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

April 4, 2019 updated by: Biolux Research Holdings, Inc.
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Dickerson Orthodontics
      • Peoria, Arizona, United States, 85382
        • Dickerson Orthodontics
      • Phoenix, Arizona, United States, 85028
        • Dickerson Orthodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1 (Control)
Subjects assigned to this group receive fixed appliance orthodontic treatment only
Device: Fixed Appliance Orthodontic Treatment
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.
EXPERIMENTAL: Group 2 (OP1)
Subjects assigned to this group receive fixed appliance orthodontic treatment in conjunction with receiving daily OrthoPulse™ treatments.
Device: OrthoPulse™
Patients carry out daily OrthoPulse™ treatments at home.
Device: Fixed Appliance Orthodontic Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of tooth movement in OrthoPulse treated and non-OrthoPulse treated patients
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.
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of OrthoPulse PBM on external apical root resorption (EARR)
Time Frame: 6 months after the start of orthodontic treatment
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.
6 months after the start of orthodontic treatment
Risk of OrthoPulse PBM to the patient.
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
Patients from both groups will be questioned and assessed at regularly scheduled visits for treatment-related adverse events.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biolux Research Holdings, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 20, 2017

Primary Completion (ACTUAL)

March 11, 2019

Study Completion (ACTUAL)

March 11, 2019

Study Registration Dates

First Submitted

June 19, 2017

First Submitted That Met QC Criteria

June 26, 2017

First Posted (ACTUAL)

June 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BX11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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