Does Treating Early Childhood Caries Under Local or General Anesthesia Have Varying Effects on OHRQoL: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Oral health related quality of life OHRQoL
研究概览
简要总结
A two-arm randomized control trial is to compare the changes in OHRQoL scores among children treated for ECC under general (DGA) and local anesthesia (LA). Outcome variable was OHRQoL, measured using the early childhood oral health impact scale ECOHIS and explanatory variable was the administration of local or general anesthesia.
详细描述
Ethical Approval:
The study proposal was registered with the research center at Riyadh Elm University (REU), Riyadh, Saudi Arabia, and ethical approval was obtained from the institutional review board (IRB). Informed consent was obtained from the parents of all participants and the data was managed such that complete confidentiality of the patient was maintained. The current study abides by the regulations presented at the Helsinki declaration.
Sample size calculation:
The sample size required to reject the null hypothesis was estimated using the data from a previous study42 wherein 33.3% of the children with treatment under DGA were reported with better OHRQoL in contrast to 3.3% in the control group. With the alpha set at 0.05, the 80% power of study, and the addition of 30% dropout rate, a sample size of a minimum of 50 children in each group was estimated.
Sample selection criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Arab children
- •Age six years or younger
排除标准
- •Children systemic disease
- •Children with physical and mental disability
- •Children with congenital dental defect such as amelogenesis imperfecta
- •Children with cleft lift/palate
结局指标
主要结局
Oral health related quality of life OHRQoL
时间窗: One year
Oral health related quality of life OHRQoL was measured using the Arabic version of the Early childhood impact scale ECOHIS. This scale has 13 questions and is divided into the child and family impacts. The child impact part includes nine questions under four fields: child OH symptoms, function, psychology and self-image, and social interaction while the family impact part contains four questions under two domains: parental distress and family function. Parents responded to the questions on a 6-point Likert scale (0, never; 1, hardly ever; 2, occasionally; 3, often; 4, very often; and 5, do not know). The overall score was calculated by summing the scores of each item and domain separately with maximum value at (65) . Lower scores indicated better OHRQoL
次要结局
未报告次要终点
研究者
Mohammad Abdullah Alwadaani
Pediatric Dental Resident
Riyadh Elm University