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临床试验/NCT02411812
NCT02411812进行中(未招募)不适用

Effects of the Herbst Appliance With Skeletal Anchorage or Dental Anchorage, and Twin-Block Appliance in Class II Malocclusion: A Randomized Clinical Trial

Klaus Barretto-Lopes2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
2
主要终点
Lower incisors position changes as measured by tomographic superimposition of the mandible.

研究概览

简要总结

The purpose of this study is to determine if the Herbst appliance with indirect skeletal anchorage in mini-implants is capable of preventing excessive inclination of the lower incisors at the end of the treatment when compared to the Herbst appliance with dental anchorage and Twin-Block appliances in patients with Class II malocclusion and overjet ≥ 6 mm.

详细描述

2a. Background

The prevalence of the Angle Class II malocclusion is high, comprising almost half of known orthodontic problems (Silva Filho et al., 1990; Proffit et al., 1998). The Class II malocclusion is frequently responsible for negative aesthetic of the facial profile. This can result in psychosocial problems, principally in the Angle Class II, division I malocclusion because of the pronounced projection of the anterior superior teeth. This projection has also been related to fracture and avulsion of the anterior superior teeth.

Different types of appliances had been developed for the treatment of the Angle Class II malocclusion. Among these, functional orthopedic appliances have been used because they can correct Class II malocclusion with better improvement in the growth of the mandible when compared to headgears, which also can correct the problem, but with better restriction of the growth of the maxilla (Tulloch et al., 1997).

The Herbst appliance is a fixed functional orthopedic appliance that is often used because of its non-compliance-nature and the positive results achieved. Emil Herbst created the Herbst appliance in the 1910s (Pancherz; Ruf, 2008), but it was forgotten for decades. Only in the 1970s, Pancherz began a study of the Herbst appliance, and reported the positive results obtained in treatment of the Class II, division I malocclusion (Pancherz, 1979). Several subsequent studies of the Herbst appliance provided new scientific evidence of its benefits.

Nowadays, the Herbst appliance is often used in the treatment of Class II malocclusions, because of its efficiency (Bremen, Pancherz, 2008) and also because of the positive effects in orthodontic and orthopedic correction (Franchi et al., 1999). However, some investigators have stated that the correction of a Class II malocclusion is a result of anchorage loss, and could be responsible for negative effects on the lower incisors such as protrusion and gingival recession (Pancherz, 1979; Pancherz; Hansen, 1986; Pancherz; Hansen, 1988; Schütz et al., 2002; Vigorito; Yared et al., 2006; Dominguez, 2007).

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
All
接受健康志愿者

入选标准

  • Teenagers aged from 10 to 14 years old (both genders)
  • Parental permission with a signed consent form
  • Referral from the Orthodontics Clinic of the State of Rio de Janeiro University or private clinics
  • Presenting Class II, Division 1 malocclusion with convex profile and minimum overjet of 6 mm in permanent dentition.

排除标准

  • Missing teeth.

结局指标

主要结局

Lower incisors position changes as measured by tomographic superimposition of the mandible.

时间窗: 12 months

Comparison in lower incisors position between the two groups at the end of the treatment.

次要结局

  • Morphological mandible changes as measured by tomographic superimposition of the cranial base.(12 months)
  • Maxilla changes as measured by tomographic superimposition of the cranial base.(12 months)
  • Changes in relationship between maxilla and mandible as measured by tomographic superimposition of the cranial base.(12 months)
  • Lower molar position changes as measured by tomographic superimposition of the mandible.(12 months)
  • Upper molar position changes as measured by tomographic superimposition of the maxilla.(12 months)
  • Facial changes as measured by tomographic superimposition of the face(12 months)
  • Upper airway changes measured by tomographic comparison of spaces of the Nasopharynx (NP), Oropharynx (OP), Hypopharynx (HP) and the end of the Pharynx (P)(12 months)

研究者

发起方
Klaus Barretto-Lopes
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Klaus Barretto-Lopes

Professor in Orthodontics

Rio de Janeiro State University

研究点 (2)

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