The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement
NCT ID: NCT02267811
Last Updated: 2019-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2013-10-31
2016-06-30
Brief Summary
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Detailed Description
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The secondary aim of this study is to determine whether patients treated with OrthoPulse demonstrate root resorption beyond what is commonly expected during orthodontic treatment.
The study also aims to collect confirmatory evidence on the safety of the device.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fixed Orthodontic Treatment with OrthoPulse™
Subjects assigned to this group receive orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
Orthodontic Treatment
Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
OrthoPulse™
Participants carry out daily OrthoPulse™ treatments at home.
Fixed Orthodontic Treatment
Subjects assigned to this group receive orthodontic treatment with no OrthoPulse™ treatment.
Orthodontic Treatment
Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
Interventions
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Orthodontic Treatment
Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
OrthoPulse™
Participants carry out daily OrthoPulse™ treatments at home.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
11 Years
60 Years
ALL
No
Sponsors
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Biolux Research Holdings, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Brawn, DDS
Role: STUDY_DIRECTOR
Biolux Research
Locations
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Stone Oak Orthodontics
San Antonio, Texas, United States
Countries
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References
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Other Identifiers
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BX8RN
Identifier Type: -
Identifier Source: org_study_id
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