To study whether or not the Aevo System™ medical device enhances the rate of tooth movement in human subjects who use orthodontic braces.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
The Aevo System™ is an ultrasound emitting dental device.
Ultrasound not activated in the comparator side of the device.20 minutes per day of ultrasound treatment on the active side of the device. The device consists of a mouth guard type device with transducers embedded in the mouth guard. In the split mouth design, the treatment arm consist of the side of the mouth with the transducers activated while the comparator arm has the transducers deactivated.
Site 3: Strathcona Orthodontics Clinic
Edmonton, Alberta, Canada
Site 1: University of Alberta, Facilty of Dentistry
Edmonton, Alberta, Canada
Site 4: Faculty of Dentistry, University of Manitoba
Winnipeg, Manitoba, Canada
Site 5: Dr. Dumore and Team Orthodontics
Winnipeg, Manitoba, Canada
Rate of Tooth Movement
The weekly rate of tooth movement (mm/week) as compared between the treated side and the control side.
Time frame: 24 weeks or until the extraction space was closed (whichever came first)
Rate of Root Resorption
The weekly rate of tooth root resorption (mm/week) as compared between the treated side and the control side.
Time frame: 24 weeks or until the extraction space was closed (whichever came first)
Discomfort
Average measured level of subject discomfort or pain. The Participant Pain Reporting Scale is used to assess the amount of pain on a 10 point scale. On the 10 point scale, 1 represents the least amount of pain and 10 represents the most amount of pain.
Time frame: 24 weeks or until the extraction space was closed (whichever came first)
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Site 2: Faculty of Dentistry, University of Toronto
Toronto, Ontario, Canada