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The Effect of OrthoPulse™ Photobiomodulation on Tooth Movement and Treatment Time When Used With Invisalign Treatment

Primary Purpose

Malocclusion

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Invisalign (7 day)
Invisalign (5 day)
OrthoPulse
Invisalign (3.5 day)
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™, Invisalign

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Invisalign "Full Treatment" product only

  • Have a permanent dentition

    • 18 years-old
  • Angle Class I or ½ cusp Class II molar and canine relationship
  • Moderate to mild crowding in at least one arch

Exclusion Criteria:

  • Subjects who do not fulfill all inclusion criteria requirements
  • Craniofacial anomaly present
  • Past or present signs and symptoms of periodontal disease
  • A significant medical or medication history that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement
  • Previous orthodontic or orthopedic relapse within 1 year
  • History of trauma, bruxism, or parafunction
  • Skeletal jaw discrepancy
  • Use of osteoporosis drugs
  • Initial use of auxiliary mechanics such as elastics

Sites / Locations

  • Dickerson Orthodontics
  • Kottemann Orthodontics
  • Chenin Orthodontics
  • Orthodontic Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

I7: Control

OP7: OrthoPulse Treatment

OP5: OrthoPulse Treatment

OP3.5: OrthoPulse Treatment

Arm Description

Subjects assigned to this group receive no OrthoPulse™ treatment, and switch Invisalign aligners every 7 days.

Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 7 days.

Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 5 days.

Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 3.5 days.

Outcomes

Primary Outcome Measures

Rate of tooth movement
Tooth position will be measured at the end of aligners 6 (4-6 weeks), 12 (8-12 weeks), 18 (12-18 weeks), at the end first series of aligners at refinement, and at the end of treatment. Rates will be measured end of use of each individual Invisalign time point in order to determine whether the application of photobiomodulation increases the rate of tooth movement with Invisalign treatment.

Secondary Outcome Measures

Length of treatment time
Treatment time will be calculated as the number of days from the first day until the last day the subject wears Invisalign aligners. To evaluate whether the application of photobiomodulation decreases the total treatment time with Invisalign treatment, the measured length of time will be compared against the expected treatment time.
Effect of photobiomodulation on external apical root resorption
Root lengths will be measured from panoramic radiographs to evaluate whether the application of photobiomodulation decreases the total amount of external apical root resorption over the course of the treatment,

Full Information

First Posted
October 31, 2016
Last Updated
January 14, 2019
Sponsor
Biolux Research Holdings, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02954133
Brief Title
The Effect of OrthoPulse™ Photobiomodulation on Tooth Movement and Treatment Time When Used With Invisalign Treatment
Official Title
The Effect of OrthoPulse™ Photobiomodulation on Tooth Movement and Treatment Time When Used With Invisalign Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

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 the study is to determine if, and to what degree photobiomodulation treatment with OrthoPulse has an effect on the rate of tooth movement during alignment for patients receiving Invisalign orthodontic aligner treatment.

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™, Invisalign

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
I7: Control
Arm Type
Experimental
Arm Description
Subjects assigned to this group receive no OrthoPulse™ treatment, and switch Invisalign aligners every 7 days.
Arm Title
OP7: OrthoPulse Treatment
Arm Type
Experimental
Arm Description
Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 7 days.
Arm Title
OP5: OrthoPulse Treatment
Arm Type
Experimental
Arm Description
Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 5 days.
Arm Title
OP3.5: OrthoPulse Treatment
Arm Type
Experimental
Arm Description
Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 3.5 days.
Intervention Type
Device
Intervention Name(s)
Invisalign (7 day)
Intervention Description
Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 7 days.
Intervention Type
Device
Intervention Name(s)
Invisalign (5 day)
Intervention Description
Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 5 days.
Intervention Type
Device
Intervention Name(s)
OrthoPulse
Intervention Description
Daily 10 minute (5 minutes per arch) OrthoPulse treatments are administered at home.
Intervention Type
Device
Intervention Name(s)
Invisalign (3.5 day)
Intervention Description
Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 3.5 days.
Primary Outcome Measure Information:
Title
Rate of tooth movement
Description
Tooth position will be measured at the end of aligners 6 (4-6 weeks), 12 (8-12 weeks), 18 (12-18 weeks), at the end first series of aligners at refinement, and at the end of treatment. Rates will be measured end of use of each individual Invisalign time point in order to determine whether the application of photobiomodulation increases the rate of tooth movement with Invisalign treatment.
Time Frame
From date of enrolment until the date of completion of the last Invisalign aligner, assessed every 4-6 weeks up to 2 years
Secondary Outcome Measure Information:
Title
Length of treatment time
Description
Treatment time will be calculated as the number of days from the first day until the last day the subject wears Invisalign aligners. To evaluate whether the application of photobiomodulation decreases the total treatment time with Invisalign treatment, the measured length of time will be compared against the expected treatment time.
Time Frame
From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years
Title
Effect of photobiomodulation on external apical root resorption
Description
Root lengths will be measured from panoramic radiographs to evaluate whether the application of photobiomodulation decreases the total amount of external apical root resorption over the course of the treatment,
Time Frame
From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Invisalign "Full Treatment" product only Have a permanent dentition 18 years-old Angle Class I or ½ cusp Class II molar and canine relationship Moderate to mild crowding in at least one arch Exclusion Criteria: Subjects who do not fulfill all inclusion criteria requirements Craniofacial anomaly present Past or present signs and symptoms of periodontal disease A significant medical or medication history that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement Previous orthodontic or orthopedic relapse within 1 year History of trauma, bruxism, or parafunction Skeletal jaw discrepancy Use of osteoporosis drugs Initial use of auxiliary mechanics such as elastics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Brawn, DDS
Organizational Affiliation
Biolux Research
Official's Role
Study Director
Facility Information:
Facility Name
Dickerson Orthodontics
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Kottemann Orthodontics
City
Maple Grove
State/Province
Minnesota
ZIP/Postal Code
55369
Country
United States
Facility Name
Chenin Orthodontics
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Orthodontic Associates
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States

12. IPD Sharing Statement

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The Effect of OrthoPulse™ Photobiomodulation on Tooth Movement and Treatment Time When Used With Invisalign Treatment

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