The Effect of OrthoPulse Photobiomodulation on the Rate of Tooth Movement During Alignment With Fixed Appliances

Biolux Research

Status: Terminated

Conditions: Malocclusion

Treatments: Device: OrthoPulse™; Device: Fixed Appliance Orthodontic Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT03202355

BX11

Details and patient eligibility

About

The aim of this study is to determine efficacy of OrthoPulse photobiomodulation on the rate of tooth movement during alignment for Subjects receiving fixed appliance orthodontic treatment.

Enrollment: 10 patients

Sex: All

Ages: 11 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Presence of permanent dentition
• Eligible and scheduled for full-mouth, fixed-appliance orthodontic treatment
• Moderate to severe crowding (LII ≥ 3 mm), with no labio-lingually displaced teeth
• Class I or Class II malocclusion by ½ cusp or less
• Non-extraction in both arches
• Age 11-60
• Good oral hygiene
• Non-smoker; non-use of chewing tobacco

Exclusion criteria

• Subject is currently enrolled in another clinical study
• Subject decided on Invisalign rather than braces
• Periodontally involved teeth
• Use of bisphosphonates (osteoporosis drugs) during the study
• Subject plans to relocate over the treatment period
• Spaces between anterior teeth
• Subject has dental implants or an implanted prosthesis
• Sponsor employees, the Investigator and staff, as well as their immediate family members

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Group 1 (Control)

Experimental group

Description:

Subjects assigned to this group receive fixed appliance orthodontic treatment only

Treatment:

Device: Fixed Appliance Orthodontic Treatment

Group 2 (OP1)

Experimental group

Description:

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

Treatment:

Device: Fixed Appliance Orthodontic Treatment

Device: OrthoPulse™