Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time

Completed · Not applicable · Has a placebo group

Conditions studied: Malocclusion

In brief

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.

Key facts

Study ID

NCT02267850

Run by

Biolux Research Holdings, Inc.

People needed

29

Starts

2013-05-01

Expected to finish

2016-05-01

Last updated by the study team

2018-09-21

Who can join

Age: 12 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shaughnessy Orthodontics — Suwanee, Georgia, United States

Full record on ClinicalTrials.gov

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