Primer Aligner Study

To demonstrate that a primer aligner product can achieve similar results to the currently marketed product.

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. Each aligner is worn for about two weeks, then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Cambridge, England, United Kingdom, CB3 9PA
      • Anglia Orthdontics
    • Chigwell, England, United Kingdom, IG6 2QP
      • Bluebell Dental Practice
    • London, England, United Kingdom, SE13 7FD
      • Dream Smile Dental Clinic
  • Leicestershire
    • Melton Mowbray, Leicestershire, United Kingdom, LE13 0TR
      • High Street Dental Care
  • Northampton
    • Brixworth, Northampton, United Kingdom, NN6 9DS
      • Brixworth Dental Practice
  • Scotland
    • Edinburgh, Scotland, United Kingdom, EH3 5DQ
      • Cherrybank Dental Spa
• United States
  • Arizona
    • Anthem, Arizona, United States, 85086
      • Wood Orthodontics
  • California
    • Napa, California, United States, 94558
      • Cooke Orthodontics
    • Oakland, California, United States, 94612
      • The Orthodontic Center
    • San Francisco, California, United States, 94108
      • Green Dentistry
    • San Jose, California, United States, 95131
      • Align Technology, Inc.
  • Connecticut
    • Bristol, Connecticut, United States, 06010
      • Posner, Henderson & Goslee Dentistry
    • Cheshire, Connecticut, United States, 06410
      • Feldman Orthodontics
  • New York
    • Eastchester, New York, United States, 10709
      • Comizio Orthodontics
    • Little Neck, New York, United States, 11362
      • Magic Touch Orthodontist
    • Mineola, New York, United States, 11501
      • Meadowbrook Dental Care
  • Ohio
    • Mayfield Heights, Ohio, United States, 44124
      • Wenger Orthodontics
  • Virginia
    • Reston, Virginia, United States, 20191
      • Dental One Reston
  • Washington
    • Bothell, Washington, United States, 98012
      • DMG Dental Design

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject must have fully erupted dentition
• Age range ≥18 years old (Adult subject)
• Subjects who are indicated for either: 5, 7, 10, or 12 aligner sets

Exclusion Criteria:

• Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars)
• Subject who has mixed dentition
• Subject with periodontal disease
• Subject with active caries
• Subject with Temporomandibular Joint Disorders symptoms
• Subject has undergone pre-treatment with any orthodontic appliance 3 months prior to the start of treatment
• Subject has undergone any accelerated orthodontic treatment prior to or during treatment as part of this study
• 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?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 7 Aligner Cohort weartime 1; Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.	Device: Invisalign; 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. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
Experimental: 7 Aligner Cohort weartime 2; Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.	Device: Invisalign; 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. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
Experimental: 12 aligner cohort weartime 1; Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.	Device: Invisalign; 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. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
Experimental: 12 aligner cohort weartime 2; Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.	Device: Invisalign; 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. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Treatment Time	Total treatment time was measured in days. The less days a subject was in treatment, the better.	Approximately 1 year
Rate of Refinement	Rate of Refinement was how often subjects in each cohort required additional aligners in (in addition to their originally prescribed aligners) to treat the malocclusion. For example, if a subject was originally prescribed 20 aligners for treatment, but then needed 10 more aligners, the 10 extra aligners would be considered the "refinement." The Rate of Refinement for each cohort was measured as the total number of additional aligners required to complete orthodontic treatment divided by the total number of aligners that were initially prescribed to complete treatment, multiplied by 100. The smaller the rate of refinement (%), the better.	Approximately 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Satisfaction.	(Observational, not used in data analysis). Subjects filled out a Quality of Life Survey with a scale rating of 1 (very difficult) to 5 (very easy) on how easy the product was to use and their orthodontic experience to date. A higher score on the scale meant a better outcome.	Approximately 1 year
Doctor Survey Results.	(Observational, not used in data analysis). Doctors filled out a Doctor Survey with a scale rating of 1 (very difficult) to 5 (very easy) on how easy the product was to use and their satisfaction with the product. A higher score on the scale meant a better outcome.	Approximately 1 year

Collaborators and Investigators

• Sponsor: Align Technology, Inc.
• Investigators: Principal Investigator: Ahmed Moneim, DDS, Los Gatos Dental Center

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: July 23, 2015
• First Submitted That Met QC Criteria: September 14, 2015
• First Posted (Estimate): September 16, 2015

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: CSP-300307-00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes