NCT02267811

The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement

The Effect of OrthoPulse™ on the Rate of Orthodontic Tooth Movement During Alignment With Fixed Appliances

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Biolux Research Holdings, Inc. · Industry
• Sex: All
• Age: 11 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malocclusion

Interventions

Type	Name	Description
OTHER	Orthodontic Treatment	Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
DEVICE	OrthoPulse™	Participants carry out daily OrthoPulse™ treatments at home.

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2014-10-20
• Last updated: 2019-05-21
• Results posted: 2019-05-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study