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临床试验/NCT04562545
NCT04562545Unknown不适用

Effect of Incremental Versus Maximum Bite Advancement in Class II Subjects Using Twin Block Appliance : Randomized Clinical Trials

Cairo University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年9月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
24
试验地点
1
主要终点
To asses patient compliance

研究概览

简要总结

The aim of this study is to compare to different protocols to treat Class II malocclusion in growing subjects using the twin block appliance

详细描述

  • Patients will be clinically and radio-graphically examined for eligibility

  • Eligible patients will be randomly assigned to one of two groups:

  • Control Group: Twin Block Appliance fabricated to Maximum Bite Advancement group

  • Intervention Group: Twin Block Appliance fabricated for Incremental Bite Advancement group

  • Records will be taken and impressions will be made and poured. In the control group, bite registration will be made with maximum mandibular advancement. In the intervention group, bite registration is made to habitual bite to make a modified twin block.

  • Patients will be recalled every 6 weeks for 8 months for monitoring and reactivation of the appliance.

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)

盲法说明

Assessor will carry out measurements blindly on pre-operative and post-operative radio-graphs

入排标准

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

入选标准

  • Growing Female Patient
  • Skeletal Class II Malocclusion due to deficient mandible
  • Overjet of 7 to 10 mm
  • Short or normal vertical facial pattern
  • No previous orthodontic nor orthopedic treatment

排除标准

  • Syndromes or Chronic Illness
  • Skeletal Class II Malocclusion due to excessive maxilla
  • Vertical skeletal growth pattern

结局指标

主要结局

To asses patient compliance

时间窗: 8 months

patient will answer a questionnaire at end of treatment

To asses Skeletal and dentoalveolar changes in Mandible

时间窗: 8 Months

Cone Beam CT will be taken before and after active treatment, 3D Cephalometric analysis will be conducted on the Cone Beam to asses Skeletal and Dentoalvoelar changes in mandible. - changes that will be assesed include ( mandibular base length / mandibular antero posterior position in relation to cranial base/ Condylar position / lower incisor inclination to mandibular plane)

次要结局

  • To asses Skeletal and dentoalveolar changes in Maxilla(8 months)

研究者

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

Khaled Mohamed Ali Hussein

Post Graduate Student, Department of Orthodontics, Cairo University

Cairo University

研究点 (1)

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