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临床试验/NCT03839303
NCT03839303Unknown不适用

Infra-zygomatic Mini Implant Supported Appliance for Distalization and Intrusion of Maxillary Dentition Compared to Headgear in Growing Patients: A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年3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
26
试验地点
1
主要终点
Anteroposterior position changes of the maxilla

研究概览

简要总结

The aim of the study is to compare an Infra-zygomatic Mini implant supported appliance with headgear in distalization and intrusion of maxillary dentition for treatment of growing patients with class II malocclusion (maxillary excess)

详细描述

In this randomized trial, 2 groups will be included. The first group will receive an Infra-zygomatic Mini implant supported appliance. In the second group, the patient will receive a removable high pull headgear. the follow-up period will be 8 months or till class I canine or incisors relation is obtained. the assessment will be through a lateral cephalogram

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 15 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Growing patients ( cervical vertebrae maturation stage cs2-cs3 )
  • Maxillary excess
  • Minimum overjet 4 mm
  • class II canines or incisors
  • Increased incisal show at rest and on smiling
  • Normal and increased vertical growth pattern
  • No previous orthodontic treatment
  • No congenitally messing teeth except third molars

排除标准

  • Inadequate incisal show
  • Class II with deficient mandible and normal maxilla
  • Patients with any syndrome
  • Patients with horizontal growth pattern

研究组 & 干预措施

Mini Implant Supported Appliance

Experimental

this group will receive an Infra-zygomatic Mini Implant Supported Appliance after leveling and alignment of the four upper incisors for 8 months or till class I canine or incisors realation is reached with follow up every month

干预措施: Infra-zygomatic Mini Implant Supported Appliance (Device)

Headgear

Active Comparator

this group will receive a high pull headgear appliance attached to a removable acrylic maxillary splint for 8 months or till class I canine or incisors realation is reached with follow up every month

干预措施: high pull head gear (Device)

结局指标

主要结局

Anteroposterior position changes of the maxilla

时间窗: 8 months

Measurements on the lateral cephalogram

Anteroposterior position changes of upper first molars.

时间窗: 8 months

Measurements on the lateral cephalogram

次要结局

  • Vertical position changes in maxilla(8 months)
  • Position changes of upper incisors(8 months)
  • Vertical position changes of upper first molars(8 months)
  • Anteroposterior skeletal changes in mandible(8 months)

研究者

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

Ahmed Khaled Mohamed Mohamed

Resident in orthodontic department of Cairo University

Cairo University

研究点 (1)

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