Clinical trial NCT02267811: The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement
Official title: The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement During Alignment With Fixed Appliances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: Photobiomodulation
Orthodontic treatment
Malocclusion
OrthoPulse™
Lead sponsor: Biolux Research Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 33
Sex: ALL
Minimum age (years): 11
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open label study is designed to evaluate the ability of OrthoPulse™ to safely and effectively increase the rate of orthodontic tooth movement with fixed appliances.

Detailed description: The primary aim of this study is to determine if daily OrthoPulse™ use affects the rate of orthodontic tooth movement during alignment with fixed appliances in the mandibular arch.

The secondary aim of this study is to determine whether patients treated with OrthoPulse demonstrate root resorption beyond what is commonly expected during orthodontic treatment.

The study also aims to collect confirmatory evidence on the safety of the device.

Eligibility criteria: Inclusion Criteria:

* Eligible and scheduled for full mouth fixed orthodontic treatment
* Moderate to severe crowding (LII ≥ 3 mm), with no labio-lingually displaced teeth
* Class I or Class II by 1/2 cusp or less
* Non-extraction in both arches
* Age 11- 60
* Good oral hygiene
* Non-smokerInclud

Exclusion Criteria:

* Pregnant females
* Patient is currently enrolled in another clinical study
* Patient decided on Invisalign® rather than braces
* Periodontally involved teeth
* Use of bisphosphonates (osteoporosis drugs) during the study
* Patient plans to move over the treatment period
* Spaces between anterior teeth

Primary outcomes:
measure: Evaluation of Whether OrthoPulse Use Affects the Rate of Orthodontic Tooth Movement During Full Mouth Fixed Orthodontic Treatment
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.
Secondary outcomes:
measure: Safety Evidence of OrthoPulse™ Use
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.
measure: Degree of External Apical Root Resorption (EARR)
timeFrame: Assessed at six (6) months or later after starting treatment, up to two (2) years.
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Stone Oak Orthodontics
state: Texas
Study officials:
affiliation: Biolux Research
name: Peter Brawn, DDS
role: STUDY_DIRECTOR
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