Transparent Braces, A Straighter Smile: It All Computes

Originally Published MDDI June 2002

MEDICAL DESIGN EXCELLENCE AWARDS 2002

Invisalign

Submitted and manufactured by Align Technology Inc. (Santa Clara, CA)

In the past, straightening one's teeth meant wearing metal wires and brackets and rubber bands in one's mouth—an uncomfortable treatment that was obvious to everyone and tended to result in the need to treat cavities once the braces were removed, since teeth couldn't be thoroughly cleaned with the devices in place. Align Technology's Invisalign, a new method for straightening teeth, revolutionizes the business of creating perfect smiles.

"Invisalign is nearly invisible—it's aesthetically unmatched by conventional or even clear ceramic braces," says Amir Abolfathi, vice president of research and development for Align Technology. "The braces, which we call Aligners, are made of a proprietary polyurethane material, which is comfortable to wear; there is no more metal to poke a patient's cheeks. And perhaps most importantly, they're removable so they're much more hygienic. Patients can remove them for normal eating and drinking, or if they're attending an important event. They give patients more flexibility and greater self-confidence."

In addition, gone are the days of returning to an orthodontist or general dental practitioner (GP) every two to three weeks to have braces tightened. With Invisalign, a clinician can dispense three to four sets of Aligners every six to eight weeks, saving both patients and clinicians valuable in-office time. Aligners are worn for two weeks at a time, then the patient moves to the next set. Each set progressively moves the patient's teeth closer to the desired final positions.

Align Technology also has revolutionized the manufacturer-clinician relationship, creating a true collaboration in how devices are developed for each patient. The clinician may submit a prescription to Align Technology on-line and then mail physical data, including the patient's set of impressions, wax bites that show the relationships between the upper and lower teeth, x-rays, and a diagnostic treatment plan.

Virtual-orthodontic technicians at Align Technology then enter that data into a special software program, Treat, to create a three-dimensional digital model of the patient's current teeth position and a treatment plan showing how the teeth will incrementally be moved to the desired positions through a series of Aligner sets. Within 10 days, clinicians may log onto the manufacturer's Web site and use the ClinCheck software to review, and modify if necessary, the plan before manufacturing begins.

"We needed an interface between the customers and the manufacturing folks that would let everyone approach treatment from the same perspective," Abolfathi explains. "Orthodontists and GPs want to see images at every angle before they will accept a treatment plan. A two-dimensional fax or printout screen from the Web wouldn't have been sufficient. With ClinCheck, they basically watch a movie of the treatment plan. They press 'play,' and they see a three-dimensional representation of the patient's teeth in any angle they'd like from the initial stage through the final phase of treatment. Plus, the images are easy for them to manipulate if they'd like to modify the treatment plan."

Certainly the most exciting features about the product are its near invisibility and ability to be removed as needed by the patient, both of which are made possible by the material from which the Aligners are made. Align Technology is currently on its third generation of material for Aligners in its continuing quest to provide a material that is strong enough to move teeth while maintaining enough flexibility to allow for removal, transparency to allow for proper aesthetics, and durability. "We started with a material that was on the market, then we moved to a polycarbonate, and now we're using a proprietary polyurethane," Abolfathi says. "We'll continue to improve the material in future versions."

Align Technology also is conducting a study at the University of Florida to learn by how much the incidence of cavities and calcification is reduced by wearing Invisalign rather than conventional braces. Data should be released next spring. If the product does indeed reduce those numbers, as expected, that will give patients who need to straighten their teeth one more reason to smile.

Copyright ©2002 Medical Device & Diagnostic Industry