One Week Aligner Evaluation
1 other identifier
observational
287
2 countries
24
Brief Summary
The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Longer than P75 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 10, 2015
CompletedFirst Posted
Study publicly available on registry
November 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedOctober 20, 2020
October 1, 2020
3.2 years
November 10, 2015
October 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Planned to Final Tooth Position
Test vs Historical Control Group
Through study completion, an average of 2 years
Secondary Outcomes (2)
Treatment time
Through study completion, an average of 2 years
Subject Quality of Life
Through study completion, an average of 2 years
Study Arms (3)
Teen
\< 17 years of age
Adult
17 years of age or older
Adult with Primer Aligners
17 years of age or older This group will get Primer Aligners
Interventions
Eligibility Criteria
Invisalign patients from selected pool of investigators
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Dr. Thomas Marcel
Livermore, California, 94550, United States
Dr. Mary Cooke
Napa, California, 94558, United States
Dr. Bella Shen Garnett
San Francisco, California, 94118, United States
Align Technology, Inc.
San Jose, California, 95131, United States
Dr. Robery Van den Berg
San Ramon, California, 94583, United States
Dr. Anil Idiculla
Lone Tree, Colorado, 80124, United States
Dr. Ryan Caudill
Merritt Island, Florida, 32953, United States
Dr. Sean Holliday
Pearl City, Hawaii, 96782, United States
Dr. Jeff Mastroianni
Glen Carbon, Illinois, 62034, United States
Dr. Mark Perelmuter
Louisville, Kentucky, 40207, United States
Dr. James Crouse
Salisbury, Maryland, 21801, United States
Dr. Zvi Kennet
Macomb, Michigan, 48044, United States
Dr. Thomas Everett
Burnsville, Minnesota, 55306, United States
Dr. Justin Wild
Eden Prairie, Minnesota, 55344, United States
Dr. Regina Blevins
Inver Grove Heights, Minnesota, 55076, United States
Dr. William Kottemann
Maple Grove, Minnesota, 55369, United States
Dr. Vincent D'Ascoli
Carson City, Nevada, 89701, United States
Dr. David Chenin
Henderson, Nevada, 89052, United States
Dr. Carlyn Phucas
Marlton, New Jersey, 08053, United States
Dr. David Paquette
Mooresville, North Carolina, 28117, United States
Dr. William Gierie
Wilmington, North Carolina, 28405, United States
Dr. Brian Amy
Oklahoma City, Oklahoma, 73120, United States
Dr. Clark Colville
Seguin, Texas, 78155, United States
Dr. Bart Iwasiuk
Brampton, Ontario, L6Z-4N5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2015
First Posted
November 11, 2015
Study Start
September 1, 2015
Primary Completion
November 1, 2018
Study Completion
August 1, 2020
Last Updated
October 20, 2020
Record last verified: 2020-10