Clinical trial NCT02267824: The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment
Official title: The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: Alignment phase
Photobiomodulation
Orthodontic treatment
Malocclusion
OrthoPulse™
Lead sponsor: Biolux Research Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 101
Sex: ALL
Minimum age (years): 11
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine if extraoral OrthoPulse®, which emits extraoral LED (Light Emitting Diode) photobiomodulation (PBM), reduces the time it takes to complete orthodontic alignment.


Eligibility criteria: Inclusion Criteria:

* Permanent dentition
* Class I malocclusion with irregularity score of greater than 2 mm in either arch
* Good oral hygiene

Exclusion Criteria:

* Any medical or dental condition that could potentially affect study results
* Patients currently using any investigational drug or any other investigational device
* Patients planning to relocate or move during the treatment period
* Use of bisphosphonates
* Pregnant females

Primary outcomes:
measure: Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Department of Orthodontics, School of Dentistry, University of Alabama
state: Alabama
city: Suwanee
country: United States
facility: Shaughnessy Orthodontics
state: Georgia
city: L'Île-Perrot
country: Canada
facility: Clinique Dentaire Alvaro de la Fuente
state: Quebec
city: Bangkok
country: Thailand
facility: Department of Orthodontics, Faculty of Dentistry, Mahidol University
Study officials:
affiliation: University of Alabama (UAB) Birmingham
name: Chung H Kau, DDS
role: PRINCIPAL_INVESTIGATOR
References:
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