CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
Fixed Orthodontic Appliance Treatment +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02267850
NCT02267850N/ACompleted

Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time: A Randomized Control Trial

Biolux Research Holdings, Inc.·interventional·Posted Oct 20, 2014·Updated Sep 21, 2018

In Brief

A clinical study evaluating Fixed Orthodontic Appliance Treatment, OrthoPulse™, and 1 other intervention for Malocclusion. Completed, enrolled 29 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalocclusion
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 20, 2014
Enrollment StartMay 1, 2013
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 11.7 years ago

Interventions

Fixed Orthodontic Appliance Treatmentother

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.

OrthoPulse™device

Patients carry out daily OrthoPulse™ treatments at home.

Non-Functional OrthoPulse™device

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