跳至主要内容
临床试验/NCT04429113
NCT04429113已完成不适用

Is the Quad Helix More Efficient to Correct Mandibular Asymmetry Before Age 7? A Retrospective Comparative Study

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
1
主要终点
Difference in the mandibular corpus length between the right and left side

研究概览

简要总结

To compare the effectiveness of the Quad Helix, an orthopaedic conventional appliance, in the correction of skeletal mandibular asymmetry, on frontal x-ray, in subjects treated before or after 7 years.

详细描述

Introduction

Unilateral posterior crossbite (UPCB), often from dysfunctional and para-functional causes, leads to positional mandibular asymmetries that can develop at a very young age into skeletal mandibular deviation; hence the interest of early maxillary expansion. The purpose of this retrospective study was to compare the impact of maxillary expansion by Quad Helix (QH) on mandibular skeletal asymmetry correction before and after 7 years of age.

Materials and methods

All children with UPCB and skeletal mandibular asymmetry, who were treated by QH in the orthodontic department between February 2017 and August 2018 and who have done a radiography file at baseline (T0) and 12 months later (T1) have been included. The patients were divided into two groups according to age: under 7 years of age (early group G1) with QH adjusted on second primary molars and over up to 13 years old (late group G2) with QH adjusted on first permanent molars. The differences between the right and left sides of the mandible in corpus length L (main eligibility criterion) and ramus height H (secondary criterion) were compared between groups. X² test, Fisher's exact test and Wilcoxon rank-sum tests were used for baseline comparisons. A multifactorial analysis allowing adjustment on possible confounding factors was used with R software at a significance level of 5%.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
4 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Difference in the mandibular corpus length between the right and left side

时间窗: 1 day

Difference in the mandibular corpus length between the right and left side : △L on conventional frontal x-ray.

次要结局

  • Difference in the mandibular ramus height between the right and left side of the mandibule(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Quad Helix and Correction of Mandibular Asymmetry | 临床试验