The Effect of Ultrasound on Orthodontic Tooth Movement

NCT01828164 | Completed Results

• 2 other identifiers: PR-0018-0031-0041197850
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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.

Conditions

Malocclusion

Keywords

Orthodontics; Braces; Tooth

Outcome Measures

Primary Outcomes (1)

• Rate of Tooth Movement

  The weekly rate of tooth movement (mm/week) as compared between the treated side and the control side.

  24 weeks or until the extraction space was closed (whichever came first)

Secondary Outcomes (2)

• Rate of Root Resorption

  24 weeks or until the extraction space was closed (whichever came first)

• Discomfort

  24 weeks or until the extraction space was closed (whichever came first)

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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.

Device: Ultrasound

Control Arm

SHAM COMPARATOR

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

Interventions

Ultrasound DEVICE

The Aevo System™ is an ultrasound emitting dental device.

Also known as: Aevo System.

Treatment Arm

Sham comparator 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.

Control Arm

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects who meet all of the following criteria will qualify for entry into the study:
• Scheduled to receive orthodontic treatment or in early stage of orthodontic treatment
• 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.
• Available for follow-up visits.
• Willing and able to sign written informed consent.
• Healthy.
• Has permanent dentition and between the ages of 12 and 40.
• Good oral hygiene and compliance

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from the study:
• Any compromised medical or dental condition that prevents the subject from participating in the trial or using the medical device.
• Any implanted assistive devices.
• Currently involved in any other study.
• Lives significantly outside the clinical trial site.
• Use of bisphosphonates.
• Pregnant females .

Sponsors & Collaborators

• SmileSonica Inc.: lead

Study Sites (5)

Site 3: Strathcona Orthodontics Clinic

Edmonton, Alberta, T6E 6E8, Canada

Location

Site 1: University of Alberta, Facilty of Dentistry

Edmonton, Alberta, T6G 2E1, Canada

Location

Site 4: Faculty of Dentistry, University of Manitoba

Winnipeg, Manitoba, R3E 0W2, Canada

Location

Site 5: Dr. Dumore and Team Orthodontics

Winnipeg, Manitoba, R3J 0P1, Canada

Location

Site 2: Faculty of Dentistry, University of Toronto

Toronto, Ontario, M5G 1G6, Canada

Location

MeSH Terms

Conditions

Malocclusion

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: John Simon, Regulatory Affairs Manager
• Organization: SmileSonica Inc.

john@johnsimon.ca

780-975-0095

Study Officials

• Tarek El-Bialy, PhD, FRCD(C)

  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

  PRINCIPAL INVESTIGATOR

• Terry Carlyle, DDS, MS

  Strathcona Orthodontics, Edmonton

  PRINCIPAL INVESTIGATOR

• William Wiltshire, BChD, ChD

  Faculty of Dentistry, University of Manitoba

  PRINCIPAL INVESTIGATOR

• Tim Dumore, DMD, BS, MS

  Dr. Dumore and Team Orthodontics, Winnipeg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 10, 2013
• Study Start: January 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 22, 2017
• Results First Posted: April 12, 2017

Record last verified: 2017-04

Locations

CA (5)