The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment

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.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

11 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Dentaire Alvaro de la Fuente, L'Ile Perrot, Quebec, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extraoral OrthoPulse® PBM

Device

Patients carry out daily extraoral OrthoPulse® PBM treatments at home.

Fixed Orthodontic Appliance Treatment

Other

Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office.

Primary outcomes

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.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Biolux Research Holdings, Inc.

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Oct 20, 2014
Registry last updated: Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed