NCT02376829

Class II Correction Study Using the Invisalign System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Align Technology, Inc. · Industry
• Sex: All
• Age: 11 Years – 19 Years
• Healthy volunteers: Accepted

Summary

To demonstrate that growing teenagers which present up to full cusp Class II malocclusions can be treated using the Invisalign System.

Detailed description

The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.

Conditions

• Malocclusion

Interventions

Type	Name	Description
DEVICE	Invisalign System	The Invisalign® System is indicated for the alignment of teeth during orthodontic treatment of malocclusion

Timeline

• Start date: 2015-03-01
• Primary completion: 2021-11-23
• Completion: 2021-11-23
• First posted: 2015-03-03
• Last updated: 2023-05-06
• Results posted: 2023-05-06

Locations

10 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study