Primer Aligner Study

Align Technology, Inc.253 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

253

Conditions

Malocclusion

Interventions

InvisalignDEVICE

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

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (19)

Wood Orthodontics

Anthem, Arizona, United States

Cooke Orthodontics

Napa, California, United States

Outcomes

Primary Outcomes

Total Treatment Time

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

Time frame: 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.

Time frame: Approximately 1 year

Data from ClinicalTrials.gov

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