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临床试验/NCT03824574
NCT03824574已完成不适用

Cephalometric Evaluation of a Clear Mandibular Advancement Appliance Based on the Twin-block Design

Ain Shams University0 个研究点目标入组 20 人开始时间: 2016年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
主要终点
Maxilla to cranial base

研究概览

简要总结

This study evaluates the cephalometric effects of a clear mandibular advancement appliance for the treatment of skeletal class II growing patients suffering from mandibular deficiency.

详细描述

A Clear mandibular advancement appliance is constructed comprised of a clear dental splint of 1.5 mm thickness adapted on the patient's teeth. This is followed by the construction of acrylic bite ramps bonded over the splints. The bite ramps are constructed as such when the patient bites into occlusion, he/she has to advance the mandible to bring the two parts of the appliance together. Lateral cephalometric radiographs were obtained pre and post-treatment to evaluate the effects on the patient's maxilla, mandible and dentition.

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
Female
接受健康志愿者

入选标准

  • Gender: Female subjects.
  • Chronological age: All recruited subjects were between the ages of 8-12 years.
  • Anteroposterior skeletal relationship: Subjects with skeletal Class II malocclusion with normal maxilla and retrognathic mandible were selected. This was confirmed using lateral cephalometric radiographic analysis with the following parameters: decreased effective mandibular length (Co-Gn) according to McNamara composite , SNB<78, SNA=82+
  • Dental characteristics:
  • Angle Class II molar relationship ranging from edge to edge to full unit Class II.
  • Overjet ranging between 5-10 mm.
  • Absence of posterior crossbite and/or tendency for posterior crossbite.
  • Skeletal maturation stage: The growth stage for all subjects was selected to be before or at the prepubertal growth spurt. This was confirmed by cervical vertebral maturation analysis from the lateral cephalometric radiograph. The cervical vertebrae maturation stage required was Cervical Vertebrae Maturation stage 2-3 according to the cervical vertebrae maturation index by Baccetti et al. allowing sufficient time before the end of the growth spurt.
  • No previous history of orthodontic treatment.
  • Absence of systemic diseases affecting growth or craniofacial development. -

排除标准

  • 未提供

研究组 & 干预措施

Treatment arm

Experimental

Subjects receiving the clear mandibular advancement appliance

干预措施: Clear Mandibular Advancement Appliance (Device)

结局指标

主要结局

Maxilla to cranial base

时间窗: 12 months

Sella-Nasion-A point

Effective Mandibular Length

时间窗: 12 months

Condylion-Gnathion

Mandible to cranial base

时间窗: 12 months

Sella-Nasion-B point

Effective maxillary length

时间窗: 12 months

Condylion-A point

次要结局

  • Chin position(12 months)
  • Lower incisor AP position(12 months)
  • Profile convexity(12 months)
  • Lip protrusion(12 months)
  • Lower incisor inclination(12 months)
  • Upper incisor inclination(12 months)
  • Upper incisor AP position(12 months)

研究者

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

Ahmed Mostafa Zaky

Lecturer of Orthodontics

Ain Shams University

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