Class II Correction Study Using the Invisalign System

Align Technology

Status

Completed

Conditions

Malocclusion

Treatments

Device: Invisalign System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02376829

MRF-002

Details and patient eligibility

About

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

Full 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.

Enrollment

164 patients

Sex

All

Ages

11 to 19 years old

Volunteers

Accepts Healthy Volunteers

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