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

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ClinicalTrials.gov Identifier: NCT03202355
Recruitment Status : Terminated (Sponsor terminated due to clinical staffing changes and enrolment)
First Posted : June 28, 2017
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Biolux Research Holdings, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malocclusion Device: Fixed Appliance Orthodontic Treatment Device: OrthoPulse™ Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a two-arm, parallel, open-label, non-randomized, controlled, private practice study designed to evaluate the intended purposes of the investigation.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of OrthoPulse Photobiomodulation on the Rate of Tooth Movement During Alignment With Fixed Appliances
Actual Study Start Date : April 20, 2017
Actual Primary Completion Date : March 11, 2019
Actual Study Completion Date : March 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arms and Interventions
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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: 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.

Device: OrthoPulse™
Patients carry out daily OrthoPulse™ treatments at home.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   11 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202355


Locations
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United States, Arizona
Dickerson Orthodontics
Chandler, Arizona, United States, 85224
Dickerson Orthodontics
Peoria, Arizona, United States, 85382
Dickerson Orthodontics
Phoenix, Arizona, United States, 85028
Sponsors and Collaborators
Biolux Research Holdings, Inc.
Investigators
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Study Director: Peter Brawn, DDS Biolux Research Holdings, Inc.
More Information
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Publications:

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Responsible Party: Biolux Research Holdings, Inc.
ClinicalTrials.gov Identifier: NCT03202355    
Other Study ID Numbers: BX11
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Biolux Research Holdings, Inc.:
Alignment phase
Photobiomodulation
Orthodontic treatment
Malocclusion
OrthoPulse™
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases