search
Back to results

Primer Aligner Study

Primary Purpose

Malocclusion

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Invisalign
Sponsored by
Align Technology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Wood Orthodontics
  • Cooke Orthodontics
  • The Orthodontic Center
  • Green Dentistry
  • Align Technology, Inc.
  • Posner, Henderson & Goslee Dentistry
  • Feldman Orthodontics
  • Comizio Orthodontics
  • Magic Touch Orthodontist
  • Meadowbrook Dental Care
  • Wenger Orthodontics
  • Dental One Reston
  • DMG Dental Design
  • Anglia Orthdontics
  • Bluebell Dental Practice
  • Dream Smile Dental Clinic
  • High Street Dental Care
  • Brixworth Dental Practice
  • Cherrybank Dental Spa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

7 Aligner Cohort weartime 1

7 Aligner Cohort weartime 2

12 aligner cohort weartime 1

12 aligner cohort weartime 2

Arm Description

Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.

Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.

Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.

Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.

Outcomes

Primary Outcome Measures

Total Treatment Time
Total treatment time was measured in days. The less days a subject was in treatment, the better.
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.

Secondary Outcome Measures

Full Information

First Posted
July 23, 2015
Last Updated
January 15, 2021
Sponsor
Align Technology, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02550938
Brief Title
Primer Aligner Study
Official Title
Primer Aligner Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Align Technology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
7 Aligner Cohort weartime 1
Arm Type
Experimental
Arm Description
Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
Arm Title
7 Aligner Cohort weartime 2
Arm Type
Experimental
Arm Description
Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Arm Title
12 aligner cohort weartime 1
Arm Type
Experimental
Arm Description
Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
Arm Title
12 aligner cohort weartime 2
Arm Type
Experimental
Arm Description
Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Intervention Type
Device
Intervention Name(s)
Invisalign
Intervention 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 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.
Primary Outcome Measure Information:
Title
Total Treatment Time
Description
Total treatment time was measured in days. The less days a subject was in treatment, the better.
Time Frame
Approximately 1 year
Title
Rate of Refinement
Description
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.
Time Frame
Approximately 1 year
Other Pre-specified Outcome Measures:
Title
Subject Satisfaction.
Description
(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.
Time Frame
Approximately 1 year
Title
Doctor Survey Results.
Description
(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.
Time Frame
Approximately 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Moneim, DDS
Organizational Affiliation
Los Gatos Dental Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wood Orthodontics
City
Anthem
State/Province
Arizona
ZIP/Postal Code
85086
Country
United States
Facility Name
Cooke Orthodontics
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Facility Name
The Orthodontic Center
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Green Dentistry
City
San Francisco
State/Province
California
ZIP/Postal Code
94108
Country
United States
Facility Name
Align Technology, Inc.
City
San Jose
State/Province
California
ZIP/Postal Code
95131
Country
United States
Facility Name
Posner, Henderson & Goslee Dentistry
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Feldman Orthodontics
City
Cheshire
State/Province
Connecticut
ZIP/Postal Code
06410
Country
United States
Facility Name
Comizio Orthodontics
City
Eastchester
State/Province
New York
ZIP/Postal Code
10709
Country
United States
Facility Name
Magic Touch Orthodontist
City
Little Neck
State/Province
New York
ZIP/Postal Code
11362
Country
United States
Facility Name
Meadowbrook Dental Care
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Wenger Orthodontics
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Dental One Reston
City
Reston
State/Province
Virginia
ZIP/Postal Code
20191
Country
United States
Facility Name
DMG Dental Design
City
Bothell
State/Province
Washington
ZIP/Postal Code
98012
Country
United States
Facility Name
Anglia Orthdontics
City
Cambridge
State/Province
England
ZIP/Postal Code
CB3 9PA
Country
United Kingdom
Facility Name
Bluebell Dental Practice
City
Chigwell
State/Province
England
ZIP/Postal Code
IG6 2QP
Country
United Kingdom
Facility Name
Dream Smile Dental Clinic
City
London
State/Province
England
ZIP/Postal Code
SE13 7FD
Country
United Kingdom
Facility Name
High Street Dental Care
City
Melton Mowbray
State/Province
Leicestershire
ZIP/Postal Code
LE13 0TR
Country
United Kingdom
Facility Name
Brixworth Dental Practice
City
Brixworth
State/Province
Northampton
ZIP/Postal Code
NN6 9DS
Country
United Kingdom
Facility Name
Cherrybank Dental Spa
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH3 5DQ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Primer Aligner Study

We'll reach out to this number within 24 hrs