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

Completed · Not applicable

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 the rate of anterior orthodontic alignment.

Key facts

Study ID

NCT02267837

Run by

Biolux Research Holdings, Inc.

People needed

20

Starts

2012-12-01

Expected to finish

2013-12-01

Last updated by the study team

2018-08-27

Who can join

Age: 11 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
• Good oral hygiene as determined by the investigator
• No adjunct treatment such as extra- or intra-oral appliances

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 or partially erupted maxillary teeth
• Teeth blocked out of alignment and unable to engage initial arch wire
• Spaces present in the maxillary arch

Where it is running

• Shaughnessy Orthodontics — Suwanee, Georgia, United States

Full record on ClinicalTrials.gov

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