Comparative evaluation of efficacy of modified and conventional mouthguard in preventing orofacial injuries in 8-14 years old children playing skating-A Randomised Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- 1.To evaluate the frequency of fall in children playing roller skating using both type of mouthguard.
研究概览
简要总结
Th This study is a double blinded, parallel group randomised control trial evaluating the efficacy of modified and conventional mouthguard in preventing oro-facial injuries in 8-14 years old children playing skating. Modified mouthguard will be 4mm thick anteriorly and 2mm thick posteriorly whereas conventional mouthguard will be 4mm thick overall. The primary objective is to evaluate the frequency of fall in children playing roller skating us and prevalence of orofacial injuries in children playing skating using both type of mouthguard. The secondary outcome is to assess the knowledge of parents about mouthguard and acceptance of mouthguard by children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 8.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children in the age group of 8-14 years playing roller skating.
- •2.Children whose first permanent molars are erupted.
- •3.Children willing to participate in the study.
- •4.Children willing to use mouthguard while playing roller skating.
- •5.Children who have completed 1 year of training period in roller skating.
排除标准
- •1.Children whose parents didn’t give the written informed consent to participate in the study.
- •2.Children with over-retained teeth and crowding.
- •3.Uncooperative and medically compromised children.
- •4.Children undergoing orthodontic treatment.
结局指标
主要结局
1.To evaluate the frequency of fall in children playing roller skating using both type of mouthguard.
时间窗: 18 months
2.To evaluate the prevalence of oro-facial injuries(traumatic injuries of tooth, jaw fracture, extraoral and intraoral soft tissue injuries) in children playing roller skating using both type of mouthguard
时间窗: 18 months
次要结局
- 1.To evaluate the knowledge of parents regarding the use of mouthguard in children playing roller skating(2.To evaluate the acceptance of modified and conventional mouthguard by children during roller skating)