NCT03683017

OrthoPulse 2.0 and 2.1 Feasibility Evaluation

OrthoPulse 2.0 and 2.1 Product Evaluation and Assessing Clinical Effectiveness: A Feasibility Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Biolux Research Holdings, Inc. · Industry
• Sex: All
• Age: 11 Years
• Healthy volunteers: Accepted

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.

Conditions

• Malocclusion

Interventions

Type	Name	Description
DEVICE	OrthoPulse 2.0	Patients are given OrthoPulse 2.0, an extended OrthoPulse device with no zone control (ability for doctor to control treatment regions). Patients complete 10 minute treatments (5 minutes each arch) every day.
DEVICE	OrthoPulse 2.1	Patients are given OrthoPulse 2.1, an extended OrthoPulse device with zone control (ability for doctor to control treatment regions). Patients complete 10 minute treatments (5 minutes each arch) every day.
DEVICE	Invisalign 3.5 Day Wear	Patients are are fitted with sets of clear orthodontic Aligners by a qualified Principal Investigator (PI) using a ClinCheck plan by Align Technology. Aligners are worn for approximately 22 hours a day, and switched every 3.5 days.
DEVICE	Fixed Orthodontic Appliances (Braces)	Patients are fitted with a set of brackets and wires, as per standard orthodontic treatment by a qualified Principal Investigator (PI).

Timeline

• Start date: 2017-12-22
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2018-09-25
• Last updated: 2019-10-22

Locations

7 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study