NCT06662279招募中不适用
Hyrax Vs. Invisalign Palatal Expander Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 8
- 主要终点
- width of palate after expansion
研究概览
简要总结
The purpose of this study is to compare expansion result and the overall experience between the Invisalign Palatal Expander and the Hyrax expander.
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
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject ages 6-11 years old
- •Subject must need maxillary expansion
- •Subjects must have erupted dentition in the area of the primary molars or permanent premolars and the first permanent molar
排除标准
- •Subjects with palatal exostosis/surface aberration/ cleft palate
- •Subject's dentition not compatible with device or allergy to device materials
- •Subject with active caries, periodontal disease, TMD
结局指标
主要结局
width of palate after expansion
时间窗: from enrollment to study completion, approximately 4 months
intraoral scans will be taken of the subject's upper arch, including palate throughout the study and widths will be measured
次要结局
未报告次要终点
研究者
研究点 (8)
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