跳至主要内容
临床试验/NCT06253286
NCT06253286已完成不适用

Predictability of Part-time Wearing of Removable Clear Aligner Therapy Versus Full Time

Future University in Egypt1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年11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
入组人数
14
试验地点
1
主要终点
Linear Movement Discrepancies Between Digital Software Models and Clinical Models

研究概览

简要总结

14 Patients with mild to moderate crowding and spacing will be selected according to inclusion criteria.

Treatment planning will be done on Maestro® software. An impression will be taken and scanned by an extra-oral scanner. The models will be 3D printed and aligner trays will be fabricated to be delivered on biweekly basis to be worn 16 hours per day for one group and 22 hours for the other group. Superimposition of the achieved clinical model over the predicted model will be done. Linear and angular measurements will be calculated for each tooth.

详细描述

Clear removable retainers could be related to clear aligners. Wearing time of retainers has been suggested that it could be changed from full time to part-time during the night only. A similar approach could be done to determine the effect of wearing time of clear aligners on treatment outcome. The standard duration per day for wearing the appliance is 22 hours. However, is part-time wearing (16 hours) would have the same effect? Therefore, a randomized clinical trial is needed to compare the effect of partial wearing of the aligner versus full time. Moreover, studying the predictability and accuracy of treatment using Maestro software.

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
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •Permeant dentition
  • •Mild to moderate crowding and spacing in maxilla and mandible according to Little's Irregularity Index
  • •Non-extraction cases

排除标准

  • •Severe crowding and spacing
  • •Systematic diseases
  • •Compromised periodontal health
  • •Craniofacial syndromes

研究组 & 干预措施

part-time wear

Active Comparator

Patients will be instructed to wear the aligner for 16 hours per day, then the aligner going to be changed to the next step according to its numerical order in the software

干预措施: clear aligner treatment for orthodontics patients (Device)

Full-time wear

Active Comparator

Patients will be instructed to wear the aligner for 22 hours per day, then the aligner going to be changed to the next step according to its numerical order in the software

干预措施: clear aligner treatment for orthodontics patients (Device)

结局指标

主要结局

Linear Movement Discrepancies Between Digital Software Models and Clinical Models

时间窗: an average of 1 year

Translation movements (mm) were compared for each tooth between predicted models on Software predicted models and actual clinical models for the study groups

Angular Movement Discrepancies Between Digital Software Models and Clinical Models

时间窗: an average of 1 year

Translation movements (Degrees) were compared for each tooth between predicted models on Software predicted models and actual clinical models for the study groups

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

Mohamed Adel Zein

Principle Investigator

Future University in Egypt

研究点 (1)

Loading locations...

相似试验