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The Effect of Ultrasound on Orthodontic Tooth Movement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SmileSonica Inc.
ClinicalTrials.gov Identifier:
NCT01828164
First received: April 3, 2013
Last updated: April 11, 2017
Last verified: April 2017
  Purpose
To study whether or not the Aevo System™ medical device enhances the rate of tooth movement in human subjects who use orthodontic braces.

Condition Intervention
Malocclusion Device: Ultrasound Device: Sham comparator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: The Effect of Ultrasound on Orthodontic Tooth Movement

Resource links provided by NLM:


Further study details as provided by SmileSonica Inc.:

Primary Outcome Measures:
  • Rate of Tooth Movement [ 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.


Secondary Outcome Measures:
  • Rate of Root Resorption [ 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.

  • Discomfort [ 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.


Enrollment: 60
Study Start Date: January 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.
  Eligibility

Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 .
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828164

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

Responsible Party: SmileSonica Inc.
ClinicalTrials.gov Identifier: NCT01828164     History of Changes
Other Study ID Numbers: PR-0018-0031-0041
197850 ( Other Identifier: Health Canada )
Study First Received: April 3, 2013
Results First Received: October 20, 2016
Last Updated: April 11, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by SmileSonica Inc.:
Orthodontics
Braces
Tooth

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 27, 2017