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Class II Correction Study Using the Invisalign System

Primary Purpose

Malocclusion

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Invisalign System
Sponsored by
Align Technology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring Orthodontic, Orthodontic Treatment, Clear Aligners, Malocclusion

Eligibility Criteria

11 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dr. Gary Brigham
  • Dr. Donna Galante
  • Dr. Mark Holt
  • Dr. Ray Kubisch and Dr. Drew Ferris
  • Dr. Sandra Selnick
  • Dr. Regina Blevins
  • Dr. William Kottemann
  • Dr. Barry Glaser
  • Dr. Sam Daher
  • Dr. Sandra Tai

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The Invisalign System

Arm Description

Class II correction of malocclusions

Outcomes

Primary Outcome Measures

Rate of Tooth Movement at the End of Class II Correction.
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).

Secondary Outcome Measures

Length of Treatment Time
This is the total treatment length of time that subjects took (in days) to complete Invisalign system treatment
Patient Quality of Life Questionnaire Throughout Treatment
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.
Doctor Survey for Satisfaction With Treatment Outcomes
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 .

Full Information

First Posted
February 11, 2015
Last Updated
May 2, 2023
Sponsor
Align Technology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02376829
Brief Title
Class II Correction Study Using the Invisalign System
Official Title
Class II Correction Study Using the Invisalign System
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
November 23, 2021 (Actual)
Study Completion Date
November 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Align Technology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
Orthodontic, Orthodontic Treatment, Clear Aligners, Malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Invisalign System
Arm Type
Experimental
Arm Description
Class II correction of malocclusions
Intervention Type
Device
Intervention Name(s)
Invisalign System
Intervention Description
The Invisalign® System is indicated for the alignment of teeth during orthodontic treatment of malocclusion
Primary Outcome Measure Information:
Title
Rate of Tooth Movement at the End of Class II Correction.
Description
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).
Time Frame
End of Class II Correction up to 18 months
Secondary Outcome Measure Information:
Title
Length of Treatment Time
Description
This is the total treatment length of time that subjects took (in days) to complete Invisalign system treatment
Time Frame
End of Treatment approximately 2 years
Title
Patient Quality of Life Questionnaire Throughout Treatment
Description
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.
Time Frame
End of Treatment approximately 2 years
Title
Doctor Survey for Satisfaction With Treatment Outcomes
Description
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 .
Time Frame
End of Treatment approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherri Wilson-Lopes
Organizational Affiliation
Align Technology, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Gary Brigham
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Dr. Donna Galante
City
Rocklin
State/Province
California
ZIP/Postal Code
95765
Country
United States
Facility Name
Dr. Mark Holt
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Dr. Ray Kubisch and Dr. Drew Ferris
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Dr. Sandra Selnick
City
Ellicott City
State/Province
Maryland
ZIP/Postal Code
21042
Country
United States
Facility Name
Dr. Regina Blevins
City
Inver Grove Heights
State/Province
Minnesota
ZIP/Postal Code
55076
Country
United States
Facility Name
Dr. William Kottemann
City
Maple Grove
State/Province
Minnesota
ZIP/Postal Code
55369
Country
United States
Facility Name
Dr. Barry Glaser
City
Cortlandt Manor
State/Province
New York
ZIP/Postal Code
10567
Country
United States
Facility Name
Dr. Sam Daher
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Dr. Sandra Tai
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

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Class II Correction Study Using the Invisalign System

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