The Effect of Ultrasound on Orthodontic Tooth Movement

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by SmileSonica Inc.
Sponsor:
Information provided by (Responsible Party):
SmileSonica Inc.
ClinicalTrials.gov Identifier:
NCT01828164
First received: April 3, 2013
Last updated: July 22, 2013
Last verified: July 2013
  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 Phase
Malocclusion
Device: Ultrasound
Device: Sham comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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: 6 Months. ] [ Designated as safety issue: No ]

    The difference in the average monthly (28 day) rate of tooth movement in the treated side as compared to control side of device will be measured. The time to close a minimum 3mm extraction space over the treatment period will be recorded. Small-field-of-view CBCTs of maxillary and mandibular teeth are taken on the canines to assess the canines' root length. The resolution used will be 0.25mm @ 26.9 sec.

    Base-line full dental arch impressions will be taken every 4 weeks, and the dental casts will be produced for measuring tooth position.



Secondary Outcome Measures:
  • Root length. [ Time Frame: 6 months. ] [ Designated as safety issue: No ]
    Tooth root length as compared in small-field-of-view CBCTs taken at week 0 and week 24.

  • Discomfort [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Measured level of subject discomfort or pain. The Participant Pain Reporting Scale is used to assess the source, location and amount of pain on a 10 point scale.


Estimated Enrollment: 25
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Cristian Scurtescu, MS 780-641-1964 cristian.scurtescu@smilesonica.com
Contact: John Simon, BS 780-975-0095 John@JohnSimon.ca

Locations
Canada, Alberta
University of Alberta Department of Dentistry Recruiting
Edmonton, Alberta, Canada, T6G 2N8
Contact: Tarek El-Bialy, PhD    780-492-2751    telbialy@ualberta.ca   
Principal Investigator: Tarek El-Bialy, PhD, FRCD(C)         
Canada, Ontario
Faculty of Dentistry, University of Toronto Recruiting
Toronto, Ontario, Canada, M5G 1G6
Contact: Kevin L Knowlton, DDS       Kevin.Knowlton@utoronto.ca   
Principal Investigator: Kevin L Knowlton, DDS         
Sponsors and Collaborators
SmileSonica Inc.
Investigators
Principal Investigator: Tarek El-Bialy, PhD 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
  More Information

No publications provided

Responsible Party: SmileSonica Inc.
ClinicalTrials.gov Identifier: NCT01828164     History of Changes
Other Study ID Numbers: PR-0018-0031, 197850
Study First Received: April 3, 2013
Last Updated: July 22, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by SmileSonica Inc.:
Orthodontics
Braces
Tooth

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 19, 2014