NCT06574490尚未招募不适用
Effectiveness of Myofunctional Therapy in Children With Open Bite - a Randomized Clinical Trial
Piotr Fudalej0 个研究点目标入组 80 人开始时间: 2024年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Overbite
研究概览
简要总结
The goal of this clinical trial is to learn if myofunctional therapy in 6-10-year-old children with infant type of swallowing and open bite is effective.
Primary hypothesis: myofunctional therapy results in correction of open bite Researchers will compare a group in which myofunctional therapy is performed for 6 months to a group in which myoufunctional therapy will be delayed by 1 year.
Participants will exercise according to a pre-established regimen and schedule
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •generally healthy children aged 6-10 years,
- •infant swallowing type,
- •open anterior occlusion (i.e. no contact between the maxillary and mandibular medial incisors),
- •mixed dentition
排除标准
- •finger sucking habit (or similar) occurring within the last 6 months,
- •previous myofunctional therapy,
- •upper airway obstruction,
- •congenital craniofacial developmental disorder,
- •connective tissue or muscle disease,
- •macroglossia,
- •ankyloglossia,
- •mental retardation
结局指标
主要结局
Overbite
时间窗: 12months
presence positive vertical (i.e. the upper teeth overlap the lower teeth) and horizontal (i.e. the upper teeth are positioned in front of the lower teeth) occlusion
次要结局
- Swallowing pattern(12 months)
- Articulation(12 months)
研究者
Piotr Fudalej
Professor
Jagiellonian University
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