N/A
Completed N=49
The Effect of Ultrasound on Orthodontic Tooth Movement
Malocclusion
Source: ClinicalTrials.gov NCT01828164 ↗
Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Rate of Tooth Movement — 0.266; 0.232 mm/week — p=0.0164
Summary
To study whether or not the Aevo System™ medical device enhances the rate of tooth movement in human subjects who use orthodontic braces.
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 |
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. Informational only — not medical advice.