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| ID | Type | Description | Link |
|---|---|---|---|
| 197850 | Other Identifier | Health Canada |
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To study whether or not the Aevo System™ medical device enhances the rate of tooth movement in human subjects who use orthodontic braces.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound | Device | The Aevo System™ is an ultrasound emitting dental device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Tooth Movement | The weekly rate of tooth movement (mm/week) as compared between the treated side and the control side. | 24 weeks or until the extraction space was closed (whichever came first) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Root Resorption | The weekly rate of tooth root resorption (mm/week) as compared between the treated side and the control side. | 24 weeks or until the extraction space was closed (whichever came first) |
| Discomfort |
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Inclusion Criteria:
Subjects who meet all of the following criteria will qualify for entry into the study:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Tarek El-Bialy, PhD, FRCD(C) | 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 | Principal Investigator |
| Terry Carlyle, DDS, MS | Strathcona Orthodontics, Edmonton | Principal Investigator |
| William Wiltshire, BChD, ChD | Faculty of Dentistry, University of Manitoba | Principal Investigator |
| Tim Dumore, DMD, BS, MS | Dr. Dumore and Team Orthodontics, Winnipeg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 3: Strathcona Orthodontics Clinic | Edmonton | Alberta | T6E 6E8 | Canada | ||
| Site 1: University of Alberta, Facilty of Dentistry |
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11 subjects did not meet inclusion criteria after enrollment. For this reason, 60 subjects were enrolled but only 49 entered the participant flow.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Tooth Movement | The weekly rate of tooth movement (mm/week) as compared between the treated side and the control side. | As per approved protocol, only subjects who completed the study with device usage compliance of 67% or higher and with functional devices were evaluated. | Posted | Mean | Standard Deviation | mm/week | 24 weeks or until the extraction space was closed (whichever came first) |
|
The duration of the study, up to 24 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm | The side of the mouth that received treatment. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Simon, Regulatory Affairs Manager | SmileSonica Inc. | 780-975-0095 | john@johnsimon.ca |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Sham comparator | Device | 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. |
|
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.
| 24 weeks or until the extraction space was closed (whichever came first) |
| Edmonton |
| Alberta |
| T6G 2E1 |
| Canada |
| Site 4: Faculty of Dentistry, University of Manitoba | Winnipeg | Manitoba | R3E 0W2 | Canada |
| Site 5: Dr. Dumore and Team Orthodontics | Winnipeg | Manitoba | R3J 0P1 | Canada |
| Site 2: Faculty of Dentistry, University of Toronto | Toronto | Ontario | M5G 1G6 | Canada |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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The side of the mouth that was the control. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
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| Secondary | Rate of Root Resorption | The weekly rate of tooth root resorption (mm/week) as compared between the treated side and the control side. | Subjects who completed the study with device usage compliance of 67% or higher and with functional devices were evaluated. Only subjects with CBCT images were used. | Posted | Mean | Standard Deviation | mm/week | 24 weeks or until the extraction space was closed (whichever came first) |
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| Secondary | 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. | Subjects who completed the study with device usage compliance of 67% or higher. | Posted | Mean | Standard Deviation | units on a scale | 24 weeks or until the extraction space was closed (whichever came first) |
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| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Control Arm | The side of the mouth that was the control. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control. | 0 | 49 | 0 | 49 | 0 | 49 |
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