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临床试验/NCT06209125
NCT06209125已完成不适用

Early Correction of Skeletal Class II Division I by the Hybrid Aesthetic Functional Appliances

Mansoura University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022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
16
试验地点
2
主要终点
Early correction of skeletal classII division I by the hybrid aesthetic functional appliances (HAF)

研究概览

简要总结

use new hybrid aesthetic functional appliance for treatment of class II div 1 malocclusion.

详细描述

The Sample:

The sample size was calculated using PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass.

A sample size of 16 data pairs achieves 80.3% power to reject the null hypothesis of zero effect size when the population effect size is 1.00 and the significance level (alpha) is 0.050 using a two-sided paired t-test.

The ten patients will be selected from the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Mansoura University.

The parents of each patient will be informed regarding the study and will sign written consent before starting the treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Age included is the mixed dentition stage ( 6 -12 y )
  • skeletal Class II division
  • Overjet more than 4 mm.

排除标准

  • Previous orthodontic treatment.
  • Bad oral hygiene.

结局指标

主要结局

Early correction of skeletal classII division I by the hybrid aesthetic functional appliances (HAF)

时间窗: one year

early treatment of class II division 1 malocclusion using HAF appliance and evaluate the skeletal and dental effect of new appliance by take cephalogram before and after treatments

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

Sohaila Adnan

Principal Investigator

Mansoura University

研究点 (2)

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