Clinical trial NCT02376829: Class II Correction Study Using the Invisalign System
Official title: Class II Correction Study Using the Invisalign System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Keywords: Orthodontic
Orthodontic Treatment
Clear Aligners
Malocclusion
Lead sponsor: Align Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-03
Enrollment: 164
Sex: ALL
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Tooth Movement at the End of Class II Correction.
timeFrame: End of Class II Correction up to 18 months
Secondary outcomes:
measure: Length of Treatment Time
timeFrame: End of Treatment approximately 2 years
measure: Patient Quality of Life Questionnaire Throughout Treatment
timeFrame: End of Treatment approximately 2 years
measure: Doctor Survey for Satisfaction With Treatment Outcomes
timeFrame: End of Treatment approximately 2 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Dr. Gary Brigham
state: Arizona
city: Rocklin
country: United States
facility: Dr. Donna Galante
state: California
city: Roseville
country: United States
facility: Dr. Mark Holt
state: California
city: Santa Barbara
country: United States
facility: Dr. Ray Kubisch and Dr. Drew Ferris
state: California
city: Ellicott City
country: United States
facility: Dr. Sandra Selnick
state: Maryland
city: Inver Grove Heights
country: United States
facility: Dr. Regina Blevins
state: Minnesota
city: Maple Grove
country: United States
facility: Dr. William Kottemann
state: Minnesota
city: Cortlandt Manor
country: United States
facility: Dr. Barry Glaser
state: New York
city: Vancouver
country: Canada
facility: Dr. Sam Daher
state: British Columbia
city: Vancouver
country: Canada
facility: Dr. Sandra Tai
state: British Columbia
Study officials:
affiliation: Align Technology, Inc.
name: Sherri Wilson-Lopes
role: STUDY_DIRECTOR
References: