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临床试验/NCT05440526
NCT05440526已完成2 期

Efficacy of the Mini-plate Anchored Herbst Appliance Versus the Dentally Anchored Fixed Functional Appliance in Young Adult Class II Orthodontic Patients; A Randomized Clinical Trial

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年9月10日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
20
试验地点
2
主要终点
Amount of changes in dentoskeletal cephalometric measurements between Herbst Group and TFBC group

研究概览

简要总结

the objective of the current study is to compare the dentofacial effects of the mini-plate anchored Herbst appliance Versus the dentally anchored Twin force bite corrector Appliance in Young Adult Class II Orthodontic Patients with retruded mandible.

详细描述

Study design:

Prospective randomized clinical study.

Study setting and population:

This study will be conducted on twenty orthodontic patients. The number of patients was dependent on a power study.

Sample size calculation was based on the observed average effect size derived from previous article addressing "the effect of skeletally anchored Forsus FRD using miniplates for the treatment of Class II malocclusion.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 20 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants will be selected based on the following inclusion criteria:
  • Skeletal class 2 malocclusion due to mandibular retrusion with increased overjet (SNA= 82±4, ANB=≥4°).
  • Mandibular arch with minimum (up to 4mm) or no crowding.
  • All permanent teeth are erupted (3rd molar not included).
  • Good oral and general health.
  • No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement.
  • No previous orthodontic treatment.

排除标准

  • Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment.
  • Patients with untreated decay or any endodontic lesions.

结局指标

主要结局

Amount of changes in dentoskeletal cephalometric measurements between Herbst Group and TFBC group

时间窗: one year and four months

lateral cephalometric radiograph was analysed by dolphin software to assess the following angular (in degree) and linear (in mellimeter) measurements : SNA - SNB - ANB - Y AXIS angle - facial angle - (co - A) - (co - gn) - ( upper 1 - SN) - (lower 1 - MP) - overjet - over bite - soft tissue convexity angle.

次要结局

  • Amount of changes in dentoskeletal cephalometric measurements within each group separately(one year and four months)

研究者

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

Mahmoud M. Fathy Aboelmahasen

Clinical professor of orthodontics - Faculty of dental medicine

Al-Azhar University

研究点 (2)

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