The Effect of Ultrasound on Orthodontic Tooth Movement

Malocclusion Clinical Trial

Official title:

The Effect of Ultrasound on Orthodontic Tooth Movement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01828164
• Other study ID #: PR-0018-0031
• Secondary ID: 197850
• Status: Recruiting
• Phase: Phase 3
• First received: April 3, 2013
• Last updated: May 21, 2015
• Start date: January 2013
• Est. completion date: July 2015

Study information

• Verified date: May 2015
• Source: SmileSonica Inc.
• Contact: Cristian Scurtescu, MS
• Phone: 780-641-1964
• Email: cristian.scurtescu[@]smilesonica.com
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• Ultrasound
The Aevo System™ is an ultrasound emitting dental 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.

Locations

Country	Name	City	State
Canada	University of Alberta Department of Dentistry	Edmonton	Alberta
Canada	Faculty of Dentistry, University of Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
SmileSonica Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of tooth movement.	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.	6 Months.	No
Secondary	Root length.	Tooth root length as compared in small-field-of-view CBCTs taken at week 0 and week 24.	6 months.	No
Secondary	Discomfort	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.	6 Months	No