NCT02954133

The Effect of OrthoPulse™ Photobiomodulation on Tooth Movement and Treatment Time When Used With Invisalign Treatment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Biolux Research Holdings, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to determine if, and to what degree photobiomodulation treatment with OrthoPulse has an effect on the rate of tooth movement during alignment for patients receiving Invisalign orthodontic aligner treatment.

Conditions

• Malocclusion

Interventions

Type	Name	Description
DEVICE	Invisalign (7 day)	Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 7 days.
DEVICE	Invisalign (5 day)	Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 5 days.
DEVICE	OrthoPulse	Daily 10 minute (5 minutes per arch) OrthoPulse treatments are administered at home.
DEVICE	Invisalign (3.5 day)	Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 3.5 days.

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2016-11-03
• Last updated: 2019-01-15

Locations

4 sites across 1 country: United States