OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study

The aim of this study is to determine the effect of OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, on the rate of anterior 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

Shaughnessy Orthodontics

Suwanee, Georgia, 30024, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Presence of permanent dentition
Eligible and scheduled for full mouth fixed orthodontic treatment
Class I or Class II malocclusion (no more than ½ cusp in Class II)
Non-extraction in all quadrants
Non-smoker
Good oral hygiene as determined by the investigator
No adjunct treatment such as extra- or intra-oral appliances

Exclusion criteria

Pregnant females
Patient is currently enrolled in another clinical study
Non-steroidal Anti-Inflammatory drug (NSAID) use during study (Acetominophen acceptable)
Periodontally involved teeth
Use of bisphosphonates
Unerupted or partially erupted maxillary teeth
Teeth blocked out of alignment and unable to engage initial arch wire
Spaces present in the maxillary arch

Treatment and study plan

OrthoPulse™

Device

Patients carry out daily OrthoPulse™ treatments at home.

Primary outcomes

Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for OrthoPulse™ and Non-OrthoPulse™ 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

Official study title

OrthoPulse™ and Its Effect on the Rate of Orthodontic Tooth Alignment: A Pilot Feasibility Study.

Important dates

Study start: 2012
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