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临床试验/NCT02456220
NCT02456220已完成不适用

Three-dimensional Assessment of the Dentoskeletal Changes Associated With Herbst Appliance Therapy: A Controlled Clinical Trial

Bernardo Quiroga Souki2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Skeletal mandibular growth after Herbst appliance therapy

研究概览

简要总结

The aim of the study is to perform a three-dimensional (3D) evaluation of the dentoskeletal changes in pubertal Class II malocclusion subjects treated with the Herbst appliance (HAG), in comparison with a Class II comparison group (CG). 3D virtual models generated from three time-point CBCTs (T0, baseline; T1, immediately after Herbst insertion; and T2, 8 months after) of 25 HAG patients will be evaluated. Virtual models obtained from 25 Class II malocclusion patients, in the same stage of biologic maturation and skeletal abnormality, but with no orthopedic treatment will be constructed for the CG subjects. These CG patients are under orthodontic treatment, but only with teeth alignment. Voxel based registration on the anterior cranial fossa will be used to assess maxillary and mandibular displacement/articular fossa remodeling; regional registration on the mandibular corpus will be performed to evaluate mandibular growth and mandibular dental changes; and regional registration on the anterior region of the maxilla will be performed to evaluate maxillary growth and maxillary dental changes.

详细描述

  1. BACKGROUND Class II malocclusion is highly prevalent worldwide, and it is a major reason for orthodontic treatment to be initiated. This type of malocclusion can be restricted to the dentoalveolar region, but the majority of Class II patients exhibit a strong skeletal component to the malocclusion, including most frequently mandibular skeletal retrusion and an increased lower anterior facial height. With increased severity of the mandibular deficiency, the orthodontist is challenged to treat the underlying skeletal problem appropriately.

For growing patients, the use of fixed and removable mandibular advancement appliances has been advocated for many decades. A variety of fixed Herbst appliance designs have achieved worldwide acceptance in that they eliminate most major patient compliance factors. Today the Herbst appliance (HA) is by far the most frequently used mandibular jumping device in the United States, with more Herbst appliance being fabricated than all other functions appliances combined.

The Herbst appliance originally was introduced by Emil Herbst in the early years of the twentieth century, but it did not achieved worldwide clinical acceptance until its re-introduction by Hans Pancherz 70 years later. Since then, a significant number of clinical and scientific studies has been conducted about HA, particularly by Pancherz and colleagues.

Two-dimensional cephalometric studies have reported increases in the length of the mandible and in forward displacement of the mandible following HA in comparison to matched untreated controls. On average, 2 mm of mandibular length gain (measured from Gonion to Pogonion) and 1.5 degree of improvement in the SNB angle can be observed following Herbst appliance therapy.

Investigations in experimental animals have provided the histological evidence of the changes in the condyles, rami, and articular fossae when the mandible is advanced in a laboratory setting. Previous reports have showed an increased proliferation of the condylar cartilage in monkeys that had their mandible advanced with the Herbst appliance. These adaptations occurred primarily in the posterior and posterosuperior regions of the condyle. They also reported significant bone deposition along the posterior border of the mandibular ramus during the early part of the experimental period as well as significant deposition of new bone on the anterior surface of the postglenoid spine at the articular fossae. It should be noted, however, that the post-glenoid spine is not well-defined in humans.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Class II malocclusion with mandibular retrognathism
  • Convex Profile
  • Pubertal period
  • Permanent dentition
  • Parental permission with a signed consent form

排除标准

  • Syndromic patients
  • Previous orthopedic treatment

结局指标

主要结局

Skeletal mandibular growth after Herbst appliance therapy

时间窗: 8 months

To test the mandibular rotation immediately after Herbst appliance insertion; and 2) to compare the displacement of the condyles with the reduction of overjet (OJ) and overbite (OB). Virtual 3D surface models of 25 subjects were generated from the cone-beam computed tomographs taken before treatment, and immediately after Herbst installation. Scans were registered on the cranial bases, and analyzed using point-to-point measurements, color-coded maps and semitransparent overlays.

次要结局

  • Mandibular displacement after Herbst appliance therapy(8 months)
  • Displacement of the mandibular condyles immediately after Herbst appliance insertion - 3D assessment(5 weeks)
  • Maxillary displacement after Herbst appliance therapy(8 months)
  • Bone remodeling of the articular fossae after Herbst appliance therapy(8 months)
  • Dental positional changes after Herbst appliance therapy(8 months)

研究者

发起方
Bernardo Quiroga Souki
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bernardo Quiroga Souki

PhD

Pontifícia Universidade Católica de Minas Gerais

研究点 (2)

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