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临床试验/NCT03286569
NCT03286569招募中不适用

Study the Effect of Upper Expansion Appliances on Lower Jaw Forward Projection/Growth

University of Alberta1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Lower jaw projection

研究概览

简要总结

Young children with backward positioned lower jaw/chin will be recruited to have an upper jaw expansion appliance. Previous research showed that the use of similar appliances can lead to lower jaw forward growth. 60 young children aged 9-11 will be recruited to have either active or non-active Wilson type upper arch expansion appliance. Patients will have special x-ray (Cone Beam computed tomography) before and after treatment (after 9 months) of starting the treatment. After participation, routine orthodontic treatment will be continued.

详细描述

Previous research showed that the use of upper jaw expansion appliances can lead to lower jaw forward growth (1). 60 young children aged 9-11 with backward positioned lower jaw/chin will be recruited to have either active or non-active Wilson type upper arch expansion appliance. Patients will have special x-ray (Cone Beam computed tomography) before and after treatment (after 9 months) of starting the treatment. After participation, routine orthodontic treatment will be continued.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
9 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Class II skeletal due to lower jaw backward projection
  • Class II malocclusion
  • Early mixed dentition (all first permanent molars erupted, as well as all erupting upper and lower permanent incisors)

排除标准

  • Other orthodontic treatment provided
  • Growth problems (craniofacial syndromes, etc.)

研究组 & 干预措施

Active upper Wilson appliance

Active Comparator

Active upper arch Wilson quadhelex appliance

干预措施: Upper arch Wilson quadhelex appliance (Device)

Non active upper expansion appliance

Placebo Comparator

Non-Active upper arch Wilson quadhelex appliance

干预措施: Upper arch Wilson quadhelex appliance (Device)

结局指标

主要结局

Lower jaw projection

时间窗: 9 months

Lower jaw projection will be evaluated by computed tomography.

Lower jaw size

时间窗: 9 months

Lower jaw size will be evaluated by computed tomography.

次要结局

  • Base of skull bone position(9 months)
  • Jaw joint size(9 months)
  • Jaw joint position(9 months)
  • Base of skull bone size(9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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