Comparative evaluation of slow maxillary expansion with or without orofacial myofunctional therapy in children with disturbed sleep disorders - A randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Improvement in sleep of the child will be measured by questionnaire
研究概览
简要总结
TITLE - Comparative evaluation of slow maxillary expansion with or without orofacial myofunctional therapy in children with disturbed sleep disorders - A randomized control trial
TYPE OF STUDY - Interventional randomized control trial
PRIMARY OBJECTIVE - To compare the effectiveness of slow maxillary expansion with or without orofacial myofunctional therapy in improving sleep quality in children with disturbed sleep disorders
SECONDARY OBJECTIVE - To assess the change in transpalatal arch width post treatment , to revaluate improvement in airway space using lateral cephalogram , to asses changes in anterior tooth proclination
STUDY DESIGN - 4 arm parellel group, randomised control trial
ALLOCATION simple random sampling using lottery method
Blinding open label
group 1 Removable slow maxillary expansion Hawleys with jack screw
group 2 removable slow maxillary expansion with orofacial myofunctional therapy
group 3 fixed slow maxillary expansion modified palatal expansion appliance
group 4 fixed slow maxillary expansion with orofacial myofunctional therapy
Data collection - department of pediatric and preventive dentistry annoor dental college
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 6 to 12 years Diagnosed with disturbed sleep using BEARS and SDSC tools ENT clearance for dental intervention.
排除标准
- •Children above 12 years Undergoing orthodontic treatment Patient requires skeletal expansion Severe crowding Skeletal cross bite.
结局指标
主要结局
Improvement in sleep of the child will be measured by questionnaire
时间窗: baseline and after 6 months
次要结局
- Trans palatal width will be measured in millimetre from the model.(Pharyngeal space assessment in millimetre lateral cephalogram.)