Malocclusion
Conditions
Keywords
Orthodontics, Braces, Tooth
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.
Interventions
DEVICEUltrasound
The Aevo System™ is an ultrasound emitting dental device.
DEVICESham 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.
Sponsors
SmileSonica Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
Yes
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Tooth Movement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Root Resorption | 24 weeks or until the extraction space was closed (whichever came first) | The weekly rate of tooth root resorption (mm/week) as compared between the treated side and the control side. |
| Discomfort | 24 weeks or until the extraction space was closed (whichever came first) | 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. |
Countries
Canada
Participant flow
Pre-assignment details
11 subjects did not meet inclusion criteria after enrollment. For this reason, 60 subjects were enrolled but only 49 entered the participant flow.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49 |
| Total | 49 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 18.4 years STANDARD_DEVIATION 5.77 |
| Region of Enrollment Canada | 49 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 |
| other Total, other adverse events | 0 / 49 | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
Primary
Rate of Tooth Movement
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)
Population: As per approved protocol, only subjects who completed the study with device usage compliance of 67% or higher and with functional devices were evaluated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Rate of Tooth Movement | 0.266 mm/week | Standard Deviation 0.0927 |
| Control Arm | Rate of Tooth Movement | 0.232 mm/week | Standard Deviation 0.0855 |
p-value: 0.0164t-test, 1 sided
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.
Time frame: 24 weeks or until the extraction space was closed (whichever came first)
Population: Subjects who completed the study with device usage compliance of 67% or higher.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Discomfort | 1.990 units on a scale | Standard Deviation 2.03 |
| Control Arm | Discomfort | 2.000 units on a scale | Standard Deviation 1.713 |
p-value: <0.001Bootstrapped mean difference
Secondary
Rate of Root Resorption
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)
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Arm | Rate of Root Resorption | 0.0092 mm/week | Standard Deviation 0.0226 |
| Control Arm | Rate of Root Resorption | 0.0241 mm/week | Standard Deviation 0.0223 |
p-value: 0.0423t-test, 1 sided