MalocclusionNCT01828164

The Effect of Ultrasound on Orthodontic Tooth Movement

A study testing Ultrasound in people with Malocclusion, run by SmileSonica Inc. at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 12 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Malocclusion
What is being tested?: Ultrasound
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 5 sitesCanada
Study dates: Jan 2013to Jul 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 40 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Subjects who meet all of the following criteria will qualify for entry into the study:
Scheduled to receive orthodontic treatment or in early stage of orthodontic treatment
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.
Available for follow-up visits.
Willing and able to sign written informed consent.
Healthy.
Has permanent dentition and between the ages of 12 and 40.
Good oral hygiene and compliance

Who cannot join

Subjects who meet any of the following criteria will be excluded from the study:
Any compromised medical or dental condition that prevents the subject from participating in the trial or using the medical device.
Any implanted assistive devices.
Currently involved in any other study.
Lives significantly outside the clinical trial site.
Use of bisphosphonates.
Pregnant females .

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Canada5 sites

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

Other trials in Canada

About this study

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

Read the 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.

Conditions: Malocclusion
Being tested: Ultrasound, Sham comparator
Keywords: Orthodontics, Braces, Tooth
Medical subject headings: Malocclusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UltrasoundDevice
Also called Aevo System.
The Aevo System™ is an ultrasound emitting dental device.
Sham comparatorDevice
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.

Study groups in NCT01828164
Study group	Role	What they receive
Treatment Arm	Experimental	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. Receives: Device: Ultrasound
Control Arm	Sham comparator	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. Receives: Device: Sham comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Tooth Movement
The weekly rate of tooth movement (mm/week) as compared between the treated side and the control side.
Measured: 24 weeks or until the extraction space was closed (whichever came first)

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Jul 2015

First posted10 Apr 2013 (estimated)
Study startJan 2013
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MalocclusionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01828164
Sponsor's protocol ID: PR-0018-0031-0041
Other IDs: 197850
Status last verified: Apr 2017
First submitted: 3 Apr 2013
Last updated: 22 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children

All Malocclusion trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Ultrasound on Orthodontic Tooth Movement
ClinicalTrials.gov ID: NCT01828164
Acronym / sponsor ID: PR-0018-0031-0041
Conditions: Malocclusion
Keywords: Orthodontics, Braces, Tooth
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: SmileSonica Inc.Industry (pharma, biotech, devices)
Study start: Jan 2013
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 10 Apr 2013 (estimated)
Results: Posted 12 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Treatment Arm	Experimental	Device: Ultrasound20 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.
Control Arm	Sham comparator	Device: Sham comparatorThe 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.

Who may qualify

Ages: 12 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

Scheduled to receive orthodontic treatment or in early stage of orthodontic treatment
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.
Available for follow-up visits.
Willing and able to sign written informed consent.
Healthy.

Key exclusion criteria (7 listed)

Any compromised medical or dental condition that prevents the subject from participating in the trial or using the medical device.
Any implanted assistive devices.
Currently involved in any other study.
Lives significantly outside the clinical trial site.
Use of bisphosphonates.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
UltrasoundAlso: Aevo System.The Aevo System™ is an ultrasound emitting dental device.	Device	Treatment Arm
Sham comparatorUltrasound 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.	Device	Control Arm

Primary outcome

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.

2 secondary outcomes

Rate of Root Resorption
Time frame: 24 weeks or until the extraction space was closed (whichever came first)
Discomfort
Time frame: 24 weeks or until the extraction space was closed (whichever came first)

Results and safety

Results posted to the registry on 12 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	49	32

Primary outcome: Rate of Tooth Movement

Time frame: 24 weeks or until the extraction space was closed (whichever came first). Mean (Standard Deviation). Unit: mm/week

Measure	Treatment Arm n = 17	Control Arm n = 17
Value	0.266 (0.0927)	0.232 (0.0855)

Treatment Arm vs Control Arm: Percent Change: 29.0, p = 0.0164, t-test, 1 sided

Population analysed: As per approved protocol, only subjects who completed the study with device usage compliance of 67% or higher and with functional devices were evaluated.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The duration of the study, up to 24 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Arm	0 of 49 (0%)	0 of 49 (0%)	0 of 49
Control Arm	0 of 49 (0%)	0 of 49 (0%)	0 of 49

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Malocclusion

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tarek El-Bialy, PhD, FRCD(C) principal investigator

University of Alberta, Department of Dentistry

Kevin L Knowlton, DDS principal investigator

Faculty of Dentistry, University of Toronto

Bryan D Tompson, DDS, FRCD(C) principal investigator

Faculty of Dentistry, University of Toronto

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound in people with Malocclusion, run by SmileSonica Inc. at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Tooth Movement (time frame: 24 weeks or until the extraction space was closed (whichever came first)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01828164.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2017.