Child Discomfort and Parental Acceptability of Silver Diamine Fluoride and Alternative Restorative Treatment: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain perception
研究概览
简要总结
The aim of the current study was to compare pain perception of young children treated with SDF and ART, as well as their parents' acceptability of both modalities.
详细描述
Eighty, 3-8-years-old children, having at least one deciduous asymptomatic tooth with active caries were randomly assigned into 2 groups; SDF for caries arresting in the test group, and ART for caries removal in the control group.
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
- None
入排标准
- 年龄范围
- 3 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Negative and definitely negative behavior according to Frankl's behavior rating scale.
- •Having at least one deciduous asymptomatic tooth with active caries, as defined by the International Caries Detection and Assessment System; ICDAS II scores 4, 5, 6.
排除标准
- •Children who suffered from silver allergy, oral ulcerations, pulpal infections and whose parents needed immediate permanent restorations.
研究组 & 干预措施
Silver Diamine Fluoride
干预措施: SDF (Drug)
Atraumatic Restorative Treatment
干预措施: ART (Drug)
结局指标
主要结局
Pain perception
时间窗: 6 months
Pain reaction was assessed using the Sound, Eye, Motor scale (SEM) according to Wright et al. criteria. It is an objective method for pain assessment, where the child's level of anxiety was evaluated according to three types of observations. The score in each category ranged from one (no pain) to four (intense pain). A lower score represents less physical reaction to the procedure than does a higher value. Time of treatment was recorded using a stopwatch.
次要结局
- Parents' acceptability of the treatment modality(2 weeks)
研究者
Nourhan M.Aly
Assistant Lecturer of Dental Public Health
University of Alexandria