Clinical Trial: Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time: A Randomized Control Trial
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 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.
Detailed Summary:
Sponsor: Biolux Research Ltd.
Current Primary Outcome: Overall orthodontic treatment time for OrthoPulse™ and non-OrthoPulse™ treated patients. [ Time Frame: Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case. ]
Original Primary Outcome: To observe the overall orthodontic treatment time for patients receiving daily OrthoPulse™ treatment and patients not receiving OrthoPulse™ treatment. [ Time Frame: Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case and whether treated or sham-control. ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Biolux Research Ltd.
Dates:
Date Received: October 10, 2014
Date Started: May 2013
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016