Class II Correction Study Using the Invisalign System

May 2, 2023 updated by: Align Technology, Inc.
To demonstrate that growing teenagers which present up to full cusp Class II malocclusions can be treated using the Invisalign System.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Dr. Sam Daher
      • Vancouver, British Columbia, Canada
        • Dr. Sandra Tai
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Dr. Gary Brigham
    • California
      • Rocklin, California, United States, 95765
        • Dr. Donna Galante
      • Roseville, California, United States, 95661
        • Dr. Mark Holt
      • Santa Barbara, California, United States, 93105
        • Dr. Ray Kubisch and Dr. Drew Ferris
    • Maryland
      • Ellicott City, Maryland, United States, 21042
        • Dr. Sandra Selnick
    • Minnesota
      • Inver Grove Heights, Minnesota, United States, 55076
        • Dr. Regina Blevins
      • Maple Grove, Minnesota, United States, 55369
        • Dr. William Kottemann
    • New York
      • Cortlandt Manor, New York, United States, 10567
        • Dr. Barry Glaser

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Subject must have fully erupted dentition excluding 2nd and 3rd molars
  • Age range 11-19 years old
  • Subject that requires bilateral Class II correction and must require at least 3mm of correction as measured by first molar relationship

Exclusion Criteria:

  • Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)
  • Subject who has spaces between adjacent teeth larger than 3mm
  • Subject with active caries
  • Subject with periodontal disease
  • Subject does not have at least 1st molar fully captured in PVS (polyvinyl siloxane material ) impression or intraoral scan.
  • Subject with TMD (Temporomandibular joint dysfunction) symptoms
  • Subject has undergone pre-treatment with any orthodontic appliance (any previous treatment prior to study)
  • Subject has known allergy to latex and plastic
  • Subjects who are pregnant or will become pregnant during treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Invisalign System
Class II correction of malocclusions
Device: Invisalign System
The Invisalign® System is indicated for the alignment of teeth during orthodontic treatment of malocclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Tooth Movement at the End of Class II Correction.
Time Frame: End of Class II Correction up to 18 months
The primary objective will be met through demonstrating that the velocity of Invisalign with MRF overjet correction is non-inferior to the published rates of Dynamax (0.42mm/month).
End of Class II Correction up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Treatment Time
Time Frame: End of Treatment approximately 2 years
This is the total treatment length of time that subjects took (in days) to complete Invisalign system treatment
End of Treatment approximately 2 years
Patient Quality of Life Questionnaire Throughout Treatment
Time Frame: End of Treatment approximately 2 years
As part of the secondary objective, subject perception was assessed through analysis of case report forms. Case report form analysis of the Quality of Life forms was conducted from the subjects in both the Clinical Study and Continued Access Clinical Study. Subjects were asked to rate their orthodontic experience throughout the course of the study, with options 1(very difficult), 2 (difficult), 3 (average), 4 (easy), and 5 (very easy) as the ratings.
End of Treatment approximately 2 years
Doctor Survey for Satisfaction With Treatment Outcomes
Time Frame: End of Treatment approximately 2 years
Doctors filled out a Doctor Survey with a scale rating of 1 (very difficult) to 5 (very easy) on how easy the product was to use and their satisfaction with the product. A higher score on the scale meant a better satisfaction experience .
End of Treatment approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Align Technology, Inc.

Investigators

  • Study Director: Sherri Wilson-Lopes, Align Technology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

November 23, 2021

Study Completion (Actual)

November 23, 2021

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRF-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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