Status:
COMPLETED
OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study
Lead Sponsor:
Biolux Research Holdings, Inc.
Conditions:
Malocclusion
Eligibility:
All Genders
11-40 years
Phase:
NA
Brief Summary
The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, on the rate of anterior orthodontic alignment.
Eligibility Criteria
Inclusion
- Presence of permanent dentition
- Eligible and scheduled for full mouth fixed orthodontic treatment
- Class I or Class II malocclusion (no more than ½ cusp in Class II)
- Non-extraction in all quadrants
- Non-smoker
- Good oral hygiene as determined by the investigator
- No adjunct treatment such as extra- or intra-oral appliances
Exclusion
- Pregnant females
- Patient is currently enrolled in another clinical study
- Non-steroidal Anti-Inflammatory drug (NSAID) use during study (Acetominophen acceptable)
- Periodontally involved teeth
- Use of bisphosphonates
- Unerupted or partially erupted maxillary teeth
- Teeth blocked out of alignment and unable to engage initial arch wire
- Spaces present in the maxillary arch
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02267837
Start Date
December 1 2012
End Date
December 1 2013
Last Update
August 27 2018
Active Locations (1)
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1
Shaughnessy Orthodontics
Suwanee, Georgia, United States, 30024