Primer Aligner Study
1 other identifier
interventional
253
2 countries
19
Brief Summary
To demonstrate that a primer aligner product can achieve similar results to the currently marketed product.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2015
Longer than P75 for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 23, 2015
CompletedFirst Posted
Study publicly available on registry
September 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedResults Posted
Study results publicly available
February 3, 2021
CompletedFebruary 3, 2021
January 1, 2021
5.3 years
July 23, 2015
November 17, 2020
January 15, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Subject Satisfaction.
Approximately 1 year
Doctor Survey Results.
Approximately 1 year
Study Arms (4)
7 Aligner Cohort weartime 1
EXPERIMENTALSeven Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
7 Aligner Cohort weartime 2
EXPERIMENTALSeven Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
12 aligner cohort weartime 1
EXPERIMENTALTwelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention.
12 aligner cohort weartime 2
EXPERIMENTALTwelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Wood Orthodontics
Anthem, Arizona, 85086, United States
Cooke Orthodontics
Napa, California, 94558, United States
The Orthodontic Center
Oakland, California, 94612, United States
Green Dentistry
San Francisco, California, 94108, United States
Align Technology, Inc.
San Jose, California, 95131, United States
Posner, Henderson & Goslee Dentistry
Bristol, Connecticut, 06010, United States
Feldman Orthodontics
Cheshire, Connecticut, 06410, United States
Comizio Orthodontics
Eastchester, New York, 10709, United States
Magic Touch Orthodontist
Little Neck, New York, 11362, United States
Meadowbrook Dental Care
Mineola, New York, 11501, United States
Wenger Orthodontics
Mayfield Heights, Ohio, 44124, United States
Dental One Reston
Reston, Virginia, 20191, United States
DMG Dental Design
Bothell, Washington, 98012, United States
Anglia Orthdontics
Cambridge, England, CB3 9PA, United Kingdom
Bluebell Dental Practice
Chigwell, England, IG6 2QP, United Kingdom
Dream Smile Dental Clinic
London, England, SE13 7FD, United Kingdom
High Street Dental Care
Melton Mowbray, Leicestershire, LE13 0TR, United Kingdom
Brixworth Dental Practice
Brixworth, Northampton, NN6 9DS, United Kingdom
Cherrybank Dental Spa
Edinburgh, Scotland, EH3 5DQ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Allison Mossing, Sr. Clinical Research Associate
- Organization
- Align Technology, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Moneim, DDS
Los Gatos Dental Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2015
First Posted
September 16, 2015
Study Start
May 1, 2015
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
February 3, 2021
Results First Posted
February 3, 2021
Record last verified: 2021-01