One Week Aligner Evaluation

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

Study Overview

• Status: Completed
• Conditions: Malocclusion
• Intervention / Treatment: Device: Invisalign

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: Observational
• Enrollment (Actual): 287

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Planned to Final Tooth Position	Test vs Historical Control Group	Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment time	Length of treatment	Through study completion, an average of 2 years
Subject Quality of Life	Assessment of QoL	Through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Align Technology, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: CSP-300313-00