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临床试验/NCT05773573
NCT05773573已完成不适用

Comparison of Skeletal and Dental Changes with Hyrax-type Rapid Maxillary Expander Anchored to Permanent (6) Versus Deciduous Molars (V) in Growing Subjects

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年5月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Difference in skeletal maxillary width before/ after rapid maxillary expansion

研究概览

简要总结

The aim of the study is to compare the skeletal and dental maxillary expansion obtained with an Hyrax tooth-borne expander anchored either on the 2nd deciduous molars (V) or on the 1st permanent molars (6)

详细描述

The aim of the study is to compare the skeletal and dental maxillary expansion obtained with an Hyrax tooth-borne expander anchored either on the 2nd deciduous molars (V) or on the 1st permanent molars (6).

The main objective is to compare at the skeletal level the distance between the cephalometric points, right jugal (RJ) and left jugal (JR) (maxillary base).

The secondaries objectives are performed at the dental level by measuring the distance between the maxillary first molars mesio-palatal cusp and the cuspids cups. Molar derotation is also assessed

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Patient coming to the dental clinic for a first orthodontic consultation in mixed dentition
  • •Patient aged 6 to 12 years
  • •Patient with a transverse maxillary deficiency requiring rapid maxillary expansion
  • •Presence of 1st permanent molars "6" and 2nd deciduous "V" molars with sufficient root length

排除标准

  • •Syndromic patients (all syndromes combined: cleft lip, etc.)
  • •Patient with V or 6 with decays (or with major root resorption)
  • •Patient with oral hygiene non compatible with orthodontic treatment
  • •Failure to obtain informed written consent
  • •No affiliation to a French national medical health system
  • •Patient with a legal protection measure

研究组 & 干预措施

Experimental group

Experimental

Hyrax-type rapid maxillary expander anchored on the 2nd deciduous molars (V)

干预措施: Experimental group (Device)

Control group

Active Comparator

Hyrax-type rapid maxillary expander anchored on the 1st permanent molars (6)

干预措施: Control group (Device)

结局指标

主要结局

Difference in skeletal maxillary width before/ after rapid maxillary expansion

时间窗: 6 months

Difference in skeletal maxillary width measured on frontal cephs (distance between the cephalometric points "right jugal RJ" and "left jugal JR" of the Ricketts analysis) before (V0)/after (V8) rapid maxillary expansion with tooth-borne expander type Hyrax

次要结局

  • Difference of the inter-molar distance before/after(6 months)
  • Difference of the inter-canine distance before/after(6 months)
  • Difference in the amount of molar derotation (inter-molar angle) before/after(6 months)
  • Inter-operator reproducibility(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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