跳至主要内容
临床试验/NCT02080338
NCT02080338已完成不适用

Is the 0.018-inch or the 0.022-inch Bracket Slot System More Effective in Orthodontic Treatment? A Randomized Clinical Trial.

David Bearn3 个研究点 分布在 1 个国家目标入组 187 人开始时间: 2010年1月1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
发起方
入组人数
187
试验地点
3
主要终点
Duration of fixed appliance orthodontic treatment

研究概览

简要总结

The purpose of this study is to compare the 0.018-inch and 0.022-inch bracket slot systems to determine which is more effective for orthodontic treatment .

详细描述

Background: Edgewise fixed orthodontic appliances are available in two different brackets slot sizes (0.018-inch and 0.022-inch). Both systems are used by clinicians worldwide with many orthodontists claiming clinical advantages and superiority of one system over the other. However, the scientific evidence supporting this area is scarce and weak. This leaves the clinician's choice of bracket slot system to be based mainly on empirical clinical preferences.

Aim: To compare the 0.018-inch and 0.022-inch conventional ligation pre-adjusted orthodontic bracket slot systems in terms of the effectiveness of treatment.

Methods/Design: Prospective, multi-centre randomised clinical trial, undertaken in the secondary care hospital environment in NHS (National Health Service) Tayside in the United Kingdom. Two hundred and sixteen orthodontic patients will be recruited in three secondary care centres in NHS Tayside, United Kingdom. The participants will be randomly allocated to treatment with either the 0.018-inch or 0.022-inch bracket slot systems (n= 108 for each group) using Victory conventional ligation pre-adjusted bracket systems (3M Unitek, Monrovia, California). Baseline records and outcome data will be collected both during and at the end of orthodontic treatment and will be assessed as follows:. Primary outcome measures: The duration of orthodontic treatment for the maxillary and mandibular arches. Secondary outcome measures: The number of scheduled appointments for the maxillary and mandibular arches, occlusal outcome (Peer Assessment Rating index), orthodontically induced inflammatory root resorption using periapical radiographs and the patient perception of wearing orthodontic appliances.

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
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients scheduled to undergo dual arch fixed appliance orthodontic treatment in any of the three trial centers will be invited to participate in this trial by the operator planning to conduct their orthodontic treatment.

排除标准

  • •Patients who have undergone previous orthodontic treatment including fixed, removable and functional appliances.
  • •Patients less than 12 years old at the start of orthodontic treatment.
  • •Patients with orofacial clefting, severe hypodontia, and special needs patients.
  • •Patients undergoing orthognathic (jaw) surgery as part of their orthodontic treatment plan.

研究组 & 干预措施

0.018 bracket slot system

Experimental

Participants treated using 0.018-inch orthodontic bracket slot system

干预措施: Orthodontic bracket slot system (Device)

0.022 bracket slot system

Active Comparator

Participants treated using 0.022-inch orthodontic bracket slot system

干预措施: Orthodontic bracket slot system (Device)

结局指标

主要结局

Duration of fixed appliance orthodontic treatment

时间窗: Completion of orthodontic treatment, an expected average of 24 months.

Number of months in orthodontic treatment from the start of fitting the fixed orthodontic appliance until the removal of the fixed appliance.

次要结局

  • Occlusal treatment outcome(The ooclusal outcome will be assessed at the end of orthodontic treatment, an average of 24 months.)

研究者

发起方
David Bearn
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Bearn

Professor of Orthodontics

University of Dundee

研究点 (3)

Loading locations...

相似试验