Treatment Effects of Invisalign Palatal Expander System and Hyrax Palatal Expander - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Arch width change
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of Invisalign Palatal Expander system ingrowing patients. This study compares the treatment outcomes of Invisalign Palatal Expander system to conventional treatments through randomized controlled trial.
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 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mixed dentition phase with at least three nonmobile (stable) teeth which have more than 1/4 of primary molar root length left16 in either side
- •Early permanent dentition stage and early permanent dentition but second permanent molars not yet fully erupted in the arch
- •Unilateral or bilateral posterior cross bite patients; or Patients who have been diagnosed with transverse maxillary deficiency (Skeletal transverse discrepancy measured from the estimated center of resistances of the first molars17 ≤ - 3 mm);
- •Patients with Class I or Class II skeletal relationship
- •Subjects willing to consent to the trial
排除标准
- •Any general medical health problems which may influence treatment
- •Any craniofacial anomalies
- •Skeletal Class III patients
- •Mixed dentition patients with more than 2 heavily restored primary second or permanent first molars.
研究组 & 干预措施
Invisalign® Palatal Expander System
Invisalign® Palatal Expander System will be delivered.
干预措施: IPE (Device)
Hyrax-type maxillary expander
Hyrax-type maxillary expander will be delivered. The Hyrax-type maxillary expander will include a midline self-locking screw, which is connected to the conventional molar bands or printed clasps, which are cemented on the maxillary first molars (or on the maxillary primary second molars), via 0.9 mm stainless-steel wire. The framework is soldered to the bands and extends on the palatal side to the primary canines or canines. The expander will be fabricated by a qualified laboratory technician
干预措施: HE (Device)
结局指标
主要结局
Arch width change
时间窗: 12-18 months
Arch width change measured on digital study casts
Width change
时间窗: 12-18 months
Transverse changes on CBCTs
次要结局
- Cephalometric changes(12-18 months)
研究者
Heeyeon Suh
Assistant professor
University of the Pacific