Clinical Trial: The Effect of OrthoPulse™ Photobiomodulation on Tooth Movement and Treatment Time When Used With Invisalign Treatment

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Effect of OrthoPulse™ Photobiomodulation on Tooth Movement and Treatment Time When Used With Invisalign Treatment

Brief Summary: The aim of the study is to determine if, and to what degree photobiomodulation treatment with OrthoPulse has an effect on the rate of tooth movement during alignment for patients receiving Invisalign orthodontic aligner treatment.

Detailed Summary:
Sponsor: Biolux Research Ltd.

Current Primary Outcome: Rate of tooth movement [ Time Frame: From date of enrolment until the date of completion of the last Invisalign aligner, assessed every 4-6 weeks up to 2 years ]

Tooth position will be measured at the end of aligners 6 (4-6 weeks), 12 (8-12 weeks), 18 (12-18 weeks), at the end first series of aligners at refinement, and at the end of treatment. Rates will be measured end of use of each individual Invisalign time point in order to determine whether the application of photobiomodulation increases the rate of tooth movement with Invisalign treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of treatment time [ Time Frame: From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years ]
    Treatment time will be calculated as the number of days from the first day until the last day the subject wears Invisalign aligners. To evaluate whether the application of photobiomodulation decreases the total treatment time with Invisalign treatment, the measured length of time will be compared against the expected treatment time.
  • Effect of photobiomodulation on external apical root resorption [ Time Frame: From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years ]
    Root lengths will be measured from panoramic radiographs to evaluate whether the application of photobiomodulation decreases the total amount of external apical root resorption over the course of the treatment,


Original Secondary Outcome: Same as current

Information By: Biolux Research Ltd.

Dates:
Date Received: October 31, 2016
Date Started: July 2016
Date Completion: July 2018
Last Updated: November 1, 2016
Last Verified: November 2016