NCT01828164

The Effect of Ultrasound on Orthodontic Tooth Movement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: SmileSonica Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Malocclusion

Interventions

Type	Name	Description
DEVICE	Ultrasound	The Aevo System™ is an ultrasound emitting dental device.
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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2013-04-10
• Last updated: 2017-05-22
• Results posted: 2017-04-12

Locations

5 sites across 1 country: Canada