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临床试验/NCT07161596
NCT07161596尚未招募不适用

Oral Health Status and Oral Health Related Quality of Life of a Group of Hemophilic Egyptian Children Before and After an Oral Health Educational Program: A Before and After Study

Cairo University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
1
主要终点
oral health status in Egyptian hemophilic children

研究概览

简要总结

aim of the study:

  1. to assess, investigate, and compare the oral health status and oral health related quality of life of a group of hemophilic Egyptian children before and after an oral health educational program
  2. evaluate the effectiveness of oral health educational programs on the oral health status of the Egyptian hemophilic children

benefits to patients: oral health awareness and change in the oral care levels with methods that match their health needs benefits to clinician: better understanding of the oral conditions associated with hemophilic patients, and their effects on oral health benefits to community: improvement of children's oral health, oral health awareness, promoting the importance of regular dental check ups for children with hemophilia

详细描述

In a non randomized clinical trial, Egyptian hemophilic children will be submitted to this trial to assess and measure their oral health status and oral health related quality of life prior to an oral health educational program. two groups will be formulated; the hemophilic group that will take the oral health educational program and the control group (other group) wont be taking the oral health educational program, then control will be given the oral health educational program after the follow up period for a better oral health in the hemophilic community. the oral health status will be recorded using two indices; DMF and def Caries indices and the oral hygiene index simplified (OHI-S) at baseline and at 8 months follow up period. bimonthly visits will be scheduled to check on the hemophilic children oral health and following up on given oral hygiene instructions. the oral health educational program is a tailored program guided by the American academy of pediatric dentistry, the oral considerations in the world federation of hemophilia , and oral care program of the Egyptian society of hemophilia in Egypt. diet counselling will be given. after the 8 months following the oral health educational program, oral health status and oral health related quality of life will be measured in both group and the results will be recorded. Aim of the study is a better oral health care and better understanding on how to apply oral hygiene measures correctly in hemophilic children.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Screening
盲法
None

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •both sexes having hemophilia A,B or C
  • •no associated co morbid diseases
  • •mild, moderate and severe forms of hemophilia
  • •children whose parents agreed to participate in the study

排除标准

  • •patients with psychiatric disorders
  • •children whose parents refused to participate in the study
  • •patients using drugs( as cyclosporine, phenytoin) inducing periodontal problems

研究组 & 干预措施

hemophilic children: no oral health educational program (no intervention)

No Intervention

for ethical considerations; no intervention group will be given the oral health educational program after the follow up oral health status indices are measured

hemophilic children: oral health educational program as intervention

Experimental

An oral health educational program delivered to hemophilic Egyptian children as the main intervention guided by the oral and dental care instructions recommended by the American Academy of Pediatric Dentistry (AAPD) and the World Federation of Hemophilia (WFH), and the oral care program by the Egyptian society of hemophilia

干预措施: oral health educational program (Behavioral)

结局指标

主要结局

oral health status in Egyptian hemophilic children

时间窗: baseline

Oral Health Status 1. Dental Caries in Permanent Teeth (Decayed, Missing, and Filled Teeth Index) The Decayed, Missing, and Filled Teeth index records the number of decayed, missing due to caries, and filled permanent teeth. A mean score is calculated for the study group. Mean DMFT score. Minimum value: 0 - Maximum value: 28. Higher scores indicate worse oral health status. 2. Dental Caries in Primary Teeth (Decayed, Extracted, and Filled Teeth Index) The Decayed, Extracted, and Filled Teeth index records decayed, extracted due to caries, and filled primary teeth. A mean def score is reported for the study group. Minimum value: 0 - Maximum value: 20. Higher scores indicate worse oral health status. 3. Oral Hygiene Status (Oral Hygiene Index-Simplified) The Oral Hygiene Index-Simplified combines debris and calculus scores to assess oral hygiene status Mean score. least value: 0 - Max:6 Lower score indicate better oral hygiene, and higher scores indicate worse oral hygiene.

次要结局

  • oral health related quality of life of a group of Egyptian hemophilic and non hemophilic children(baseline)

研究者

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

Hoda Hatem Abdelmoniem Ibrahim Atteya

Masters Student

Cairo University

研究点 (1)

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