OrthoPulse 2.0 and 2.1 Feasibility Evaluation

Not Applicable

• Conditions: Malocclusion
• Interventions: Device: OrthoPulse 2.0; Device: OrthoPulse 2.1; Device: Fixed Orthodontic Appliances (Braces); Device: Invisalign 3.5 Day Wear

• Registration Number: NCT03683017
• Lead Sponsor: Biolux Research Holdings, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-22
• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-25
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-22
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I-OP2.0	OrthoPulse 2.0	Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.
F-OP2.0	Fixed Orthodontic Appliances (Braces)	Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.
I-OP2.1	OrthoPulse 2.1	Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.1 device.
I-OP2.0	Invisalign 3.5 Day Wear	Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.
I-OP2.1	Invisalign 3.5 Day Wear	Patients receive Invisalign orthodontic treatment, with 3.5 day Aligner changes, by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.1 device.
F-OP2.0	OrthoPulse 2.0	Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Patients receive OrthoPulse 2.0 device.

Primary Outcome Measures

Name	Time	Method
Feedback on general experience	Through Study Completion, approx. 2 years	Assess doctor and patient feedback on the general experience with OrthoPulse 2.0 and OrthoPulse 2.1 as measured in the electronic data capture system.
Feedback on clinical performance	Through Study Completion, approx. 2 years	Assess doctor subjective and objective feedback on the clinical performance of OrthoPulse 2.0 and OrthoPulse 2.1 as measured in the electronic data capture system.
Adverse events	Through Study Completion, approx. 2 years	Confirm initial safety of OrthoPulse 2.0 and OrthoPulse 2.1

Trial Locations

Locations (4)

Bella Smile; 🇺🇸 San Francisco, California, United States

Dickerson Orthodontics; 🇺🇸 Scottsdale, Arizona, United States

Sphinx Orthodontics; 🇨🇦 Edmonton, Alberta, Canada

Chenin Orthodontics; 🇺🇸 Henderson, Nevada, United States