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The Effect of Ultrasound on Orthodontic Tooth Movement

Primary Purpose

Malocclusion

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Ultrasound

Sham comparator

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring Orthodontics, Braces, Tooth

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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 .

Sites / Locations

Site 3: Strathcona Orthodontics Clinic
Site 1: University of Alberta, Facilty of Dentistry
Site 4: Faculty of Dentistry, University of Manitoba
Site 5: Dr. Dumore and Team Orthodontics
Site 2: Faculty of Dentistry, University of Toronto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment Arm

Control Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rate of Tooth Movement

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

The weekly rate of tooth root resorption (mm/week) as compared between the treated side and the control side.

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.

Full Information

NCT ID

NCT01828164

First Posted

April 3, 2013

Last Updated

April 11, 2017

Sponsor

SmileSonica Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01828164

Brief Title

The Effect of Ultrasound on Orthodontic Tooth Movement

Official Title

The Effect of Ultrasound on Orthodontic Tooth Movement

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SmileSonica Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malocclusion

Keywords

Orthodontics, Braces, Tooth

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm

Arm Type

Experimental

Arm Description

Arm Title

Control Arm

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Ultrasound

Other Intervention Name(s)

Aevo System.

Intervention Description

The Aevo System™ is an ultrasound emitting dental device.

Intervention Type

Device

Intervention Name(s)

Sham comparator

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of Tooth Movement

Description

The weekly rate of tooth movement (mm/week) as compared between the treated side and the control side.

Time Frame

24 weeks or until the extraction space was closed (whichever came first)

Secondary Outcome Measure Information:

Title

Rate of Root Resorption

Description

The weekly rate of tooth root resorption (mm/week) as compared between the treated side and the control side.

Time Frame

24 weeks or until the extraction space was closed (whichever came first)

Title

Discomfort

Description

Time Frame

24 weeks or until the extraction space was closed (whichever came first)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 .

Overall Study Officials: