One Week Aligner Evaluation

Malocclusion Clinical Trial

Official title:

One Week Aligner Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603289
• Other study ID #: CSP-300313-00
• Status: Completed
• Start date: September 2015
• Est. completion date: August 2020

Study information

• Verified date: October 2020
• Source: Align Technology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.

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. The aligners are designed to optimally move each tooth at a speed that follows physiologic principles. The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: August 2020
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subject must have fully erupted dentition except for 2nd and 3rd molars

• For Teen treatment group, subjects ages <17 years of age

• For Adult treatment group, subjects =17 years of age

Exclusion Criteria:

• Subject has undergone any accelerated orthodontic treatment prior to or during treatment as part of this study

• Subject with active caries

• Subject with periodontal disease

• Subject with TMD symptoms

• Subject has known allergy to latex or plastic

• Subjects who are pregnant or will become pregnant during treatment

Related Conditions & MeSH terms

• Malocclusion

Intervention

Device:
• Invisalign

Locations

Country	Name	City	State
Canada	Dr. Bart Iwasiuk	Brampton	Ontario
United States	Dr. Thomas Everett	Burnsville	Minnesota
United States	Dr. Vincent D'Ascoli	Carson City	Nevada
United States	Dr. Justin Wild	Eden Prairie	Minnesota
United States	Dr. Jeff Mastroianni	Glen Carbon	Illinois
United States	Dr. David Chenin	Henderson	Nevada
United States	Dr. Regina Blevins	Inver Grove Heights	Minnesota
United States	Dr. Thomas Marcel	Livermore	California
United States	Dr. Anil Idiculla	Lone Tree	Colorado
United States	Dr. Mark Perelmuter	Louisville	Kentucky
United States	Dr. Zvi Kennet	Macomb	Michigan
United States	Dr. William Kottemann	Maple Grove	Minnesota
United States	Dr. Carlyn Phucas	Marlton	New Jersey
United States	Dr. Ryan Caudill	Merritt Island	Florida
United States	Dr. David Paquette	Mooresville	North Carolina
United States	Dr. Mary Cooke	Napa	California
United States	Dr. Brian Amy	Oklahoma City	Oklahoma
United States	Dr. Sean Holliday	Pearl City	Hawaii
United States	Dr. James Crouse	Salisbury	Maryland
United States	Dr. Bella Shen Garnett	San Francisco	California
United States	Align Technology, Inc.	San Jose	California
United States	Dr. Robery Van den Berg	San Ramon	California
United States	Dr. Clark Colville	Seguin	Texas
United States	Dr. William Gierie	Wilmington	North Carolina

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	Planned to Final Tooth Position	Test vs Historical Control Group	Through study completion, an average of 2 years
Secondary	Treatment time	Length of treatment	Through study completion, an average of 2 years
Secondary	Subject Quality of Life	Assessment of QoL	Through study completion, an average of 2 years