Analysis of the Dentoskeletal Effects of the Expander With Differential Opening: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Maxillary and mandibular inter-first permanent molar distances
研究概览
简要总结
This study evaluates the dentoskeletal effects of the expander with differential opening in orthodontic patients in the mixed dentition. Half of participants will undergo rapid maxillary expansion (RME) using the expander with differential opening, while the other half will undergo RME using the conventional Hyrax expander.
详细描述
Recently, a rapid maxillary expander with differential opening was developed aiming to treat maxillary constrictions greater in the anterior region compared to the posterior region of the maxillary dental arch. The aim of this study is to evaluate the dentoskeletal effects of the expander with differential opening in orthodontic patients in the mixed dentition. Material and methods: Fifty patients with maxillary constriction in the mixed dentition will be prospectively and randomly allocated in one of two study groups. The experimental group will comprise 25 patients who will be submitted to rapid maxillary expansion with the expander with differential opening. The control group will be comprised by 25 individuals who will undergo rapid maxillary expander with the Hyrax expander. Digital dental models will be acquired immediately pre-expansion (T1) and six months post-expansion (T2). The Orthoanalyzer™ software will be used to measure maxillary and mandibular widths, arches perimeter, arches lengths, palatal depth, and inclinations of maxillary and mandibular canines and permanent first molars. The intergroup and interphase comparisons will be analyzed using t tests and paired t tests, respectively (p<0.05).
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
- 7 Years 至 11 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes;
- •Ages ranging from 7 to 11 years old;
- •Mixed dentition;
- •Maxillary constriction;
- •No previous orthodontic treatment.
排除标准
- •Cleft lip and palate and associated syndromes;
- •Systemic and/or neurological diseases.
研究组 & 干预措施
Expander with differential opening group
The experimental group will comprise 25 patients who will be submitted to rapid maxillary expansion using the expander with differential opening. The expander will be composed by two 11-mm screws, one anteriorly and the other posteriorly positioned on the palate (Great lakes Orthodontics Ltd, NY, EUA).
干预措施: Differential rapid maxillary expansion (Device)
Hyrax group
The control group will be comprised by 25 patients who will undergo rapid maxillary expansion using the conventional Hyrax expander. The expander will be composed by one 11-mm screw centrally positioned on the palate (Dentaurum, Ispringen, Germany).
干预措施: Conventional rapid maxillary expansion (Device)
结局指标
主要结局
Maxillary and mandibular inter-first permanent molar distances
时间窗: 6 months
Maxillary and mandibular inter-second deciduous molar distances
时间窗: 6 months
Maxillary and mandibular inter-first deciduous molar distances
时间窗: 6 months
Maxillary and mandibular inter-deciduous canine distances
时间窗: 6 months
Maxillary and mandibular dental arches perimeters
时间窗: 6 months
Maxillary and mandibular dental arches lengths
时间窗: 6 months
Palatal depth
时间窗: 6 months
Inclination of maxillary and mandibular first permanent molars
时间窗: 6 months
Inclination of maxillary and mandibular deciduous canines
时间窗: 6 months
Amount of interincisor diastema
时间窗: 10 days
次要结局
- Amount of differential expansion on the maxillary and mandibular dental arches(6 months)
研究者
Arthur César de Medeiros Alves
University of São Paulo
University of Sao Paulo
