| Registry | NCT02603289 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 287 (Actual) |
| Sponsor | Align Technology, Inc. (Industry) |
| Conditions | Malocclusion |
| Interventions | Invisalign (Device) |
| Dates | start 2015-09-01, primary completion 2018-11-01, completion 2020-08-01, first posted 2015-11-11, last updated 2020-10-20 |
| Locations | 24 sites in United States, Canada |
Related Papers Related Patents Related Grants Related Experts
All trials for Malocclusion All trials of Invisalign
The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Teen | Device: Invisalign | < 17 years of age | |
| Adult | Device: Invisalign | 17 years of age or older | |
| Adult with Primer Aligners | Device: Invisalign | 17 years of age or older This group will get Primer Aligners |
Sex: All, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Dr. Thomas Marcel | Livermore, California | United States | |
| Dr. Mary Cooke | Napa, California | 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. Anil Idiculla | Lone Tree, Colorado | United States | |
| Dr. Ryan Caudill | Merritt Island, Florida | United States | |
| Dr. Sean Holliday | Pearl City, Hawaii | United States | |
| Dr. Jeff Mastroianni | Glen Carbon, Illinois | United States | |
| Dr. Mark Perelmuter | Louisville, Kentucky | United States | |
| Dr. James Crouse | Salisbury, Maryland | United States | |
| Dr. Zvi Kennet | Macomb, Michigan | United States | |
| Dr. Thomas Everett | Burnsville, Minnesota | United States | |
| Dr. Justin Wild | Eden Prairie, Minnesota | United States | |
| Dr. Regina Blevins | Inver Grove Heights, Minnesota | United States | |
| Dr. William Kottemann | Maple Grove, Minnesota | United States | |
| Dr. Vincent D'Ascoli | Carson City, Nevada | United States | |
| Dr. David Chenin | Henderson, Nevada | United States | |
| Dr. Carlyn Phucas | Marlton, New Jersey | United States | |
| Dr. David Paquette | Mooresville, North Carolina | United States | |
| Dr. William Gierie | Wilmington, North Carolina | United States | |
| Dr. Brian Amy | Oklahoma City, Oklahoma | United States | |
| Dr. Clark Colville | Seguin, Texas | United States | |
| Dr. Bart Iwasiuk | Brampton, Ontario | Canada |