Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time

Biolux Research

Status: Completed

Conditions: Malocclusion

Treatments: Other: Fixed Orthodontic Appliance Treatment; Device: Non-Functional OrthoPulse™; Device: OrthoPulse™

Study type: Interventional

Funder types: Industry

Identifiers

NCT02267850

TS2

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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29 participants in 2 patient groups

OrthoPulse™

Experimental group

Description:

Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.

Treatment:

Other: Fixed Orthodontic Appliance Treatment

Device: OrthoPulse™

Sham-Control OrthoPulse™

Sham Comparator group

Description:

Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).

Treatment:

Other: Fixed Orthodontic Appliance Treatment

Device: Non-Functional OrthoPulse™