Clinical trial NCT01828164: The Effect of Ultrasound on Orthodontic Tooth Movement
Official title: The Effect of Ultrasound on Orthodontic Tooth Movement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: Orthodontics
Braces
Tooth
Lead sponsor: SmileSonica Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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 .

Primary outcomes:
measure: Rate of Tooth Movement
timeFrame: 24 weeks or until the extraction space was closed (whichever came first)
Secondary outcomes:
measure: Rate of Root Resorption
timeFrame: 24 weeks or until the extraction space was closed (whichever came first)
measure: Discomfort
timeFrame: 24 weeks or until the extraction space was closed (whichever came first)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Site 3: Strathcona Orthodontics Clinic
state: Alberta
city: Edmonton
country: Canada
facility: Site 1: University of Alberta, Facilty of Dentistry
state: Alberta
city: Winnipeg
country: Canada
facility: Site 4: Faculty of Dentistry, University of Manitoba
state: Manitoba
city: Winnipeg
country: Canada
facility: Site 5: Dr. Dumore and Team Orthodontics
state: Manitoba
city: Toronto
country: Canada
facility: Site 2: Faculty of Dentistry, University of Toronto
state: Ontario
Study officials:
affiliation: University of Alberta, Department of Dentistry
name: Tarek El-Bialy, PhD, FRCD(C)
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, University of Toronto
name: Kevin L Knowlton, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, University of Toronto
name: Bryan D Tompson, DDS, FRCD(C)
role: PRINCIPAL_INVESTIGATOR
affiliation: Strathcona Orthodontics, Edmonton
name: Terry Carlyle, DDS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, University of Manitoba
name: William Wiltshire, BChD, ChD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Dumore and Team Orthodontics, Winnipeg
name: Tim Dumore, DMD, BS, MS
role: PRINCIPAL_INVESTIGATOR
References: