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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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