Class II Correction Study Using the Invisalign System
Completed · Not applicable
Conditions studied: Malocclusion
In brief
To demonstrate that growing teenagers which present up to full cusp Class II malocclusions can be treated using the Invisalign System.
Key facts
- Study ID
- NCT02376829
- Run by
- Align Technology, Inc.
- People needed
- 164
- Starts
- 2015-03-01
- Expected to finish
- 2021-11-23
- Last updated by the study team
- 2023-05-06
Who can join
Age: 11 and older, up to 19. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Dr. Gary Brigham — Scottsdale, Arizona, United States
- Dr. Donna Galante — Rocklin, California, United States
- Dr. Mark Holt — Roseville, California, United States
- Dr. Ray Kubisch and Dr. Drew Ferris — Santa Barbara, California, United States
- Dr. Sandra Selnick — Ellicott City, Maryland, United States
- Dr. Regina Blevins — Inver Grove Heights, Minnesota, United States
- Dr. William Kottemann — Maple Grove, Minnesota, United States
- Dr. Barry Glaser — Cortlandt Manor, New York, United States
- Dr. Sam Daher — Vancouver, British Columbia, Canada
- Dr. Sandra Tai — Vancouver, British Columbia, Canada
Full record on ClinicalTrials.gov
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