NCT04387175Unknown不适用
Comparison Between an Intraoral Device and Facial Mask for the Early Treatment of Class III Malocclusion: a Randomized Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 主要终点
- Wits appraisal
研究概览
简要总结
The aim of this randomized controlled trail is to compare the efficacy of an intraoral device (the Carriere® Motion 3D™ Class III Appliance) with the facial mask for the early treatemnt of Class III malocclusion. This is a monocentric, parallel, controlled trial with blinded examiner.
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
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 5 and 8 years
- •prepubertal patients (cervical vertebral stage 1 or 2)
- •Deciduous, early mixed, and intermediate mixed dentition (the lower deciduous canine should show at least 2/3 of the roots unresorbed)
- •Presence of Class III skeletal imbalance (Wits appraisal equal to or smaller than
排除标准
- •Early root resorption of the lower deciduous canines
- •Periodontal disease
- •Neurologic diseases
- •Nickel allergy
- •Patients with cleft lip and palate or craniofacial syndromes
- •Patients irradiated in the head and neck area
- •Patients who have undergone chemiotherapy or immunosuppresive therapy in the previous 5 years
- •Patients unable to be followed for at least 1 year
研究组 & 干预措施
Carriere Motion 3D Class III Appliance
Experimental
干预措施: Carriere Motion 3D Class III Appliance (Device)
Facial mask
Active Comparator
干预措施: Facial mask (Device)
结局指标
主要结局
Wits appraisal
时间窗: Change in Wits appraisal evaluated on the lateral cephalograms taken at the start and at the end of active treatment (6-10 months)
Distance between the perpendiculars from points A and B on the maxilla and mandible, respectively, onto the occlusal plane
次要结局
未报告次要终点
研究者
Lorenzo Franchi, DDS, PhD
Associate Professsor
Azienda Ospedaliero-Universitaria Careggi
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