跳至主要内容
临床试验/NCT04911400
NCT04911400进行中(未招募)不适用

Effects of Class III Elastics on Stability of Orthopaedic Class III Correction

Sydney Local Health District4 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2020年7月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
42
试验地点
4
主要终点
Difference in overjet of participants in the 2 study arms

研究概览

简要总结

The purpose of this study is to evaluate the effects of adding elastics to orthodontic retainers on the stability of class III correction and whether it reduces the need for jaw surgery.

详细描述

Over the years many types of appliances have been recommended for retaining Class III correction in growing children such as intermaxillary splints, class III activator, Frankel 3, Class III twin block, continued use of face-mask and chin-cup. However, currently none of these are in routine use and there is no evidence on the long term effectiveness of any retention protocol for class III correction.

One of the most commonly used retainers following orthodontic treatment is clear plastic retainers. There are no studies that investigated whether using class III elastics in combination with clear plastic retainers improves the stability of class III correction and reduces the need for later jaw surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Patients that completed their orthodontic treatment for the management of their skeletal class III with upper jaw retrusion that was treated with Class III orthopaedic appliances, followed by full fixed appliances.
  • No congenital anomalies or craniofacial syndromes
  • No other orthodontic treatment
  • No medical history that effects growth

排除标准

  • Congenital anomalies or craniofacial syndromes
  • Other orthodontic treatment
  • Medical history that effects growth

研究组 & 干预措施

Upper-lower clear plastic retainers + Class III elastics

Experimental

Upper-lower clear plastic retainers + Class III elastics

干预措施: Upper-lower clear plastic retainers + Class III elastics (Other)

Upper-lower clear plastic retainers

Active Comparator

Upper-lower clear plastic retainers

干预措施: Upper-lower clear plastic retainers (Other)

结局指标

主要结局

Difference in overjet of participants in the 2 study arms

时间窗: 5 years

Measurement of overjet

次要结局

  • Difference in upper jaw position(5 years)
  • Difference in upper-lower jaw relationship(5 years)
  • Difference in upper incisor angulation(5 years)
  • Periodontal health, including recession around the incisors(5 years)
  • Need for jaw surgery(5 years)
  • Difference in lower jaw position(5 years)
  • Difference in lower incisor angulation(5 years)
  • Compliance and ease of use of both retention regimens(5 years)
  • Effect of elastics on alignment retention(5 years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验