Clinical trial NCT02603289: One Week Aligner Evaluation
Official title: One Week Aligner Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malocclusion
Lead sponsor: Align Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-11
Enrollment: 287
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Invisalign patients from selected pool of investigators

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.

Eligibility criteria: 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

Primary outcomes:
measure: Planned to Final Tooth Position
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Treatment time
timeFrame: Through study completion, an average of 2 years
measure: Subject Quality of Life
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Livermore
country: United States
facility: Dr. Thomas Marcel
state: California
city: Napa
country: United States
facility: Dr. Mary Cooke
state: California
city: San Francisco
country: United States
facility: Dr. Bella Shen Garnett
state: California
city: San Jose
country: United States
facility: Align Technology, Inc.
state: California
city: San Ramon
country: United States
facility: Dr. Robery Van den Berg
state: California
city: Lone Tree
country: United States
facility: Dr. Anil Idiculla
state: Colorado
city: Merritt Island
country: United States
facility: Dr. Ryan Caudill
state: Florida
city: Pearl City
country: United States
facility: Dr. Sean Holliday
state: Hawaii
city: Glen Carbon
country: United States
facility: Dr. Jeff Mastroianni
state: Illinois
city: Louisville
country: United States
facility: Dr. Mark Perelmuter
state: Kentucky
city: Salisbury
country: United States
facility: Dr. James Crouse
state: Maryland
city: Macomb
country: United States
facility: Dr. Zvi Kennet
state: Michigan
city: Burnsville
country: United States
facility: Dr. Thomas Everett
state: Minnesota
city: Eden Prairie
country: United States
facility: Dr. Justin Wild
state: Minnesota
city: Inver Grove Heights
country: United States
facility: Dr. Regina Blevins
state: Minnesota
city: Maple Grove
country: United States
facility: Dr. William Kottemann
state: Minnesota
city: Carson City
country: United States
facility: Dr. Vincent D'Ascoli
state: Nevada
city: Henderson
country: United States
facility: Dr. David Chenin
state: Nevada
city: Marlton
country: United States
facility: Dr. Carlyn Phucas
state: New Jersey
city: Mooresville
country: United States
facility: Dr. David Paquette
state: North Carolina
city: Wilmington
country: United States
facility: Dr. William Gierie
state: North Carolina
city: Oklahoma City
country: United States
facility: Dr. Brian Amy
state: Oklahoma
city: Seguin
country: United States
facility: Dr. Clark Colville
state: Texas
city: Brampton
country: Canada
facility: Dr. Bart Iwasiuk
state: Ontario
Study officials:
References: