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临床试验/NCT02810353
NCT02810353Unknown不适用

Analysis of the Dentoskeletal Effects of the Expander With Differential Opening: a Randomized Clinical Trial

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年5月1日最近更新:
适应症
干预措施

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arthur César de Medeiros Alves

University of São Paulo

University of Sao Paulo

研究点 (1)

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