Clinical Trial: OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study.

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.

Detailed Summary:
Sponsor: Biolux Research Ltd.

Current Primary Outcome: Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for OrthoPulse™ and Non-OrthoPulse™ Treated Patients. [ Time Frame: Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case. ]

Original Primary Outcome: To determine if intra-oral photobiomodulation, by means of the intra-oral OrthoPulse™, reduces the treatment time in the alignment phase of orthodontic treatment. [ Time Frame: Participants will be followed for the time it take them to complete orthodontic anterior levelling and alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case and whether tx or ctrl. ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Biolux Research Ltd.

Dates:
Date Received: October 10, 2014
Date Started: December 2012
Date Completion:
Last Updated: August 12, 2015
Last Verified: August 2015