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A Randomized Clinical Trial Evaluating the Efficacy of OrthoPulse device- a Molecular Level Study
Clinical Trial ( IRB ) #: 19-056-2
Title: A Randomized Clinical Trial Evaluating the Efficacy of OrthoPulse device- a Molecular Level Study
Principal Investigator: Dr. Sumit Yadav
Description: There is insufficient evidence to support the widespread clinical usage of the of OrthoPulse™, as a PBM device. Furthermore, to date, none of the human randomized trials sufficiently explain the mechanism of PBM devices on molecular level. In our study design, we are proposing an adequate sample size, proper randomization, blinding and variable samples to be processed both micro and macro level. Thus, we believe that, this study may provide strong evidence about PBM/OrthoPulseTM (Low Laser Light Therapy) usage in both accelerated orthodontics and reduction in overall treatment time as well as its mode of action at molecular level. The study overlaps usual (SOC) orthodontic care visits for up to 30 weeks. Target group includes subjects from age 11-35. There is a potential benefit in that with usage of device, time to treat/complete effective alignment may be shortened.
Classification:
  Dental, Including Mouth
Eligibility Criteria: Check with study contact
How to Contact: Shivam Mehta. Telephone: Not Available. Email: smehta@uchc.edu
Enrollment Status/Comments: Enrolling/recruiting. For current recruitment status, please check with study contact.