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Status:

COMPLETED

The Effect of Ultrasound on Orthodontic Tooth Movement

Lead Sponsor:

SmileSonica Inc.

Conditions:

Malocclusion

Eligibility:

All Genders

12-40 years

Phase:

NA

Brief Summary

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

Detailed 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 ...

Eligibility Criteria

Inclusion

  • Subjects who meet all of the following criteria will qualify for entry into the study:
  • Scheduled to receive orthodontic treatment or in early stage of orthodontic treatment
  • Minimum of 3 mm of extraction space (on both sides of a dental arch) to be closed either by distal movement of all 6 anterior teeth from canine to canine or by distal movement of the canines.
  • Available for follow-up visits.
  • Willing and able to sign written informed consent.
  • Healthy.
  • Has permanent dentition and between the ages of 12 and 40.
  • Good oral hygiene and compliance

Exclusion

  • Subjects who meet any of the following criteria will be excluded from the study:
  • Any compromised medical or dental condition that prevents the subject from participating in the trial or using the medical device.
  • Any implanted assistive devices.
  • Currently involved in any other study.
  • Lives significantly outside the clinical trial site.
  • Use of bisphosphonates.
  • Pregnant females .

Key Trial Info

Start Date :

January 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2015

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT01828164

Start Date

January 1 2013

End Date

July 1 2015

Last Update

May 22 2017

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Site 3: Strathcona Orthodontics Clinic

Edmonton, Alberta, Canada, T6E 6E8

2

Site 1: University of Alberta, Facilty of Dentistry

Edmonton, Alberta, Canada, T6G 2E1

3

Site 4: Faculty of Dentistry, University of Manitoba

Winnipeg, Manitoba, Canada, R3E 0W2

4

Site 5: Dr. Dumore and Team Orthodontics

Winnipeg, Manitoba, Canada, R3J 0P1