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临床试验/NCT04255511
NCT04255511已完成不适用

Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion Children on Pharyngeal Airway and Nocturnal Breathing ; Randomized Controlled Trial

Mansoura University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年12月10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
50
试验地点
2
主要终点
Pharyngeal airway volume

研究概览

简要总结

This study aims at evaluating the effects of mandibular advancement on pharyngeal airway space and nocturnal breathing in children with skeletal class II division1 malocclusion. Fifty patients will be enrolled in the study divided into control and experimental groups.

详细描述

The purpose of the present research is not only evaluate the effect of functional appliance on the pharyngeal airway space, but also evaluate its effect on nocturnal breathing of children with skeletal class II.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Skeletal class II division 1 malocclusion due to mandibular retrognathism.
  • Cephalometric angular measurements: SNA ≥ 82, SNB ≤ 78, ANB ≥
  • Overjet ≥ 6 mm.
  • Patient in circumpubertal stage CVM2 and CVM3.

排除标准

  • History of orthodontic treatment.
  • Presence of craniofacial anomalies or TMJ disorders.
  • Systemic problems that may affect craniofacial growth.
  • Abnormal oral habits.

结局指标

主要结局

Pharyngeal airway volume

时间窗: One year

CBCT images will be used to measure the pharyngeal airway volume in mm3

Nocturnal breathing

时间窗: One year

Pulse oximeter will be used to measure Oxygen Desaturation Index (ODI) and report the number of 3% and/or 4% desaturations.

次要结局

  • Maximum expiratory pressure(One year)
  • Craniofacial changes(One year)

研究者

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

Mona Montasser

Professor of Orthodontics

Mansoura University

研究点 (2)

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