NCT02376829

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2021

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 6, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

6.7 years

First QC Date

February 11, 2015

Results QC Date

February 28, 2023

Last Update Submit

May 2, 2023

Conditions

Malocclusion

Keywords

OrthodonticOrthodontic TreatmentClear AlignersMalocclusion

Outcome Measures

Primary Outcomes (1)

  • 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).

    End of Class II Correction up to 18 months

Secondary Outcomes (3)

  • Length of Treatment Time

    End of Treatment approximately 2 years

  • Patient Quality of Life Questionnaire Throughout Treatment

    End of Treatment approximately 2 years

  • Doctor Survey for Satisfaction With Treatment Outcomes

    End of Treatment approximately 2 years

Study Arms (1)

The Invisalign System

EXPERIMENTAL

Class II correction of malocclusions

Device: Invisalign System

Interventions

Invisalign SystemDEVICE

The Invisalign® System is indicated for the alignment of teeth during orthodontic treatment of malocclusion

The Invisalign System

Eligibility Criteria

Age11 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Dr. Gary Brigham

Scottsdale, Arizona, 85260, United States

Location

Dr. Donna Galante

Rocklin, California, 95765, United States

Location

Dr. Mark Holt

Roseville, California, 95661, United States

Location

Dr. Ray Kubisch and Dr. Drew Ferris

Santa Barbara, California, 93105, United States

Location

Dr. Sandra Selnick

Ellicott City, Maryland, 21042, United States

Location

Dr. Regina Blevins

Inver Grove Heights, Minnesota, 55076, United States

Location

Dr. William Kottemann

Maple Grove, Minnesota, 55369, United States

Location

Dr. Barry Glaser

Cortlandt Manor, New York, 10567, United States

Location

Dr. Sam Daher

Vancouver, British Columbia, Canada

Location

Dr. Sandra Tai

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Sherri Wilson-Lopes
Organization
Align Technology Inc
swilson@aligntech.com
408-470-1032

Study Officials

  • Sherri Wilson-Lopes

    Align Technology, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2015

First Posted

March 3, 2015

Study Start

March 1, 2015

Primary Completion

November 23, 2021

Study Completion

November 23, 2021

Last Updated

May 6, 2023

Results First Posted

May 6, 2023

Record last verified: 2023-05

Locations

CA(2)US(8)