Primer Aligner Study

Not Applicable

Completed

• Conditions: Malocclusion

• 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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-16
• Primary Completion: 2020-09
• Study Completion: 2020-09
• Results First Submitted: 2020-11-17
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-15
• Last Update Submitted: 2021-01-15
• Results First Posted: 2021-02-03
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
Total Treatment Time	Approximately 1 year	Total treatment time was measured in days. The less days a subject was in treatment, the better.

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

Align Technology, Inc.; 🇺🇸 San Jose, California, United States

Posner, Henderson & Goslee Dentistry; 🇺🇸 Bristol, Connecticut, United States

Feldman Orthodontics; 🇺🇸 Cheshire, Connecticut, United States

Comizio Orthodontics; 🇺🇸 Eastchester, New York, United States

Magic Touch Orthodontist; 🇺🇸 Little Neck, New York, United States

Meadowbrook Dental Care; 🇺🇸 Mineola, New York, United States

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