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Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time

Primary Purpose

Malocclusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fixed Orthodontic Appliance Treatment
OrthoPulse™
Non-Functional OrthoPulse™
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 Photobiomodulation, Orthodontic treatment, Malocclusion, OrthoPulse™

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presence of permanent dentition
  • Eligible and scheduled for full mouth fixed orthodontic treatment.
  • Class I or Class II malocclusion (no more than ½ cusp in Class II)
  • Non-extraction in all quadrants
  • Non-smoker, non-use of chewing tobacco
  • Good oral hygiene
  • No adjunct treatment such as extra or intraoral appliances
  • Age 12-40

Exclusion Criteria:

  • Pregnant females
  • Patient is currently enrolled in another clinical study
  • Non-steroidal Anti-Inflammatory drug (NSAID) use during study (Acetominophen acceptable)
  • Periodontally involved teeth
  • Use of bisphosphonates
  • Unerupted erupted teeth
  • Teeth blocked out of alignment and unable to engage initial arch wire

Sites / Locations

  • Shaughnessy Orthodontics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

OrthoPulse™

Sham-Control OrthoPulse™

Arm Description

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

Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).

Outcomes

Primary Outcome Measures

Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.
The amount of time that spans between the start of a patient's orthodontic treatment to when the qualified investigator deems the case complete, in that malocclusion is completely resolved and an acceptable clinical outcome is achieved.

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
NCT02267850
Brief Title
Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time
Official Title
Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (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 the effect of OrthoPulse™, an intra-oral LED (Light Emitting Diode) photobiomodulation device, on orthodontic treatment time. This is a double-blinded RCT with half the patients receiving treatment from a sham non-functional device, serving as controls, and the other half receiving light therapy treatment from a functional OrthoPulse™. Orthodontic treatment time for the sham-control patients are compared to that of the OrthoPulse™ patients.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OrthoPulse™
Arm Type
Experimental
Arm Description
Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.
Arm Title
Sham-Control OrthoPulse™
Arm Type
Sham Comparator
Arm Description
Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with carrying out daily non-functional OrthoPulse™ treatments (untreated control).
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). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
Intervention Type
Device
Intervention Name(s)
OrthoPulse™
Intervention Description
Patients carry out daily OrthoPulse™ treatments at home.
Intervention Type
Device
Intervention Name(s)
Non-Functional OrthoPulse™
Intervention Description
Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy.
Primary Outcome Measure Information:
Title
Overall Orthodontic Treatment Time for OrthoPulse™ and Non-OrthoPulse™ Treated Patients.
Description
The amount of time that spans between the start of a patient's orthodontic treatment to when the qualified investigator deems the case complete, in that malocclusion is completely resolved and an acceptable clinical outcome is achieved.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of permanent dentition Eligible and scheduled for full mouth fixed orthodontic treatment. Class I or Class II malocclusion (no more than ½ cusp in Class II) Non-extraction in all quadrants Non-smoker, non-use of chewing tobacco Good oral hygiene No adjunct treatment such as extra or intraoral appliances Age 12-40 Exclusion Criteria: Pregnant females Patient is currently enrolled in another clinical study Non-steroidal Anti-Inflammatory drug (NSAID) use during study (Acetominophen acceptable) Periodontally involved teeth Use of bisphosphonates Unerupted erupted teeth Teeth blocked out of alignment and unable to engage initial arch wire
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Shaughnessy, DDS
Organizational Affiliation
Shaughnessy Orthodontics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaughnessy Orthodontics
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States

12. IPD Sharing Statement

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Effect of Intra-Oral Photobiomodulation on Orthodontic Treatment Time

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