The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment

Biolux Research

Status: Completed

Conditions: Malocclusion

Treatments: Device: Extraoral OrthoPulse® PBM; Other: Fixed Orthodontic Appliance Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02267824

OP2

Details and patient eligibility

About

The aim of this study is to determine if extraoral OrthoPulse®, which emits extraoral LED (Light Emitting Diode) photobiomodulation (PBM), reduces the time it takes to complete orthodontic alignment.

Enrollment: 101 patients

Sex: All

Ages: 11 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Permanent dentition
• Class I malocclusion with irregularity score of greater than 2 mm in either arch
• Good oral hygiene

Exclusion criteria

• Any medical or dental condition that could potentially affect study results
• Patients currently using any investigational drug or any other investigational device
• Patients planning to relocate or move during the treatment period
• Use of bisphosphonates
• Pregnant females

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 2 patient groups

Extraoral OrthoPulse® PBM

Experimental group

Description:

Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® photobiomudulation (PBM) treatments.

Treatment:

Other: Fixed Orthodontic Appliance Treatment

Device: Extraoral OrthoPulse® PBM

Orthodontic Treatment (Control)

Other group

Description:

Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.

Treatment:

Other: Fixed Orthodontic Appliance Treatment