Clinical Trial: Class II Correction Study Using the Invisalign System
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Class II Correction Study Using the Invisalign System
Brief Summary: To demonstrate that growing teenagers which present up to full cusp Class II malocclusions can be treated using the Invisalign System.
Detailed Summary: 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.
Sponsor: Align Technology, Inc.
Current Primary Outcome: Rate of tooth movement at the end of Class II correction. [ Time Frame: End of Class II Correction approximately 9 months to 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Length of treatment time [ Time Frame: End of Treatment approximately 2 years ]
- Patient quality of life questionnaire throughout treatment [ Time Frame: End of Treatment approximately 2 years ]
- Doctor survey for satisfaction with treatment outcomes [ Time Frame: End of Treatment approximately 2 years ]
Original Secondary Outcome: Same as current
Information By: Align Technology, Inc.
Dates:
Date Received: February 11, 2015
Date Started: March 2015
Date Completion: February 2020
Last Updated: January 23, 2017
Last Verified: January 2017
