Clinical trial NCT03683017: OrthoPulse 2.0 and 2.1 Feasibility Evaluation
Official title: OrthoPulse 2.0 and 2.1 Product Evaluation and Assessing Clinical Effectiveness: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malocclusion
Keywords: Malocclusion
Photobiomodulation
Biolux
OrthoPulse
Low-level laser therapy
Orthodontics
Lead sponsor: Biolux Research Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-25
Enrollment: 35
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: OrthoPulse is a device that uses near-infrared light therapy in order to decrease orthodontic treatment time. The aim of this study is to evaluate OrthoPulse products modified with extended arrays, OrthoPulse 2.0 and OrthoPulse 2.1, and to assess their clinical effectiveness.


Eligibility criteria: Inclusion Criteria:

* Written Informed Consent must be obtained before any assessment is performed
* Patient must be 11 years of age or older; minors will only be included in the study with the consent of the Parent/Legal Authorized Representative (LAR)
* Presence of permanent dentition
* Eligible and scheduled for full mouth fixed orthodontic treatment or Invisalign
* Good oral hygiene
* Likely to be compliant to OrthoPulse 2.0 and 2.1 use, aligner wear and elastic wear
* Have a compatible iOS or Android device and are willing to download the OrthoPulse app for frequent automatic syncing of use data

Exclusion Criteria:

* Patient is currently enrolled in another clinical study
* Periodontally involved teeth, acute oral infection or periodontal disease
* Use of bisphosphonates (osteoporosis drugs) during the study
* Use of drugs that may cause photosensitivity
* History of photosensitivity
* History of poor oral hygiene, per the discretion of the Principal Investigator (PI)
* Epilepsy
* Patient plans to relocate over the treatment period
* Smoker or use of any tobacco containing products per the discretion of the PI

Primary outcomes:
measure: Feedback on general experience
timeFrame: Through Study Completion, approx. 2 years
measure: Feedback on clinical performance
timeFrame: Through Study Completion, approx. 2 years
measure: Adverse events
timeFrame: Through Study Completion, approx. 2 years
Secondary outcomes:
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
city: Scottsdale
country: United States
facility: Dickerson Orthodontics
state: Arizona
city: San Francisco
country: United States
facility: Bella Smile
state: California
city: Henderson
country: United States
facility: Chenin Orthodontics
state: Nevada
city: Edmonton
country: Canada
facility: Sphinx Orthodontics
state: Alberta
Study officials:
affiliation: Biolux Research Holdings, Inc.
name: Peter Brawn, DDS
role: STUDY_DIRECTOR
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