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临床试验/NCT06409923
NCT06409923招募中1 期

Comparison of Skeletal Effects of Herbst and Invisalign MA in Growing Patients With KLass Malocclusion

Université Libre de Bruxelles4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年2月14日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
入组人数
30
试验地点
4
主要终点
Mandibular lenghtening

研究概览

简要总结

This study aims to determine and compare the precise skeletal dental and soft tissue effect of Mandibular advancement aligners and Herbst Appliance.

详细描述

Precise description of study methodology.

For each group, a sample of +- 15 patients with class 2 malocclusion aged between 9 and 15 years will be collected for this prospective study who presented for an initial orthodontic consultation between October 2022 and july 20262 at ULB's Erasme Hospital. Each patient will be treated with Invisalign MA or the Herbst appliance by residents of the orthodontic program directed by P. Maria Orellana

Inclusion criteria included a Class II skeletal malocclusion with an ANB greater than 4°; (In the case of a Class 2 Division 2 malocclusion, the retroclined upper incisors will be proclined to obtain an overjet allowing mandibular advancement. If the patient has a transverse deficit, palatal expansion will be performed before treatment with aligners and during treatment in herbst cases.) Class II molar and canine relationship and CVM2/CVM3 cervical vertebral maturation.

Informed consent forms in the patient's native language will be submitted before the start of each treatment.

Only a profile cephalometry will be taken in the patients considered for this study at the time of the initial consultation.

研究设计

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

入排标准

年龄范围
— 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • periodontal disease

结局指标

主要结局

Mandibular lenghtening

时间窗: Difference between T1/T2. T1: Before Mandibular advancement phase, T2: Minimum 1 year after T1 and 2 months without mandibular advancement.

次要结局

未报告次要终点

研究者

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

Paul-Henry Casselman

Postgraduate student Dentofacial orthopedics and orthodontics

Université Libre de Bruxelles

研究点 (4)

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