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Class II Correction Study Using the Invisalign System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376829
Recruitment Status : Active, not recruiting
First Posted : March 3, 2015
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Align Technology, Inc.

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

Condition or disease Intervention/treatment Phase
Malocclusion Device: Invisalign System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Class II Correction Study Using the Invisalign System
Study Start Date : March 2015
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

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




Primary Outcome Measures :
  1. Rate of tooth movement at the end of Class II correction. [ Time Frame: End of Class II Correction approximately 9 months to 1 year ]

Secondary Outcome Measures :
  1. Length of treatment time [ Time Frame: End of Treatment approximately 2 years ]
  2. Patient quality of life questionnaire throughout treatment [ Time Frame: End of Treatment approximately 2 years ]
  3. Doctor survey for satisfaction with treatment outcomes [ Time Frame: End of Treatment approximately 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376829


Locations
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United States, Arizona
Dr. Gary Brigham
Scottsdale, Arizona, United States, 85260
United States, California
Dr. Donna Galante
Rocklin, California, United States, 95765
Dr. Mark Holt
Roseville, California, United States, 95661
Dr. Ray Kubisch and Dr. Drew Ferris
Santa Barbara, California, United States, 93105
United States, Maryland
Dr. Sandra Selnick
Ellicott City, Maryland, United States, 21042
United States, Minnesota
Dr. Regina Blevins
Inver Grove Heights, Minnesota, United States, 55076
Dr. William Kottemann
Maple Grove, Minnesota, United States, 55369
United States, New York
Dr. Barry Glaser
Cortlandt Manor, New York, United States, 10567
Canada, British Columbia
Dr. Sam Daher
Vancouver, British Columbia, Canada
Dr. Sandra Tai
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Align Technology, Inc.
Investigators
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Study Director: Sherri Wilson-Lopes Align Technology, Inc.
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Responsible Party: Align Technology, Inc.
ClinicalTrials.gov Identifier: NCT02376829    
Other Study ID Numbers: MRF-002
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Align Technology, Inc.:
Orthodontic
Orthodontic Treatment
Clear Aligners
Malocclusion
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases