Primer Aligner Study
NCT02550938 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 253
Last updated 2021-02-03
Summary
To demonstrate that a primer aligner product can achieve similar results to the currently marketed product.
Conditions
- Malocclusion
Interventions
- DEVICE
-
Invisalign
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 a defined period of time , 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.
Sponsors & Collaborators
-
Align Technology, Inc.
lead INDUSTRY
Principal Investigators
-
Ahmed Moneim, DDS · Los Gatos Dental Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2020-09-30
- Completion
- 2020-09-30
- FDA Device
- Yes
Countries
- United States
- United Kingdom
Study Locations
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