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

N/ATerminatedNCT03202355

Biolux Research Holdings, Inc.10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malocclusion

Interventions

Fixed Appliance Orthodontic TreatmentDEVICE

Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.

OrthoPulse™DEVICE

Patients carry out daily OrthoPulse™ treatments at home.

Eligibility

Sex: ALLMin age: 11 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Dickerson Orthodontics

Chandler, Arizona, United States

Dickerson Orthodontics

Peoria, Arizona, United States

Dickerson Orthodontics

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Rate of tooth movement in OrthoPulse treated and non-OrthoPulse treated patients

Rate of tooth movement will be evaluated based on the duration of time and amount of tooth movement required to reach Little's Irregularity Index (LII) of less than approximately 2 mm but greater than 0 mm, as determined by the qualified investigator.

Time frame: From start of treatment until Little's Irregularity Index (LII) reaches less than approximately 2 mm but greater than 0 mm, no more than 6 months after the start of treatment.

Secondary Outcomes

Effect of OrthoPulse PBM on external apical root resorption (EARR)

Root lengths from patients will be measured using panoramic radiographs at the start of treatment and 6 months after the start of treatment. These measurements will be used to determine and compare EARR between each of the two groups.

Time frame: 6 months after the start of orthodontic treatment

Risk of OrthoPulse PBM to the patient.

Patients from both groups will be questioned and assessed at regularly scheduled visits for treatment-related adverse events.

Time frame: 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

Data from ClinicalTrials.gov

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