Class II Correction Study Using the Invisalign System

Malocclusion Clinical Trial

Official title:

Class II Correction Study Using the Invisalign System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376829
• Other study ID #: MRF-002
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: November 23, 2021

Study information

• Verified date: May 2023
• Source: Align Technology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: November 23, 2021
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 19 Years

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

Related Conditions & MeSH terms

• Malocclusion

Intervention

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

Locations

Country	Name	City	State
Canada	Dr. Sam Daher	Vancouver	British Columbia
Canada	Dr. Sandra Tai	Vancouver	British Columbia
United States	Dr. Barry Glaser	Cortlandt Manor	New York
United States	Dr. Sandra Selnick	Ellicott City	Maryland
United States	Dr. Regina Blevins	Inver Grove Heights	Minnesota
United States	Dr. William Kottemann	Maple Grove	Minnesota
United States	Dr. Donna Galante	Rocklin	California
United States	Dr. Mark Holt	Roseville	California
United States	Dr. Ray Kubisch and Dr. Drew Ferris	Santa Barbara	California
United States	Dr. Gary Brigham	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Align Technology, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of Treatment Time	This is the total treatment length of time that subjects took (in days) to complete Invisalign system treatment	End of Treatment approximately 2 years
Secondary	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.	End of Treatment approximately 2 years
Secondary	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 .	End of Treatment approximately 2 years