The Effect of Ultrasound on Orthodontic Tooth Movement

SmileSonica

Status: Completed

Conditions: Malocclusion

Treatments: Device: Sham comparator; Device: Ultrasound

Study type: Interventional

Funder types: Industry

Identifiers

NCT01828164

197850 (Other Identifier)

PR-0018-0031-0041

Details and patient eligibility

About

To study whether or not the Aevo System™ medical device enhances the rate of tooth movement in human subjects who use orthodontic braces.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Subjects who meet all of the following criteria will qualify for entry into the study:

1. Scheduled to receive orthodontic treatment or in early stage of orthodontic treatment
2. 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.
3. Available for follow-up visits.
4. Willing and able to sign written informed consent.
5. Healthy.
6. Has permanent dentition and between the ages of 12 and 40.
7. Good oral hygiene and compliance

Exclusion criteria

Subjects who meet any of the following criteria will be excluded from the study:

1. Any compromised medical or dental condition that prevents the subject from participating in the trial or using the medical device.
2. Any implanted assistive devices.
3. Currently involved in any other study.
4. Lives significantly outside the clinical trial site.
5. Use of bisphosphonates.
6. Pregnant females .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

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.

Treatment:

Device: Ultrasound

Control Arm

Sham Comparator group

Description:

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.

Treatment:

Device: Sham comparator