NCT02267850

Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time

Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time: A Randomized Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Biolux Research Holdings, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

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 half the patients receiving treatment from a sham non-functional device, serving as controls, and the other half receiving light therapy treatment from a functional OrthoPulse™. Orthodontic treatment time for the sham-control patients are compared to that of the OrthoPulse™ patients.

Conditions

• Malocclusion

Interventions

Type	Name	Description
OTHER	Fixed Orthodontic Appliance Treatment	Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
DEVICE	OrthoPulse™	Patients carry out daily OrthoPulse™ treatments at home.
DEVICE	Non-Functional OrthoPulse™	Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy.

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-10-20
• Last updated: 2018-09-21
• Results posted: 2018-03-27

Locations

1 site across 1 country: United States