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The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment

Primary Purpose

Malocclusion

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Extraoral OrthoPulse® PBM
Fixed Orthodontic Appliance Treatment
Sponsored by
Biolux Research Holdings, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring Alignment phase, Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™

Eligibility Criteria

11 Years - 40 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Orthodontics, School of Dentistry, University of Alabama
  • Shaughnessy Orthodontics
  • Clinique Dentaire Alvaro de la Fuente
  • Department of Orthodontics, Faculty of Dentistry, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Extraoral OrthoPulse® PBM

Orthodontic Treatment (Control)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients.

Secondary Outcome Measures

Full Information

First Posted
October 10, 2014
Last Updated
August 23, 2018
Sponsor
Biolux Research Holdings, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02267824
Brief Title
The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment
Official Title
The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biolux Research Holdings, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
Alignment phase, Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extraoral OrthoPulse® PBM
Arm Type
Experimental
Arm Description
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® photobiomudulation (PBM) treatments.
Arm Title
Orthodontic Treatment (Control)
Arm Type
Other
Arm Description
Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.
Intervention Type
Device
Intervention Name(s)
Extraoral OrthoPulse® PBM
Intervention Description
Patients carry out daily extraoral OrthoPulse® PBM treatments at home.
Intervention Type
Other
Intervention Name(s)
Fixed Orthodontic Appliance Treatment
Intervention Description
Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office.
Primary Outcome Measure Information:
Title
Rate of Orthodontic Anterior Alignment in Millimetres Per Week (mm/wk) by Means of Little's Irregularity Index (LII) for Extraoral OrthoPulse® PBM and Non-OrthoPulse® PBM Treated Patients.
Time Frame
Participants followed for the time it takes to complete orthodontic anterior alignment, an expected average of 30-120 days from the start of orthodontic treatment, depending on the severity of the case.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung H Kau, DDS
Organizational Affiliation
University of Alabama (UAB) Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthodontics, School of Dentistry, University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Shaughnessy Orthodontics
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Clinique Dentaire Alvaro de la Fuente
City
L'Île-Perrot
State/Province
Quebec
ZIP/Postal Code
J7V 4X4
Country
Canada
Facility Name
Department of Orthodontics, Faculty of Dentistry, Mahidol University
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Citations:
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The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment

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