The Effect of Ultrasound on Orthodontic Tooth Movement
To study whether or not the Aevo System™ medical device enhances the rate of tooth movement in human subjects who use orthodontic braces.
|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
|Official Title:||The Effect of Ultrasound on Orthodontic Tooth Movement|
- Rate of tooth movement. [ Time Frame: 6 Months. ] [ Designated as safety issue: No ]
The difference in the average monthly (28 day) rate of tooth movement in the treated side as compared to control side of device will be measured. The time to close a minimum 3mm extraction space over the treatment period will be recorded. Small-field-of-view CBCTs of maxillary and mandibular teeth are taken on the canines to assess the canines' root length. The resolution used will be 0.25mm @ 26.9 sec.
Base-line full dental arch impressions will be taken every 4 weeks, and the dental casts will be produced for measuring tooth position.
- Root length. [ Time Frame: 6 months. ] [ Designated as safety issue: No ]Tooth root length as compared in small-field-of-view CBCTs taken at week 0 and week 24.
- Discomfort [ Time Frame: 6 Months ] [ Designated as safety issue: No ]Measured level of subject discomfort or pain. The Participant Pain Reporting Scale is used to assess the source, location and amount of pain on a 10 point scale.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment Arm
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.
The Aevo System™ is an ultrasound emitting dental device.
Other Name: Aevo System.
Sham Comparator: Control Arm
The transducers are not activated on the control side of the device.The subjects wear the device for 20 minutes per day for the duration of the study. The device consists of a mouth guard type device with transducers embedded in the mouth guard. In the split mouth design, the control arm consist of the side of the mouth with the transducers deactivated.
Device: Sham comparator
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01828164
|Contact: Cristian Scurtescu, MSfirstname.lastname@example.org|
|Contact: John Simon, BS||780-975-0095||John@JohnSimon.ca|
|University of Alberta Department of Dentistry||Recruiting|
|Edmonton, Alberta, Canada, T6G 2N8|
|Contact: Tarek El-Bialy, PhD 780-492-2751 email@example.com|
|Principal Investigator: Tarek El-Bialy, PhD, FRCD(C)|
|Faculty of Dentistry, University of Toronto||Recruiting|
|Toronto, Ontario, Canada, M5G 1G6|
|Contact: Kevin L Knowlton, DDS Kevin.Knowlton@utoronto.ca|
|Principal Investigator: Kevin L Knowlton, DDS|
|Principal Investigator:||Tarek El-Bialy, PhD||University of Alberta Department of Dentistry|
|Principal Investigator:||Kevin L Knowlton, DDS||Faculty of Dentistry, University of Toronto|
|Principal Investigator:||Bryan D Tompson, DDS, FRCD(C)||Faculty of Dentistry, University of Toronto|