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Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time

NCT02267850 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2018-09-21

Study results available
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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.

Conditions

  • Malocclusion

Interventions

OTHER

Fixed Orthodontic Appliance Treatment

Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.

DEVICE

OrthoPulse™

Patients carry out daily OrthoPulse™ treatments at home.

DEVICE

Non-Functional OrthoPulse™

Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy.

Sponsors & Collaborators

  • Biolux Research Holdings, Inc.

    lead INDUSTRY

Principal Investigators

  • Timothy Shaughnessy, DDS · Shaughnessy Orthodontics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02267850 on ClinicalTrials.gov