Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time

Not Applicable

Completed

• Conditions: Malocclusion
• Interventions: Other: Fixed Orthodontic Appliance Treatment; Device: OrthoPulse™; Device: Non-Functional OrthoPulse™

• Registration Number: NCT02267850
• Lead Sponsor: Biolux Research Holdings, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-17
• Study First Posted: 2014-10-20
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2018-02
• Results First Submitted: 2018-02-27
• Results First Submitted QC: 2018-02-27
• Results First Posted: 2018-03-27
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OrthoPulse™	Fixed Orthodontic Appliance Treatment	Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.
OrthoPulse™	OrthoPulse™	Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.
Sham-Control OrthoPulse™	Non-Functional OrthoPulse™	Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).
Sham-Control OrthoPulse™	Fixed Orthodontic Appliance Treatment	Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).

Primary Outcome Measures

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

Trial Locations

Locations (1)

Shaughnessy Orthodontics; 🇺🇸 Suwanee, Georgia, United States