The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment

Not Applicable

Completed

• Conditions: Malocclusion
• Interventions: Device: Extraoral OrthoPulse® PBM; Other: Fixed Orthodontic Appliance Treatment

• Registration Number: NCT02267824
• Lead Sponsor: Biolux Research Holdings, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-17
• Study First Posted: 2014-10-20
• Results First Submitted: 2016-02-15
• Results First Submitted QC: 2016-02-15
• Results First Posted: 2016-03-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extraoral OrthoPulse® PBM	Extraoral OrthoPulse® PBM	Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® photobiomudulation (PBM) treatments.
Extraoral OrthoPulse® PBM	Fixed Orthodontic Appliance Treatment	Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® photobiomudulation (PBM) treatments.
Orthodontic Treatment (Control)	Fixed Orthodontic Appliance Treatment	Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.

Primary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (4)

Department of Orthodontics, School of Dentistry, University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Shaughnessy Orthodontics; 🇺🇸 Suwanee, Georgia, United States

Clinique Dentaire Alvaro de la Fuente; 🇨🇦 L'Île-Perrot, Quebec, Canada

Department of Orthodontics, Faculty of Dentistry, Mahidol University; 🇹🇭 Bangkok, Thailand