NCT02550938

Primer Aligner Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Align Technology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To demonstrate that a primer aligner product can achieve similar results to the currently marketed product.

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	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 a defined period of time , 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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2015-09-16
• Last updated: 2021-02-03
• Results posted: 2021-02-03

Locations

19 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study