Trial Outcomes & Findings for The Effect of Ultrasound on Orthodontic Tooth Movement (NCT NCT01828164)
NCT ID: NCT01828164
Last Updated: 2017-05-22
Results Overview
The weekly rate of tooth movement (mm/week) as compared between the treated side and the control side.
COMPLETED
NA
60 participants
24 weeks or until the extraction space was closed (whichever came first)
2017-05-22
Participant Flow
11 subjects did not meet inclusion criteria after enrollment. For this reason, 60 subjects were enrolled but only 49 entered the participant flow.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Ultrasound on Orthodontic Tooth Movement
Baseline characteristics by cohort
| Measure |
All Study Participants
n=49 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.
|
|---|---|
|
Age, Continuous
|
18.4 years
STANDARD_DEVIATION 5.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
The weekly rate of tooth movement (mm/week) as compared between the treated side and the control side.
Outcome measures
| Measure |
Treatment Arm
n=17 Participants
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.
|
Control Arm
n=17 Participants
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.
|
|---|---|---|
|
Rate of Tooth Movement
|
0.266 mm/week
Standard Deviation 0.0927
|
0.232 mm/week
Standard Deviation 0.0855
|
SECONDARY outcome
Timeframe: 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.
The weekly rate of tooth root resorption (mm/week) as compared between the treated side and the control side.
Outcome measures
| Measure |
Treatment Arm
n=13 Participants
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.
|
Control Arm
n=13 Participants
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.
|
|---|---|---|
|
Rate of Root Resorption
|
0.0092 mm/week
Standard Deviation 0.0226
|
0.0241 mm/week
Standard Deviation 0.0223
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Treatment Arm
n=24 Participants
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.
|
Control Arm
n=24 Participants
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.
|
|---|---|---|
|
Discomfort
|
1.990 units on a scale
Standard Deviation 2.030
|
2.000 units on a scale
Standard Deviation 1.713
|
Adverse Events
Treatment Arm
Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John Simon, Regulatory Affairs Manager
SmileSonica Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60