Ultrasound
DeviceThe Aevo System™ is an ultrasound emitting dental device.
Other names: Aevo System.
NCT Number: NCT01828164
To study whether or not the Aevo System™ medical device enhances the rate of tooth movement in human subjects who use orthodontic braces.
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Notify Me12 year–40 year
All sexes
Interventional
Not applicable
Site 1: University of Alberta, Facilty of Dentistry, Edmonton, Alberta, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects who meet all of the following criteria will qualify for entry into the study:
Exclusion criteria
Subjects who meet any of the following criteria will be excluded from the study:
The Aevo System™ is an ultrasound emitting dental device.
Other names: Aevo System.
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.
Time frame: 24 weeks or until the extraction space was closed (whichever came first)
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)
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)
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.
SmileSonica Inc.
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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