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临床试验/NCT05499221
NCT05499221已完成不适用

Segmental Distalization by Bone Anchored Carriere Motion Appliance vs. Conventional One

Mansoura University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年1月26日最近更新:
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
32
试验地点
1
主要终点
Skeletal changes

研究概览

简要总结

Carriere Motion appliance (CMA) was designed to change a Class II molar relationship into a Class I relationship by distalizing the whole posterior maxillary segment by means of class II elastics and mandibular anchorage. To eliminate the adverse effects of CMA with class II elastics, we can use the CMA to distalize the maxillary posterior segment with intra-arch anchorage using infrazygomatic miniscrews. The aim of this study is to evaluate skeletaly anchored CMA for distalization of the maxillary buccal segment vs. conventionally anchored CMA by comparing skeletal and dental measurements obtained from lateral cephalometric radiographs obtained prior to treatment (T0) and immediately after correction of class II and remval of the appliance (T1).

详细描述

Thirty-two class II malocclusion patients with age (11-16) years will be randomly allocated in the two groups:

  1. Conventional anchorage CMA group (CAG): conventional mandibular anchorage using Essix retainer.
  2. Skeletal anchorage CMA group (SAG): anchorage by infra-zygomatic miniscrews. In the CAG, Class II elastics will be attached from the maxillary canine to the mandibular first molar bilaterally with Essix retainer in the lower arch as anchorage means. In the SAG, closing coil spring will be attached from the maxillary canine to the infrazygomatic miniscrews bilaterally. For each patient, two lateral cephalograms will be obtained: one preoperatively and another after completion of distalization. Model measurements will be made using the attached 3Shape computer software.

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)

盲法说明

data will be sent blinded for statistical analysis

入排标准

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

入选标准

  • •Patients age (11-16) years.
  • •Full permanent dentition.
  • •Class II malocclusion with at least an end-on Class II molar relationship bilaterally.

排除标准

  • •Systemic conditions that may interfere with the treatment.
  • •Bad habits that might jeopardize the appliance.
  • •Transverse discrepancy.
  • •Previous orthodontic treatment.

研究组 & 干预措施

Conventional anchorage

Active Comparator

Buccal tubes will be bonded on the lower first molars, an alginate impression will be taken for the lower arch with the buccal tubes in place, and a cast will be poured. A hard vacuum sheet of 1.5- mm thickness will be used to fabricate the Essix appliance. The posterior end of the buccal surface will be trimmed in each lower first molar region, creating a window to allow for attachment of the elastics. Class II elastics will be attached from the maxillary canine to the mandibular first molar bilaterally. During the first month, 1/4-inch heavy elastics will be used. In the following months, 3/16-inch heavy elastics will be used. The patients will be instructed to wear the elastics 24 hours per day, except during mealtimes, and to change them daily.

干预措施: Carriere motion appliance (Device)

Skeletal anchorage

Experimental

Closing coil springs will be attached from the maxillary canine to the infrazygomatic miniscrews bilaterally

干预措施: Carriere motion appliance (Device)

结局指标

主要结局

Skeletal changes

时间窗: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)

degrees

Treatment duration

时间窗: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)

months

Dental changes

时间窗: from date of appliance delivery to date of removal after reaching class I molar relationship (about 4-6 months)

degrees

次要结局

未报告次要终点

研究者

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

Eglal Ahmed

Dr.

Mansoura University

研究点 (1)

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