Class II Correction Study Using the Invisalign System

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2021-11-23

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.

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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.

Conditions

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Malocclusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The Invisalign System

Class II correction of malocclusions

Group Type EXPERIMENTAL

Invisalign System

Intervention Type DEVICE

The Invisalign® System is indicated for the alignment of teeth during orthodontic treatment of malocclusion

Interventions

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Invisalign System

The Invisalign® System is indicated for the alignment of teeth during orthodontic treatment of malocclusion

Intervention Type DEVICE

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

Minimum Eligible Age

11 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes