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OpenTrials
Completed

NCT Number: NCT04206267

The Effectiveness of Vibrational Applications on Orthodontic Treatment

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.

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patients with poor oral hygiene and have periodontal problem

Treatment and study plan

Acceledent

Device

Device for accelerating tooth movement

Primary outcomes

  1. canine retraction rate

    Time frame: 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.

Secondary outcomes

  1. the compliance data on device use

    Time frame: 6 months

    it was collected by downloading the tracking information on the device

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 20, 2019
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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