One Week Aligner Evaluation

October 19, 2020 updated by: Align Technology, Inc.
The purpose of this study is to demonstrate that changing aligners weekly provides similar results to changing aligners every two weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
287

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6Z-4N5
        • Dr. Bart Iwasiuk
  • United States
    • California
      • Livermore, California, United States, 94550
        • Dr. Thomas Marcel
      • Napa, California, United States, 94558
        • Dr. Mary Cooke
      • San Francisco, California, United States, 94118
        • Dr. Bella Shen Garnett
      • San Jose, California, United States, 95131
        • Align Technology, Inc.
      • San Ramon, California, United States, 94583
        • Dr. Robery Van den Berg
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Dr. Anil Idiculla
    • Florida
      • Merritt Island, Florida, United States, 32953
        • Dr. Ryan Caudill
    • Hawaii
      • Pearl City, Hawaii, United States, 96782
        • Dr. Sean Holliday
    • Illinois
      • Glen Carbon, Illinois, United States, 62034
        • Dr. Jeff Mastroianni
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Dr. Mark Perelmuter
    • Maryland
      • Salisbury, Maryland, United States, 21801
        • Dr. James Crouse
    • Michigan
      • Macomb, Michigan, United States, 48044
        • Dr. Zvi Kennet
    • Minnesota
      • Burnsville, Minnesota, United States, 55306
        • Dr. Thomas Everett
      • Eden Prairie, Minnesota, United States, 55344
        • Dr. Justin Wild
      • Inver Grove Heights, Minnesota, United States, 55076
        • Dr. Regina Blevins
      • Maple Grove, Minnesota, United States, 55369
        • Dr. William Kottemann
    • Nevada
      • Carson City, Nevada, United States, 89701
        • Dr. Vincent D'Ascoli
      • Henderson, Nevada, United States, 89052
        • Dr. David Chenin
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Dr. Carlyn Phucas
    • North Carolina
      • Mooresville, North Carolina, United States, 28117
        • Dr. David Paquette
      • Wilmington, North Carolina, United States, 28405
        • Dr. William Gierie
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Dr. Brian Amy
    • Texas
      • Seguin, Texas, United States, 78155
        • Dr. Clark Colville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Invisalign patients from selected pool of investigators

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Teen
< 17 years of age
Device: Invisalign
Adult
17 years of age or older
Device: Invisalign
Adult with Primer Aligners
17 years of age or older This group will get Primer Aligners
Device: Invisalign

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Planned to Final Tooth Position
Time Frame: Through study completion, an average of 2 years
Test vs Historical Control Group
Through study completion, an average of 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment time
Time Frame: Through study completion, an average of 2 years
Length of treatment
Through study completion, an average of 2 years
Subject Quality of Life
Time Frame: Through study completion, an average of 2 years
Assessment of QoL
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Align Technology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSP-300313-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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