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. ]

The amount of time that spans between the start of a patient's orthodontic treatment to when the qualified investigator deems the case complete, in that malocclusion is completely resolved and an acceptable clinical outcome is achieved.


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. ]

The amount of time that spans between the start of a patient's orthodontic treatment to when the qualified investigator deems the case complete, in that malocclusion is completely resolved and an acceptable clinical outcome is achieved.


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