Clinical trial NCT03202355: The Effect of OrthoPulse Photobiomodulation on the Rate of Tooth Movement During Alignment With Fixed Appliances
Official title: The Effect of OrthoPulse Photobiomodulation on the Rate of Tooth Movement During Alignment With Fixed Appliances
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Malocclusion
Keywords: Alignment phase
Photobiomodulation
Orthodontic treatment
Malocclusion
OrthoPulse™
Lead sponsor: Biolux Research Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-28
Enrollment: 10
Sex: ALL
Minimum age (years): 11
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm, parallel, open-label, non-randomized, controlled, private practice study designed to evaluate the intended purposes of the investigation.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine efficacy of OrthoPulse photobiomodulation on the rate of tooth movement during alignment for Subjects receiving fixed appliance orthodontic treatment.


Eligibility criteria: Inclusion Criteria:

* Presence of permanent dentition
* Eligible and scheduled for full-mouth, fixed-appliance orthodontic treatment
* Moderate to severe crowding (LII ≥ 3 mm), with no labio-lingually displaced teeth
* Class I or Class II malocclusion by ½ cusp or less
* Non-extraction in both arches
* Age 11-60
* Good oral hygiene
* Non-smoker; non-use of chewing tobacco

Exclusion Criteria:

* Subject is currently enrolled in another clinical study
* Subject decided on Invisalign rather than braces
* Periodontally involved teeth
* Use of bisphosphonates (osteoporosis drugs) during the study
* Subject plans to relocate over the treatment period
* Spaces between anterior teeth
* Subject has dental implants or an implanted prosthesis
* Sponsor employees, the Investigator and staff, as well as their immediate family members

Primary outcomes:
measure: Rate of tooth movement in OrthoPulse treated and non-OrthoPulse treated patients
timeFrame: From start of treatment until Little's Irregularity Index (LII) reaches less than approximately 2 mm but greater than 0 mm, no more than 6 months after the start of treatment.
Secondary outcomes:
measure: Effect of OrthoPulse PBM on external apical root resorption (EARR)
timeFrame: 6 months after the start of orthodontic treatment
measure: Risk of OrthoPulse PBM to the patient.
timeFrame: 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
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Dickerson Orthodontics
state: Arizona
city: Peoria
country: United States
facility: Dickerson Orthodontics
state: Arizona
city: Phoenix
country: United States
facility: Dickerson Orthodontics
state: Arizona
Study officials:
affiliation: Biolux Research Holdings, Inc.
name: Peter Brawn, DDS
role: STUDY_DIRECTOR
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