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

January 14, 2019 updated by: Biolux Research Holdings, Inc.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

167

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
    • Minnesota
      • Maple Grove, Minnesota, United States, 55369
        • Kottemann Orthodontics
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Chenin Orthodontics
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Orthodontic Associates

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I7: Control
Subjects assigned to this group receive no OrthoPulse™ treatment, and switch Invisalign aligners every 7 days.
Device: Invisalign (7 day)
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.
Experimental: OP7: OrthoPulse Treatment
Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 7 days.
Device: Invisalign (7 day)
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.
Device: OrthoPulse
Daily 10 minute (5 minutes per arch) OrthoPulse treatments are administered at home.
Experimental: OP5: OrthoPulse Treatment
Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 5 days.
Device: OrthoPulse
Daily 10 minute (5 minutes per arch) OrthoPulse treatments are administered at home.
Device: Invisalign (5 day)
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.
Experimental: OP3.5: OrthoPulse Treatment
Subjects assigned to this group receive daily OrthoPulse™ treatments, and switch Invisalign aligners every 3.5 days.
Device: OrthoPulse
Daily 10 minute (5 minutes per arch) OrthoPulse treatments are administered at home.
Device: Invisalign (3.5 day)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of tooth movement
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
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
Length of treatment time
Time Frame: From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years
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.
From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years
Effect of photobiomodulation on external apical root resorption
Time Frame: From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years
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,
From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years

Collaborators and Investigators

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

Sponsor

Biolux Research Holdings, Inc.

Investigators

  • Study Director: Peter Brawn, DDS, Biolux Research

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

July 1, 2016

Primary Completion (Anticipated)

April 1, 2019

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

October 31, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BX9

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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