Status:
COMPLETED
Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time
Lead Sponsor:
Biolux Research Holdings, Inc.
Conditions:
Malocclusion
Eligibility:
All Genders
12-40 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 orthodontic treatment time. This is a double-blinded RCT with ha...
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, non-use of chewing tobacco
- Good oral hygiene
- No adjunct treatment such as extra or intraoral appliances
- Age 12-40
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 erupted teeth
- Teeth blocked out of alignment and unable to engage initial arch wire
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02267850
Start Date
May 1 2013
End Date
May 1 2016
Last Update
September 21 2018
Active Locations (1)
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1
Shaughnessy Orthodontics
Suwanee, Georgia, United States, 30024