Clinical trial NCT02954133: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Malocclusion
Keywords: Alignment phase
Photobiomodulation
Orthodontic treatment
Malocclusion
OrthoPulse™
Invisalign
Lead sponsor: Biolux Research Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-03
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Rate of tooth movement
timeFrame: From date of enrolment until the date of completion of the last Invisalign aligner, assessed every 4-6 weeks up to 2 years
Secondary outcomes:
measure: Length of treatment time
timeFrame: From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years
measure: Effect of photobiomodulation on external apical root resorption
timeFrame: From date of enrolment until the date of completion of the last Invisalign aligner, assessed up to 2 years
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Dickerson Orthodontics
state: Arizona
city: Maple Grove
country: United States
facility: Kottemann Orthodontics
state: Minnesota
city: Henderson
country: United States
facility: Chenin Orthodontics
state: Nevada
city: Oklahoma City
country: United States
facility: Orthodontic Associates
state: Oklahoma
Study officials:
affiliation: Biolux Research
name: Peter Brawn, DDS
role: STUDY_DIRECTOR
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