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临床试验/NCT03683862
NCT03683862已完成不适用

Objective Evaluation of Compliance After Orthodontic Treatment Using Thermoplastic or Hawley Retainers: A Randomized Controlled Trial

University of Athens2 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2018年1月3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
77
试验地点
2
主要终点
Compliance of retainer wear

研究概览

简要总结

This study aims to assess adolescent's compliance after the end of orthodontic treatment using either thermoplastic or Hawley retainers in the upper arch, with the aid of TheraMon microsensor (MC Technology GmbH).

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
None

入排标准

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

入选标准

  • patients that have completed orthodontic treatment (are at stage of debonding) with fixed appliances in the upper and lower arch
  • age 12- 18

排除标准

  • systematic diseases
  • craniofacial anomalies (clefts, etc)
  • handicapped patients with problems of compliance
  • pregnant women
  • previous orthodontic treatment or compromise orthodontic treatment

研究组 & 干预措施

Thermoplastic Retainer

Experimental

Impressions of the upper arch will be taken at the day of bracket debonding and the retainer will be delivered in 24 hours. TheraMon microchip will be embedded within the appliance and patients will be instructed to wear the appliance 24 hours/ day.

干预措施: orthodontic appliance (Other)

Hawley Retainer

Active Comparator

Impressions of the upper arch will be taken at the day of bracket debonding and the retainer will be delivered in 24 hours. TheraMon microchip will be embedded within the appliance and patients will be instructed to wear the appliance 24 hours/ day.

干预措施: orthodontic appliance (Other)

结局指标

主要结局

Compliance of retainer wear

时间窗: 3 months

Compliance of retainer wear at 3 months, as expressed by average hours of daily wear (with the aid of TheraMon)

次要结局

  • Compliance of retainer wear(1 month)
  • Association between objective compliance assessment and diary reported hours(1 month)

研究者

发起方
University of Athens
申办方类型
Other
责任方
Principal Investigator
主要研究者

Despina Koletsi

Researcher

University of Athens

研究点 (2)

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