One Week Aligner Evaluation

NCT ID: NCT02603289

Last Updated: 2020-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

287 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2020-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Malocclusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Teen

\< 17 years of age

Invisalign

Intervention Type DEVICE

Adult

17 years of age or older

Invisalign

Intervention Type DEVICE

Adult with Primer Aligners

17 years of age or older This group will get Primer Aligners

Invisalign

Intervention Type DEVICE

Interventions

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Invisalign

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Align Technology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dr. Thomas Marcel

Livermore, California, United States

Site Status

Dr. Mary Cooke

Napa, California, United States

Site Status

Dr. Bella Shen Garnett

San Francisco, California, United States

Site Status

Align Technology, Inc.

San Jose, California, United States

Site Status

Dr. Robery Van den Berg

San Ramon, California, United States

Site Status

Dr. Anil Idiculla

Lone Tree, Colorado, United States

Site Status

Dr. Ryan Caudill

Merritt Island, Florida, United States

Site Status

Dr. Sean Holliday

Pearl City, Hawaii, United States

Site Status

Dr. Jeff Mastroianni

Glen Carbon, Illinois, United States

Site Status

Dr. Mark Perelmuter

Louisville, Kentucky, United States

Site Status

Dr. James Crouse

Salisbury, Maryland, United States

Site Status

Dr. Zvi Kennet

Macomb, Michigan, United States

Site Status

Dr. Thomas Everett

Burnsville, Minnesota, United States

Site Status

Dr. Justin Wild

Eden Prairie, Minnesota, United States

Site Status

Dr. Regina Blevins

Inver Grove Heights, Minnesota, United States

Site Status

Dr. William Kottemann

Maple Grove, Minnesota, United States

Site Status

Dr. Vincent D'Ascoli

Carson City, Nevada, United States

Site Status

Dr. David Chenin

Henderson, Nevada, United States

Site Status

Dr. Carlyn Phucas

Marlton, New Jersey, United States

Site Status

Dr. David Paquette

Mooresville, North Carolina, United States

Site Status

Dr. William Gierie

Wilmington, North Carolina, United States

Site Status

Dr. Brian Amy

Oklahoma City, Oklahoma, United States

Site Status

Dr. Clark Colville

Seguin, Texas, United States

Site Status

Dr. Bart Iwasiuk

Brampton, Ontario, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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CSP-300313-00

Identifier Type: -

Identifier Source: org_study_id

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