The Effect of Ultrasound on Orthodontic Tooth Movement

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

Study Overview

• Status: Completed
• Conditions: Malocclusion
• Intervention / Treatment: Device: Ultrasound; Device: Sham comparator

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6E 6E8
      • Site 3: Strathcona Orthodontics Clinic
    • Edmonton, Alberta, Canada, T6G 2E1
      • Site 1: University of Alberta, Facilty of Dentistry
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0W2
      • Site 4: Faculty of Dentistry, University of Manitoba
    • Winnipeg, Manitoba, Canada, R3J 0P1
      • Site 5: Dr. Dumore and Team Orthodontics
  • Ontario
    • Toronto, Ontario, Canada, M5G 1G6
      • Site 2: Faculty of Dentistry, University of Toronto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Ultrasound; The Aevo System™ is an ultrasound emitting dental device.; Other Names: Aevo System.
Sham Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Root Resorption	The weekly rate of tooth root resorption (mm/week) as compared between the treated side and the control side.	24 weeks or until the extraction space was closed (whichever came first)
Discomfort	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.	24 weeks or until the extraction space was closed (whichever came first)

Collaborators and Investigators

• Sponsor: SmileSonica Inc.
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 3, 2013
• First Submitted That Met QC Criteria: April 7, 2013
• First Posted (Estimate): April 10, 2013

Study Record Updates

• Last Update Posted (Actual): May 22, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Tooth; Orthodontics; Braces
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: PR-0018-0031-0041; 197850 (Other Identifier: Health Canada)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED