Primer Aligner Study

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

Detailed Description
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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.

Official Title
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Primer Aligner Study

Conditions
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Malocclusion

Intervention / Treatment
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* Device: Invisalign


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 7 Aligner Cohort weartime 1<br>Seven Aligner cohort will change aligners at a designated interval Invisalign is the intervention. | Device: Invisalign<br>* 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.<br>|
| Experimental: 7 Aligner Cohort weartime 2<br>Seven Aligner cohort will change aligners at a modified interval Invisalign is the intervention. | Device: Invisalign<br>* 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.<br>|
| Experimental: 12 aligner cohort weartime 1<br>Twelve Aligner cohort will change aligners at a designated interval Invisalign is the intervention. | Device: Invisalign<br>* 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.<br>|
| Experimental: 12 aligner cohort weartime 2<br>Twelve Aligner cohort will change aligners at a modified interval Invisalign is the intervention. | Device: Invisalign<br>* 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.<br>|

What is the study measuring?
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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 |