结局

  • Periodontal condition(10 minutes)
  • Hepatitis C Virus at dialysis stage(10 minutes)

研究者

发起方
Maryam Ahmed Essam Abdel Salam
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Maryam Ahmed Essam Abdel Salam

BDS internal resident at oral medicine department

Cairo University

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