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临床试验/NCT04518865
NCT04518865已完成不适用

Treatment Effects of Herbst Appliance in Skeletal Class II Cases During Prepubertal and Postpubertal Periods: A Cone Beam Computed Tomographic Study

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Skeletal and dental changes

研究概览

简要总结

The study was directed to compare the treatment outcomes of subjects with Class II malocclusion who were treated with Herbst appliance before and after puberty.

详细描述

Thirty-six Class II patients were randomly selected and divided into two groups based on their stage of skeletal maturation: pre-pubertal group (18 patients, mean age 9.15± 1.5 years) and post-pubertal group (18 patients, mean age 16.3 ± 1.0 years). All patients were treated with metallic splint supported Herbst IV appliance.

Pretreatment and post-Herbst IV treatment cone beam CT(CBCT) scans were obtained for both groups. Dentoskeletal and TMJ measurements made on the CBCT scans were analysed.

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
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Skeletal Class II malocclusion with retrognathic mandible (ANB >5°, SNB<76°)
  • Normal growth pattern (SN/MP angle was in 25°- 35° range)
  • Unilateral or bilateral Class II molar relationship greater than or equal to one-half a cusp width.
  • Minimal or no crowding in the mandibular arch (0-5mm).
  • Average inclination or slight retroclination of the lower incisor.
  • An overjet greater than 5 mm.

排除标准

  • Skletal Class I
  • Craniofacial syndrome.

结局指标

主要结局

Skeletal and dental changes

时间窗: 8 months

The DICOM (Digital Imaging and Communications in Medicine) files from the pre and post CBCT scans were imported to Mimics software (Version 10.1, Materialise NV, Leuven, Belgium); and the cephalometric landmarks and planes were defined . Linear sagittal measurements of point A, point B, glenoid fossa, upper incisor, lower incisor, upper molars, and lower molars were recorded in relation to orbital perpendicular plane.

次要结局

  • Condylar head position(8 months)

研究者

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

khaled farouk

lecturer

Al-Azhar University

研究点 (1)

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