Class II Correction Study Using the Invisalign System

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.

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