N/A
Completed N=33
The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement
Malocclusion
Source: ClinicalTrials.gov NCT02267811 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment — 1.09; .39 millimeters per week
Summary
This open label study is designed to evaluate the ability of OrthoPulse™ to safely and effectively increase the rate of orthodontic tooth movement with fixed appliances.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment |
1.09; .39 | — |
| SECONDARY Safety Evidence of OrthoPulse™ Use |
0; 0 | — |
| SECONDARY Degree of External Apical Root Resorption (EARR) |
0.02; -0.11 | — |
Eligibility Criteria
Inclusion Criteria
- Eligible and scheduled for full mouth fixed orthodontic treatment
- Moderate to severe crowding (LII ≥ 3 mm), with no labio-lingually displaced teeth
- Class I or Class II by 1/2 cusp or less
- Non-extraction in both arches
- Age 11- 60
- Good oral hygiene
- Non-smokerInclud
Exclusion Criteria
- Pregnant females
- Patient is currently enrolled in another clinical study
- Patient decided on Invisalign® rather than braces
- Periodontally involved teeth
- Use of bisphosphonates (osteoporosis drugs) during the study
- Patient plans to move over the treatment period
- Spaces between anterior teeth
Data sourced from ClinicalTrials.gov (NCT02267811). 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.