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临床试验/NCT03590067
NCT03590067Unknown不适用

Oral Findings in a Group of Egyptian Pediatric Patients at Endstage Renal Disease Either on Haemodialysis or After Renal Transplantation

Cairo University0 个研究点目标入组 150 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
主要终点
Caries

研究概览

简要总结

In Egypt, the prevalence of end stage renal disease in pediatric population has never been estimated on a national scale. The patients at end stage renal disease encounter oral and dental problems that emphasize regular and careful screening . In Egypt, the prevalence of oral findings is not studied so we conduct this study to study the oral findings among a group of pediatric patients at end stage renal disease either on haemodialysis or after kidney transplantation.

详细描述

Study setting:

  • The study will be held at the center of Pediatric Nephrology and transplantation, El- Mounira children's hospital (Abu El rish).
  • The data collected through the questionnaire will be obtained through an interview between the investigator and the parent or the legal guardian that's based on WHO guide for health surveys(WHO Oral health surveys, 2013)
  • For patients undergoing dialysis, examination will be performed at the dialysis unit during dialysis session (there is no waiting room for patients before dialysis).
  • For patients who received renal transplantation, examination will be performed at the outpatient nephrology clinic during follow up visits.
  • Clinical examination will be performed for both oral (soft tissue) and dental (hard) tissue.
  • Decayed-Missing-Filled Index ( DMF ) which was introduced by Klein, Palmer and Knutson in 1938 and modified by WHO.

The components are:

D component:

Used to describe (Decayed teeth) which include:

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
2 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Pediatric patients <15 years old with a diagnosis of end stage renal disease "stage 5" receiving dialysis.
  • Pediatric Patients < 15 years old with kidney transplantation in the monthly follow up.
  • Recorded data for every patient. (Glomerular Filtration Rate, Creatinine level, urea level and calcium level).

排除标准

  • Patients undergoing renal dialysis for reasons other than chronic kidney disease, such as acute renal failure secondary to accidents, trauma, snake poisoning.
  • Patients undergoing peritoneal dialysis.
  • Patients not physically able to participate in the examination.
  • Chronic kidney disease patients at stage 2, 3 and 4.

结局指标

主要结局

Caries

时间窗: Five minutes

Clinical examination will be done and Caries index will be used ,Unit is the tooth to determine if there is caries or not

次要结局

  • Enamel hypoplasia(Ten minutes)
  • Oral candidiasis(Five minutes)
  • Gingival overgrowth(Five minutes)

研究者

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

Rahma Ali Saber Ali

Dentist

Cairo University

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