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临床试验/NCT02996292
NCT02996292已完成不适用

Assessment of Dentoalveolar Changes Resulting From Orthodontic Treatment of Crowding With Self-ligating Brackets Using CBCT Randomized Controlled Trial

Damascus University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Speed of alignment

研究概览

简要总结

This experimental study will evaluate the effect of active and passive self-ligating brackets in treatment of crowding, compared with the control group of conventional brackets in class I malocclusion without extraction.

The study sample will consist of 66 patients with 3-6mm crowding. The sample will be allocated randomly into two experimental groups, in addition to a control group.

The brackets will be applied using indirect bonding method for all patients. The dentoalveolar changes occurring after leveling and alignment teeth will be assessed by using CBCT radiographs; pre and post- treatment changes for each group will be evaluated individually.

详细描述

Producing of modern and various brackets systems both self- ligating and conventional make the 3 dimensional important in order to evaluate the root positions and to investigate EARR in multi root teeth, so the research will depend on CBCT to carry out these purposes in our study. Beside to compare the duration of alignment among groups.

Fixed appliances will be applied into three groups as 1. Active self ligating brackets (ASLB), 2. Passive self ligating brackets (PSLB), 3. Conventional brackets (CB) until reach to wire 19*25 S.S upper and lower. During leveling, thermal activated wires will be used in all patients.

CBCT images will be done before and after leveling and alignment of teeth to compare dentoalveolar changes between study groups.

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
14 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • patients permanent dentition stage.
  • crowding up to 6 mm
  • Class I relationship.
  • Good oral hygiene.

排除标准

  • Poor oral hygiene.
  • Previous orthodontic treatment.
  • Patients with syndromes, clefts, or craniofacial abnormalities.
  • Class II or III skeletal anteroposterior relationship.
  • Crowding less than 3mm and more than 6mm.

结局指标

主要结局

Speed of alignment

时间窗: After 9 months

Speed of alignment will be measured and compared between the groups.

次要结局

  • Changes of the torque and tipping of teeth(Evaluation before and after alignment and leveling teeth. (after 9 months))
  • External apical root resorption(After 9 months)
  • Changes of widths and depths of the dental arches(Evaluation before and after alignment and leveling teeth. (after 9 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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