The Effect of Ultrasound on Orthodontic Tooth Movement

NCT ID: NCT01828164

Last Updated: 2017-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: DEVICE

The Aevo System™ is an ultrasound emitting dental device.

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.

Group Type: SHAM_COMPARATOR

Sham comparator

Intervention Type: 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.

Interventions

Ultrasound

The Aevo System™ is an ultrasound emitting dental device.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Aevo System.

Eligibility Criteria

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 .

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SmileSonica Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tarek El-Bialy, PhD, FRCD(C)

Role: PRINCIPAL_INVESTIGATOR

University of Alberta, Department of Dentistry

Kevin L Knowlton, DDS

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, University of Toronto

Bryan D Tompson, DDS, FRCD(C)

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, University of Toronto

Terry Carlyle, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

Strathcona Orthodontics, Edmonton

William Wiltshire, BChD, ChD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, University of Manitoba

Tim Dumore, DMD, BS, MS

Role: PRINCIPAL_INVESTIGATOR

Dr. Dumore and Team Orthodontics, Winnipeg

Locations

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

Site 2: Faculty of Dentistry, University of Toronto

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

197850

Identifier Type: OTHER

Identifier Source: secondary_id

PR-0018-0031-0041

Identifier Type: -

Identifier Source: org_study_id