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临床试验/NCT07665047
NCT07665047尚未招募不适用

Assessment of Caries Impacts and Experiences in a Visually Impaired Versus Sighted Pediatric Population Using a Caries-Specific Quality-of-Life Questionnaire: A Comparative Cross-sectional Study

Cairo University0 个研究点目标入组 140 人开始时间: 2026年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
140

研究概览

简要总结

The goal of this observational study is to to compare dental caries impacts and experience among visually impaired and sighted children. The main question it aims to answer is:

Among schoolchildren aged 6-14 years, does visual impairment compared to normal sight lead to poorer caries experiences and lower caries-related quality of life?

详细描述

This observational study aims to compare the quality of life between &caries experience visually impaired and sighted children

Visually impaired people may be at a higher risk of developing oral diseases due to various limitations in activities and perception. In accordance with the WHO Global strategy and action plan on oral health 2023-2030, it is necessary to advance research on people with disabilities to identify the limitations and their consequences in receiving dental health as well as in maintaining good oral health.

Our pilot study showed mean CARIES-QC/A scores of 9.7 ± 7.3 for the visually impaired group and 4.1 ± 3.5 for the sighted group. While this points to a large effect size (d = 0.98), pilot data often inflate these numbers. To avoid an underpowered study, we adopted a more conservative, medium effect size (d = 0.5) for our calculations. This requires a minimum of 63 participants per group. To account for potential dropouts or incomplete data, we rounded our final target up to 70 participants per group.

Caries-related quality of life will be assessed as a primary outcome using CARIES-QC, which is administered to participants through an interview. while the secondary outcome, which is Caries Experience, will be assessed using DMF index for permanent dentition and DMF & def index for mixed dentition Data collected will be saved and tabulated on a computer for backup and finally statistically analyzed.

the finding of this study aims to increase awareness, guide public health programs, reduce dental disease burden, strength school-community partnerships, and promote equity in oral healthcare for visually impaired children.

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

入选标准

  • Children's age ranges from 6 to 14 years.
  • Apparently healthy children
  • Parents' acceptance of their children's participation in the study.

排除标准

  • Children on long-term medication.
  • Parents who refuse to participate in the study

研究者

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

Souty Emad Waheeb

Principle investigator

Cairo University

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