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Oral Findings in a Group of Egyptian Pediatric Patients at Endstage Renal Disease

2019年7月29日 更新者:Rahma Ali Saber Ali、Cairo University

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

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.

研究概览

地位

未知

详细说明

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:

Carious tooth. Filled tooth with recurrent decay. Only the roots are left. Defect filling with caries. Temporary filling. Filled tooth surface with other surface decayed.

M component:

Used to describe (Missing teeth due to caries) other cases should be excluded.

F component:

Used to describe (Filled teeth due to caries). Teeth were considered filled without decay when one or more permanent restorations were present and there was no secondary (recurrent) caries or other area of the tooth with primary caries. A tooth with a crown placed because of previous decay was recorded in this category. Teeth stored for reason other than dental caries should be excluded.

deft / defs , which was introduced by Gruebbel in 1944

d- decayed tooth . e- decayed tooth indicated for extraction . f- filled tooth

• The coding system for the Modified DDE Index has three items of information that will be recorded for each tooth surface. (Clarkson and O'Mullane, 1989)

First, the Type of Defect, codes 0-7, was recorded. Then the Sub-type of that defect was noted, i.e., when a demarcated opacity was present, the Sub-type was either white/cream (code 1) or yellow/brown (code 2), or when a diffuse opacity was present, then six options were possible. Finally, the extent of each defect was recorded. The new additional sub-type (code 3) termed "diffuse confluent opacity" is defined as a diffuse opacity in which any patchiness has merged into a regular condensed chalky white area, and it could cover the entire surface of a tooth or be confined to a localized area of the tooth surface.

  • Oral candidiasis assessment will be based on the Lehner scale (Cleverson et al., 2014)
  • In assessing the degree of gingival hyperplasia we will use the index of Angelopoulos and Goaz, described by Prof. T. Djemileva. (Dencheva et al., 2011)

研究类型

观察性的

注册 (预期的)

150

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2年 至 14年 (孩子)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All pediatric patients at end stage renal disease attending at the center of Pediatric Nephrology and transplantation, El- Mounira children's hospital (Abu El rish) will be enrolled in the study in a consecutive order according to inclusion criteria.

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Heamodialysis group
The data will be collected through a questionnaire that will be obtained through an interview between the investigator and the parent or the legal guardian
Kidney transplantation group
The data will be collected through a questionnaire that will be obtained through an interview between the investigator and the parent or the legal guardian

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Caries
大体时间: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
Five minutes

次要结果测量

结果测量
措施说明
大体时间
Enamel hypoplasia
大体时间:Ten minutes
Clinical examination will be done on each patient to assess enamel hypoplasia and recorded by use of Modified Developmental Defect of Enamel (DDE) Index
Ten minutes
Oral candidiasis
大体时间:Five minutes
Clinical examination will be conducted to assess oral candidiasis and recorded by use of Lehner Oral Candidiasis Classification
Five minutes
Gingival overgrowth
大体时间:Five minutes
Clinical examination will be done to asess gingival overgrowth and recorded by use of Angelopoulos and Goaz index
Five minutes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2019年11月1日

初级完成 (预期的)

2019年12月1日

研究完成 (预期的)

2020年1月1日

研究注册日期

首次提交

2018年6月29日

首先提交符合 QC 标准的

2018年7月16日

首次发布 (实际的)

2018年7月18日

研究记录更新

最后更新发布 (实际的)

2019年7月31日

上次提交的符合 QC 标准的更新

2019年7月29日

最后验证

2019年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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Questionnaire的临床试验

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