Primer Aligner Study
- Conditions
- Malocclusion
- Interventions
- Device: Invisalign
- Registration Number
- NCT02550938
- Lead Sponsor
- Align Technology, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 253
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 7 Aligner Cohort weartime 2 Invisalign Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention. 7 Aligner Cohort weartime 1 Invisalign Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention. 12 aligner cohort weartime 1 Invisalign Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention. 12 aligner cohort weartime 2 Invisalign Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention.
- Primary Outcome Measures
Name Time Method Total Treatment Time Approximately 1 year Total treatment time was measured in days. The less days a subject was in treatment, the better.
Rate of Refinement Approximately 1 year 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
Name Time Method
Trial Locations
- Locations (19)
Wood Orthodontics
🇺🇸Anthem, Arizona, United States
Cooke Orthodontics
🇺🇸Napa, California, United States
The Orthodontic Center
🇺🇸Oakland, California, United States
Green Dentistry
🇺🇸San Francisco, California, United States
Magic Touch Orthodontist
🇺🇸Little Neck, New York, United States
Feldman Orthodontics
🇺🇸Cheshire, Connecticut, United States
Comizio Orthodontics
🇺🇸Eastchester, New York, United States
Meadowbrook Dental Care
🇺🇸Mineola, New York, United States
Wenger Orthodontics
🇺🇸Mayfield Heights, Ohio, United States
DMG Dental Design
🇺🇸Bothell, Washington, United States
Dental One Reston
🇺🇸Reston, Virginia, United States
High Street Dental Care
🇬🇧Melton Mowbray, Leicestershire, United Kingdom
Cherrybank Dental Spa
🇬🇧Edinburgh, Scotland, United Kingdom
Brixworth Dental Practice
🇬🇧Brixworth, Northampton, United Kingdom
Posner, Henderson & Goslee Dentistry
🇺🇸Bristol, Connecticut, United States
Bluebell Dental Practice
🇬🇧Chigwell, England, United Kingdom
Dream Smile Dental Clinic
🇬🇧London, England, United Kingdom
Anglia Orthdontics
🇬🇧Cambridge, England, United Kingdom
Align Technology, Inc.
🇺🇸San Jose, California, United States