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临床试验/NCT06955637
NCT06955637已完成不适用

Comparison Between Removable Devices in Overjet Reduction: a Randomised Open Label Clinical Trial

University of L'Aquila2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年12月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Changes in the horizontal distance between the upper and lower incisors

研究概览

简要总结

The goal of this clinical trial si to compare two removable devices used to treat the mandibular retrusion in growing patients.

The main questions it aims to answer are:

  • the efficacy of the two devices in the reduction of the overjet
  • the neuromuscolar effects developed on the stomatognatic system Participants will be instructed in the use and maintenance of the devices and will be checked every 15-30 days for one year.

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
9 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • skeletal class II relationship,
  • complete eruption of upper first premolars
  • presence of unilateral or bilateral cross bite (falling within grade 3 IOTN index).

排除标准

  • IOTN (INDEX OF ORTHODONTIC TREATMENT NEED) index > 4;
  • presence of epilepsy,
  • systemic disease,
  • TMD, or periodontal disease;
  • lack of written informed consent from a parent or legal guardian.

结局指标

主要结局

Changes in the horizontal distance between the upper and lower incisors

时间窗: 12 months

To evaluate the possible reduction of the horizontal distance between the incisors of the two dental arches at two specific times

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

Eleonora Ortu

Researcher

University of L'Aquila

研究点 (2)

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