Class II Correction Study Using the Invisalign System

Study Overview
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Brief Summary
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To demonstrate that growing teenagers which present up to full cusp Class II malocclusions can be treated using the Invisalign System.

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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Class II Correction Study Using the Invisalign System

Conditions
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Malocclusion

Intervention / Treatment
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* Device: Invisalign System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have fully erupted dentition excluding 2nd and 3rd molars Age range 11-19 years old Subject that requires bilateral Class II correction and must require at least 3mm of correction as measured by first molar relationship Exclusion Criteria: Subject who has unerupted, erupting, partially erupted dentition (except for 2nd and 3rd molars) Subject who has spaces between adjacent teeth larger than 3mm Subject with active caries Subject with periodontal disease Subject does not have at least 1st molar fully captured in PVS (polyvinyl siloxane material ) impression or intraoral scan. Subject with TMD (Temporomandibular joint dysfunction) symptoms Subject has undergone pre-treatment with any orthodontic appliance (any previous treatment prior to study) Subject has known allergy to latex and plastic Subjects who are pregnant or will become pregnant during treatment

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 19 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Invisalign System<br>Class II correction of malocclusions | Device: Invisalign System<br>* The Invisalign® System is indicated for the alignment of teeth during orthodontic treatment of malocclusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Tooth Movement at the End of Class II Correction. | The primary objective will be met through demonstrating that the velocity of Invisalign with MRF overjet correction is non-inferior to the published rates of Dynamax (0.42mm/month). | End of Class II Correction up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Treatment Time | This is the total treatment length of time that subjects took (in days) to complete Invisalign system treatment | End of Treatment approximately 2 years | 
| Patient Quality of Life Questionnaire Throughout Treatment | As part of the secondary objective, subject perception was assessed through analysis of case report forms. Case report form analysis of the Quality of Life forms was conducted from the subjects in both the Clinical Study and Continued Access Clinical Study. Subjects were asked to rate their orthodontic experience throughout the course of the study, with options 1(very difficult), 2 (difficult), 3 (average), 4 (easy), and 5 (very easy) as the ratings. | End of Treatment approximately 2 years | 
| Doctor Survey for Satisfaction With Treatment Outcomes | Doctors filled out a Doctor Survey with a scale rating of 1 (very difficult) to 5 (very easy) on how easy the product was to use and their satisfaction with the product. A higher score on the scale meant a better satisfaction experience . | End of Treatment approximately 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthodontic, Orthodontic Treatment, Clear Aligners, Malocclusion