CHICAGO, U.S.: There has been an influx of do-it-yourself dentistry products onto the market, and dentists and dental organizations around the world have had some concerns about the possibility that patients might be putting themselves in danger. Recently, the American Dental Association (ADA) sent a letter to the Federal Trade Commission’s Bureau of Consumer Protection regarding aspects of SmileDirectClub’s marketing and direct-to-consumer sales of plastic tooth aligners. According to the ADA, this action was taken out of concern for consumers.
“Moving teeth without knowing all aspects of a patient’s oral condition has the potential to cause the patient harm,” said ADA President Dr. Jeffrey M. Cole. “Orthodontic treatment, if not done correctly, could lead to potential bone loss, lost teeth, receding gums, bite problems, jaw pain, and other issues.”
According to the ADA, its biggest concern is the need for patients to self-report their dental condition, in that this does not meet the standard level of care and that it cannot be expected that laypersons would be familiar with specialized technical or medical vocabularies. “The ADA considers it our duty on behalf of the public to make the relevant regulatory agencies aware of what is going on so they can consider whatever actions they deem appropriate,” Cole noted.
More than two months prior to this recent letter, the ADA filed a citizen petition with the U.S. Food and Drug Administration (FDA). In that petition, it stated that SmileDirectClub is placing the public at risk by knowingly evading the FDA’s “by prescription only” restriction on tooth aligning materials.
In a statement to Dental Tribune International regarding the complaint against SmileDirectClub, the company said: “SmileDirectClub’s affiliated network of 250+ dentists and orthodontists are equally concerned about oral health, whether they see their patients in a traditional office setting or provide remote clear aligner therapy through modern innovations in technology, inclusive of our web-based teledentistry platform.”
SmileDirectClub also noted that 95% of its affiliated dentists and orthodontists treat patients in a brick-and-mortar office and that all of them have had at least four years of clear aligner therapy experience in a traditional setting. The company added: “This growing network of dentists and orthodontists believe in our mission to democratize access to safe and affordable clear aligner therapy and have helped more than 650,000 people achieve a straighter smile.”
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