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临床试验/NCT02951286
NCT02951286已完成不适用

Skeletal and Dentoalveolar Changes Following Posterior Teeth Intrusion With High Pull Headgear in The Treatment of Patients With Anterior Open Bite

Damascus University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2016年2月最近更新:
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
24
试验地点
2
主要终点
Overbite

研究概览

简要总结

This prospective clinical study will evaluate the effect of high pull headgear for molar intrusion, compared with the control group, in adolescent patients with open bite malocclusion.

The study sample will consist of 24 patients with anterior open bite divided equally in two groups. The sample will be collected consecutively from patients attending the Orthodontic Department at Damascus university.

A modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied for all patients. High pull headgears will be used in the first group, while, in the second (control) group, Open Bite Appliances will be used only.

The skeletal and dentoalveolar changes occurring after intrusion of posterior teeth will be assessed by using posteroanterior and lateral cephalometric radiographs; pre- and post- treatment changes for each group will be evaluated.

详细描述

Open bite malocclusion is considered one of the most difficult malocclusion to correct in orthodontic treatment because it appears as a result of different etiological factors such as genetic, dental, skeletal, functional, soft tissue, and habits that play roles in its development. Different treatment modalities used for the treatment of an anterior open bite. Multiloop edgewise archwires, miniscrews, high-pull headgear, and bite blocks have been used for anterior open bite patients, most open bite patients characterized by increased facial height, class II skeletal pattern, and vertical excess in maxillary posterior teeth.

Functional appliances, magnets, posterior bite blocks, and high pull headgear are used for posterior teeth intrusion. It is possible to generate intrusive force by using high pull headgear. Furthermore, direction of force can be changed according to the center of resistance of the dental units to achieve a better tooth movement control. The intrusion of posterior teeth will lead to decreased lower facial height by a counterclockwise rotation of the mandible; and improve class II skeletal relationship.

This study was the first clinical trial, that compare the effect of high pull headgear for molar intrusion with the control group in adolescent patients.

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
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with skeletal open bite determined by an increased B angle (angle between maxillary plane and mandibular plane), sum of Bjork and the mandibular plane angle (angle between SN plane and mandibular plane).
  • patients between 12 and 18 years old with permanent dentition stage.
  • Negative over bite of more than a mm
  • Class I and Class II skeletal anteroposterior relationship.

排除标准

  • Previous orthodontic treatment.
  • Patients with syndromes, clefts, or craniofacial abnormalities.
  • Class III skeletal anteroposterior relationship.

研究组 & 干预措施

high pull headgear + OBA

Experimental

A modified version of the Open Bite Appliance (OBA),introduced by Erverdi and Usumez, will be applied with high pull headgear for Orthoclassic ®1300 NE Alpha Drive, McMinnville, OR 97128 USA 866.752.0065.

干预措施: high pull headgear + OBA (Device)

OBA (control group)

Experimental

A modified version of the Open Bite Appliance (OBA),introduced by Erverdi and Usumez, will be applied only.

干预措施: OBA (control group) (Device)

结局指标

主要结局

Overbite

时间窗: This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be abroximately after 7 months.

The distance between the incisal edges of the upper and lower incisors, measured in mm.

次要结局

  • Molar intrusion(This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months)
  • Anterior facial height(This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months)
  • Mandibular autorotation(This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months)
  • Change in the anteroposterior position of the point "B"(This variable will be evaluated twice; T0 before treatment, and T1 at the end of molar intrusion which will be approximately after 7 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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