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OpenTrials
Completed

NCT Number: NCT02267850

Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time

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.

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Key information

Conditions

Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

12 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, non-use of chewing tobacco
  • Good oral hygiene
  • No adjunct treatment such as extra or intraoral appliances
  • Age 12-40

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 erupted teeth
  • Teeth blocked out of alignment and unable to engage initial arch wire

Treatment and study plan

Fixed Orthodontic Appliance Treatment

Other

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.

Primary outcomes

  1. Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.

    Time frame: Participants will be followed for the duration of their orthodontic treatment, an expected average of 1-2 years, depending on the severity of the case.

    The amount of time that spans between the start of a patient's orthodontic treatment to when the qualified investigator deems the case complete, in that malocclusion is completely resolved and an acceptable clinical outcome is achieved.

Sponsors and collaborators

Lead sponsor

Biolux Research Holdings, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 20, 2014
Registry last updated
Sep 21, 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.

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