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临床试验/NCT04206267
NCT04206267已完成不适用

The Effectiveness of Vibrational Applications On Orthodontic Treatment: A Randomized-Controlled Clinical Trial

Akdeniz University0 个研究点目标入组 19 人开始时间: 2016年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
主要终点
canine retraction rate

研究概览

简要总结

The aim of this study is to determine whether vibrational applications, as an adjunct to orthodontic forces, increases the rate of tooth movement in patients with fixed orthodontic appliances.

详细描述

Nineteen patients who had class 2 division 1 malocclusion or severe crowding and needed first premolar extractions as a treatment modality were included to the study. The patients were divided into two groups, 8 in control and 11 in the study. The subjects assigned to study group were applied suplementary vibrational forces for 20 min/daily. 3-dimensional digital models were generated just before canine distalization and after space closure by 3Shape TRİOS R700 (3Shape Inc., Copenhagen, Denmark) device. The linear measurements between molars and canines were evaluated. The results were assessed with SPSS 23.0 programme (lBM SPSS Statistics for Windows, NY, USA). The amount of tooth movement for all samples were measured twice by the responsible investigator at one week interval. Interclass correlation coefficient-ICC was used to asses intraobserver accuracy and reliability.Mann- Whitney U test was used to assess treatment effect in terms of time to reach canine distalization. Correlation between measurements were described with Spearman Correlation Coefficient. Interclass correlation was 95%, which is in the range of excellent measurement agreement.

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 (Investigator)

盲法说明

One investigator assigned the patients to study or control group and conducted the linear measurements with 3D Trios System, other investigator treated the samples

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patients who were planned first premolar extractions
  • demonstrated good oral hygiene

排除标准

  • patients with poor oral hygiene and have periodontal problem

结局指标

主要结局

canine retraction rate

时间窗: 6 months

İnitial measurements were conducted after levelling stage and prior to retraction of the canine tooth. Linear measurements were performed between mesial edges of molar tubes and distal edges of canine brackets. Due to using TADs as direct anchorage it is considered that the molars remained constant during the retraction process. After retraction stage, measurements were performed between the mesial edges of the molar tubes and the distal edges of the canine brackets, and the monthly tooth movement rates were detected according to the difference between initial and second measurements.

次要结局

  • the compliance data on device use(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Baris Can Telatar

Principal investigator

Akdeniz University

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