The Effect of Ultrasound on Orthodontic Tooth Movement

Status Recruiting

Clinical Trial Summary

To study whether or not the Aevo System™ medical device enhances the rate of tooth movement in human subjects who use orthodontic braces.

Clinical Trial Description

The study will involve comparing the effects of tooth movement with and without ultrasound treatment in a split mouth design. Treatment will consist of using the Aevo System™ device for one 20 minute period per day for the duration of the trial (up to 24 weeks). Tooth position measurements will be taken from eligible patients prior to commencing usage of the study device. Follow-up visits will be scheduled for intra-oral clinical measurements and to take full-arch impressions. The Aevo System™ consists of an ultrasound emitting mouthpiece which is wire connected to an external handheld device. The mouthpiece is placed over the teeth and over the braces every day for 20 minutes in order to deliver the therapy. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Malocclusion

Clinical Trial Details

NCT number	NCT01828164
Study type	Interventional
Source	SmileSonica Inc.
Contact	Cristian Scurtescu, MS
Phone	780-641-1964
Email	cristian.scurtescu@smilesonica.com
Status	Recruiting
Phase	Phase 3
Start date	January 2013
Completion date	July 2015

View Details

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