Status:
COMPLETED
The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement
Lead Sponsor:
Biolux Research Holdings, Inc.
Conditions:
Malocclusion
Eligibility:
All Genders
11-60 years
Phase:
NA
Brief 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.
Detailed Description
The primary aim of this study is to determine if daily OrthoPulse™ use affects the rate of orthodontic tooth movement during alignment with fixed appliances in the mandibular arch. The secondary aim ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02267811
Start Date
October 1 2013
End Date
June 1 2016
Last Update
May 21 2019
Active Locations (1)
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1
Stone Oak Orthodontics
San Antonio, Texas, United States, 78232