About Invisalign and Align Technology, Inc

Smile Makeover Bartlesville OKAlign Technology, Inc., headquartered in Santa Clara, California, was founded in March 1997 to develop a next-generation, aesthetic orthodontic product.

Invisalign, Align's core product, combines proven orthodontic science with 3-D computer graphics and mass customization technology. Invisalign has two primary components: ClinCheck and Aligners. ClinCheck is the Internet-based application that allows orthodontists to simulate treatment in 3-D by modeling stages of tooth movement. Aligners are thin, nearly invisible, removable dental appliances that correspond to each stage of the ClinCheck simulation and are used to straighten teeth. Because it does not rely on metal or ceramic brackets and wires, Invisalign offers doctors and patients an aesthetic and comfortable alternative to traditional braces.

To date, Align has received two industry awards for its design and production of Invisalign - the 2002 Medical Design Excellence Award and the 2001 Stereolithography Excellence Award. The technology behind Invisalign is cutting-edge, but the idea of using a series of appliances to move teeth is not new to orthodontics. In 1945, Dr. Kesling first described the concept of moving teeth using a series of planned, individual stages. He realized that the lab requirements would be significant, and could not envision a practical way to make the idea a reality. Kesling did have the foresight to state that technology would one day be available to make such treatment possible.

Today, Align is one of the largest manufacturers of mass customized products in the world. More than 100,000 patients have entered treatment with Invisalign, and more than five million unique Aligners have been produced.

Clinical Studies

Align Technology conducted a number of private and university-based clinical studies across the U.S. prior to commercially releasing Invisalign. Align has launched new clinical studies to expand applicability and determine specific Aligner properties. As a result of these clinical studies, the range of applicability demonstrated by Invisalign has expanded significantly. A sample of on-going studies is listed below. (last updated 09/17/03)

University Based Studies

University of the Pacific School of Dentistry - Align is working with the University of Pacific to study a range of mild to severe malocclusions including bicuspid extractions, anterior open bites, and severe rotations. As a result, one article has already been published in the December 2001 issue of Seminars in Orthodontics titled, Three-dimensional diagnosis and orthodontic treatment of complex malocclusions with the Invisalign appliance.

University of Washington - Align is working with the University of Washington to conduct a randomized clinical trial to study the effectiveness of different materials and different treatment times for Invisalign. An abstract on the frequency of activation and stiffness of Invisalign Appliances was presented at the 2003 AADR/IADR meeting.

University of Florida - Align is working with the University of Florida to conduct a randomized clinical trial to study various attachment designs for extrusion, rotation, and intrusion of teeth to be used with the Invisalign appliance. A secondary goal of the study is to obtain descriptive data regarding the incidence of side-effects such as caries incidence, gingival inflammation, root resorption, and temporomandibular joint changes, associated with wearing ALIGN appliances. An abstract on the effect of Invisalign Aligners on periodontal tissues was presented at the 2003 AADR/IADR meeting.

University of Ferrara, Italy - Align is conducting a randomized clinical trial with the University of Ferrara to study the effectiveness of using an aligner material, Exceed 40 (EX40) in the Invisalign treatment process and its prevalence on case refinements and mid-course corrections. Descriptive data related to potential risk factors associated with wearing Ex40 on oral hygiene, tooth sensitivity, root resorption, and temporamandibular joint discomfort will be examined.

Tel Aviv University - Align is conducting a clinical trial at Tel Aviv University to measure strain changes over time in Aligners as they are worn and determine the forces produced by these strains, and then correlate the strains and forces with the movements and speeds programmed into the appliance.

Private Practice Studies

Bicuspid Extraction Combination Study - Align is working with an Orthodontist to conduct a randomized clinical trial to evaluate the outcome of treating bicuspid extraction cases using Invisalign in combination with braces.

Adolescent Study - Align is working with a number of doctors to conduct a randomized clinical trial to evaluate the outcome of treating Class I crowding and spacing malocclusions in adolescent patients, aged 12-18, using Invisalign.

Case Refinement Study - Align is working with a couple of orthodontists to evaluate the use of a thicker material at the end of treatment and the use of automated overcorrection to reduce case refinement. A secondary goal of this study is to obtain data regarding the types of tooth positions that require overcorrection and the amount of overcorrection required to achieve the results shown at the final stage on Clincheck.

Virtual vs. Actual Treatment Study - Align is conducting a preliminary case study with an orthodontist on the comparison of Invisalign's virtual treatment to that of actual treatment results at every Aligner stage. The goals will be to measure teeth location differences between the virtual and real representations and analyze tooth dynamics throughout the treatment.

New Attachment Study - Align is working with a number of doctors to conduct a clinical trial to evaluate a new attachment concept and design for extrusions of incisors, canines, and premolars, and rotations of canines and premolars.

The Invisalign System: Case Report of a Patient With Deep Bite, Upper Incisor Flaring, and Severe Curve of Spee
By Dr. Ross J. Miller and Dr. Mitra Derakhshan
Seminars in Orthodontics, March 2002

This article is a case presentation for a 46-year-old man with the chief complaint of upper spacing. The treatment objectives were to close all upper spaces and reduce the overjet by retroclining and retracting upper incisors. Intruding lower incisors would level the curve of Spee and thus decrease overbite. Lower crowding was to be resolved by proclination and interproximal reduction, if needed. The buccal occlusion and Class I were to be maintained. This article addresses the treatment progress and results. Facial and intraoral photographs, as well as radiographs are included in this eight-page article.

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Dr Ron Hart DDS - Providing services in cosmetic dentistry and invisalign to the areas of Independence and Coffeyville, Kansas (KS), Tulsa and Bartlesville, Oklahoma (OK).

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