跳至主要内容
临床试验/NCT06589206
NCT06589206尚未招募不适用

Three-Dimensional Assessment of Dentoskeletal Changes Associated With a Modified Twin Block Appliance for Treatment of Skeletal Class II Growing Patients With Mandibular Deficiency: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 30 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
主要终点
skeletal changes

研究概览

简要总结

The aim of the current study is to evaluate the skeletal, dental, soft tissue, TMJ, and upper airway size changes associated with a new design of twin block compared to the conventional twin block appliance. Additionally, patients' satisfaction with the two designs will be assessed.

详细描述

Twin block appliance is the gold standard for the treatment of skeletal class II patients with deficient mandible. Yet, it has some drawbacks as proclination of the mandibular incisors, development of posterior open bite and the unesthetic appearance. Many modifications in twin block A new design were made to overcome the previous problems, as adding incisor capping, Clasps, sagittal blocks, and esthetic twin block appliances. In the current trial A new design of esthetic twin block appliance with sagittal blocks is investigated and the post treatment skeletal, dental, and soft tissue, TMJ, and upper airway size will be assessed and compared to the changes associated with the conventional design of twin block. Moreover, patient satisfaction with the appliance will be assessed with both appliances.

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
10 Years 至 14 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • skeletal class II deficient mandible
  • Class II molar and canine relation
  • male growing patients CVM 2,3 age range 10-14
  • normal vertical growth pattern
  • mild to moderate crowding

排除标准

  • Previous orthodontic treatment.
  • Craniofacial syndrome.
  • Periodontal disease.
  • Extracted first permanent molars.

结局指标

主要结局

skeletal changes

时间窗: 9 months

changes in SNA, SNB, and ANB angles will be measured before and after treatment

Dental changes

时间窗: 9 months

changes in maxillary and mandibular incisors position and inclination will be assessed before and after treatment

次要结局

  • soft tissue changes(9 months)
  • JMJ changes(9 months)
  • Upper airway size(9 months)
  • patient satisfaction(after one and nine months)

研究者

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

Aml Saeed Mohamed Abdel qader

Lecturer Assistant

Cairo University

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