Evaluating the Effectiveness of a U-shaped Toothbrush in Removing Plaque In Pre-school Children
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changing in plaque index
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of a U-shaped toothbrush in removing plaque in preschool children which can be a simple, acceptable, and effective way to remove plaque in children in order to improve their oral health in the absence of parental supervision.
Children accepted in the study will be randomly divided into two groups:
The traditional toothbrush group and the U-shaped toothbrush group, All children aged four to five years will have their plaque assessed with the Turesky Modified Quigley Hein Index (TMQH)
详细描述
This study will evaluate the effectiveness U-shaped toothbrush in removing plaque and improving oral health. Children were randomly assigned to one of the following groups:
Group A: children in this group will use a traditional brush first to clean their teeth then will use U shaped brush later.
Group B: children in this group will use a U-shaped brush first to clean their teeth then will use a traditional brush later The plaque will be assessed by a blinded evaluator using the Turesky Modified Quigley Hein index (TMQH) in both groups at 4 different times(T0): before brush (T1): after brush (T2): a week after use (T3): a month of use The toothbrush will be changed after one month of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically free children. Complete temporary occlusion (no missing temporary teeth). The parents' approval for the child to enter the study.
排除标准
- •Children with limited ability to communicate. Children with motor disabilities.
结局指标
主要结局
Changing in plaque index
时间窗: Plaque index will be measured before brushing (T0) and after brushing in both groups on the first day (T1), a week after use (T2), and after a month of use (T3) with each toothbrush
0 No plaque,1 Isolated flecks of plaque at the gingival margin, 2 A continuous band of plaque up to 1mm at the gingival margin, 3 Plaque greater than 1mm in width and covering up to one third of the tooth surface, 4 Plaque covering from one thirds to two thirds of the tooth surface, and 5 Plaque covering more than two thirds of the tooth surface
次要结局
未报告次要终点