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

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ClinicalTrials.gov Identifier: NCT02954133
Recruitment Status : Active, not recruiting
First Posted : November 3, 2016
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Biolux Research Ltd.

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.

Condition or disease Intervention/treatment Phase
Malocclusion Device: Invisalign (7 day) Device: Invisalign (5 day) Device: OrthoPulse Device: Invisalign (3.5 day) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of OrthoPulse™ Photobiomodulation on Tooth Movement and Treatment Time When Used With Invisalign Treatment
Study Start Date : July 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

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: 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.

Device: OrthoPulse
Daily 10 minute (5 minutes per arch) OrthoPulse treatments are administered at home.

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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,



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02954133


Locations
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United States, Arizona
Dickerson Orthodontics
Chandler, Arizona, United States, 85224
United States, Minnesota
Kottemann Orthodontics
Maple Grove, Minnesota, United States, 55369
United States, Nevada
Chenin Orthodontics
Henderson, Nevada, United States, 89052
United States, Oklahoma
Orthodontic Associates
Oklahoma City, Oklahoma, United States, 73120
Sponsors and Collaborators
Biolux Research Ltd.
Investigators
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Study Director: Peter Brawn, DDS Biolux Research

Publications:

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Responsible Party: Biolux Research Ltd.
ClinicalTrials.gov Identifier: NCT02954133     History of Changes
Other Study ID Numbers: BX9
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Keywords provided by Biolux Research Ltd.:
Alignment phase
Photobiomodulation
Orthodontic treatment
Malocclusion
OrthoPulse™
Invisalign
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases