NCT03497312Unknown不适用
Assessment of Oral Health Related Quality of Life After Full Mouth Rehabilitation Under General Anesthesia in a Group of Egyptian Children With Special Health Care Need (A Before and After Study)
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 14
- 主要终点
- Oral health related quality of life (OHRQOL)
研究概览
简要总结
To assess Oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children with special healthcare need.
详细描述
- The study will be conducted in Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Egypt.
- Demographic variables (caregiver age and gender), socio-economic condition, , medical history, and dental history will be collected from the parent or caregiver. The height and weight of each child will be measured in the same manner to standardize the result and their body mass index will be calculated before and after in follow up period.
- On the day of the GA, parent or caregiver will complete questionnaires about their child's oral state and well-being over the previous 3 months and oral hygiene instructions will be given to the parent.
- The questionnaire will be delivered to the parents/caregivers at baseline and at the 6-month post-operative follow-up visit. Dental examination will be assessed at baseline (pre-operatively) and at 1,3, 6, months post-operative visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 5 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 5 to 14 years.
- •Diagnosed with physical, mental, or sensory disability (separately or combined).
- •Should have a minimum of 12 primary or permanent teeth, or a mixture that had not been treated within the past 12 months.
排除标准
- •Participation in any other concurrent clinical trials.
- •The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.
- •Children whose parents had no home or mobile phone to enable post-operative contact.
- •Parent that will not sign the consent.
结局指标
主要结局
Oral health related quality of life (OHRQOL)
时间窗: at baseline and 6 month
Oral health related quality of life (OHRQOL) will be measured by two validated questioner which are : Parental-Caregivers Perceptions Questionnaire (P-CPQ) and family impact scale(FIS). the unit of measurement is likert scale
次要结局
- Body mass(at baseline and 6 month)
研究者
Duha Mohammed abdelhameed
Doctor Duha Mohammed Abdelhameed pedodontist principle investigator
Cairo University
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