One Week Aligner Evaluation
- Conditions
- Malocclusion
- Interventions
- Device: Invisalign
- Registration Number
- NCT02603289
- Lead Sponsor
- Align Technology, Inc.
- Brief Summary
The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.
- 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. 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 287
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Adult with Primer Aligners Invisalign 17 years of age or older This group will get Primer Aligners Adult Invisalign 17 years of age or older Teen Invisalign \< 17 years of age
- Primary Outcome Measures
Name Time Method Planned to Final Tooth Position Through study completion, an average of 2 years Test vs Historical Control Group
- Secondary Outcome Measures
Name Time Method Treatment time Through study completion, an average of 2 years Length of treatment
Subject Quality of Life Through study completion, an average of 2 years Assessment of QoL
Trial Locations
- Locations (24)
Dr. Sean Holliday
🇺🇸Pearl City, Hawaii, United States
Dr. Mark Perelmuter
🇺🇸Louisville, Kentucky, United States
Dr. Ryan Caudill
🇺🇸Merritt Island, Florida, United States
Dr. Zvi Kennet
🇺🇸Macomb, Michigan, United States
Dr. Anil Idiculla
🇺🇸Lone Tree, Colorado, United States
Dr. William Gierie
🇺🇸Wilmington, North Carolina, United States
Dr. Clark Colville
🇺🇸Seguin, Texas, United States
Dr. Thomas Marcel
🇺🇸Livermore, California, United States
Dr. David Chenin
🇺🇸Henderson, Nevada, United States
Dr. Carlyn Phucas
🇺🇸Marlton, New Jersey, United States
Dr. Bart Iwasiuk
🇨🇦Brampton, Ontario, Canada
Dr. Brian Amy
🇺🇸Oklahoma City, Oklahoma, United States
Dr. Robery Van den Berg
🇺🇸San Ramon, California, United States
Dr. Mary Cooke
🇺🇸Napa, California, United States
Align Technology, Inc.
🇺🇸San Jose, California, United States
Dr. Jeff Mastroianni
🇺🇸Glen Carbon, Illinois, United States
Dr. James Crouse
🇺🇸Salisbury, Maryland, United States
Dr. Thomas Everett
🇺🇸Burnsville, Minnesota, United States
Dr. Justin Wild
🇺🇸Eden Prairie, Minnesota, United States
Dr. William Kottemann
🇺🇸Maple Grove, Minnesota, United States
Dr. Regina Blevins
🇺🇸Inver Grove Heights, Minnesota, United States
Dr. Bella Shen Garnett
🇺🇸San Francisco, California, United States
Dr. Vincent D'Ascoli
🇺🇸Carson City, Nevada, United States
Dr. David Paquette
🇺🇸Mooresville, North Carolina, United States