N/A
N=49
The Effect of Ultrasound on Orthodontic Tooth Movement
Malocclusion
Bottom Line
View on ClinicalTrials.gov: NCT01828164 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Rate of Tooth Movement — 0.266; 0.232 mm/week — p=0.0164
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ultrasound (Device); Sham comparator (Device)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- SmileSonica Inc.
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Tooth Movement |
0.266; 0.232 | 0.0164 sig |
| SECONDARY Rate of Root Resorption |
0.0092; 0.0241 | 0.0423 sig |
| SECONDARY Discomfort |
1.990; 2.000 | <0.001 sig |
Summary
To study whether or not the Aevo System™ medical device enhances the rate of tooth movement in human subjects who use orthodontic braces.
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 .
Data sourced from ClinicalTrials.gov (NCT01828164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.