Class II Correction Study Using the Invisalign System

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
The Invisalign System	Invisalign System	Class II correction of malocclusions

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Length of Treatment Time	End of Treatment approximately 2 years	This is the total treatment length of time that subjects took (in days) to complete Invisalign system treatment
Doctor Survey for Satisfaction With Treatment Outcomes	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 .
Patient Quality of Life Questionnaire Throughout Treatment	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.

Locations (10): Dr. Mark Holt
🇺🇸
Roseville, California, United States
Dr. Ray Kubisch and Dr. Drew Ferris
🇺🇸
Santa Barbara, California, United States
Dr. William Kottemann
🇺🇸
Maple Grove, Minnesota, United States
Dr. Donna Galante
🇺🇸
Rocklin, California, United States
Dr. Barry Glaser
🇺🇸
Cortlandt Manor, New York, United States
Dr. Sandra Selnick
🇺🇸
Ellicott City, Maryland, United States
Dr. Gary Brigham
🇺🇸
Scottsdale, Arizona, United States
Dr. Regina Blevins
🇺🇸
Inver Grove Heights, Minnesota, United States
Dr. Sandra Tai
🇨🇦
Vancouver, British Columbia, Canada
Dr. Sam Daher
🇨🇦
Vancouver, British Columbia, Canada