Dangers of Home Evaluation for Clear Aligners

Categories: Blog

Invisalign Clear AlignersA major row has erupted over a mail order orthodontics business model that takes dentists out of the equation in providing clear aligners.

The process involves the customer making a bite cast at home. The impression is then reviewed online by a dentist and a series of aligners delivered by mail at a fraction of the cost of conventional orthodontic treatment.

Critics say orthodontics is an art and science that requires expert assessment by an orthodontist in person, and that with mail order aligners, there’s no clinical examination or direct contact by an orthodontist.

Providers of direct-to-consumer aligners say orthodontist are misleading the public to keep the cost of orthodontic treatment artificially high, and court battles are looming over allegations of libel.

Direct Supervision Needed, say Dentists

The American Association of Orthodontists (AAO) says people considering getting clear aligners – or conventional braces – should only seek treatment under the direct supervision of an orthodontist.

The organization warns that “do-it-yourself” orthodontic treatment can result in lasting damage, and it says orthodontic treatment is a medical service, not a device or product. The AAO has lodged complaints in multiple states against one mail order orthodontic company, alleging the business is creating medical risks by bypassing the orthodontic office.

It has warned of what it describes as the increased likelihood of harm with mail order aligners, in the absence of an initial examination and ongoing supervision by an orthodontist. The AAO said almost 13 percent of its members were treating patients who had tried “do-it-yourself” teeth straightening and added that some of these attempts had caused irreparable damage.

The country’s biggest dental organization, the American Dental Association (ADA), has issued a formal resolution against “do-it-yourself” orthodontics, warning of the “potential harm” to patients.

The policy statement says orthodontists should be in charge of the diagnosis and treatment of patients to ensure safe delivery of appropriate care.

How the SmileDirectClub System Works

A leading player in the direct-to-consumer orthodontics business is Nashville-based SmileDirectClub (formerly SmileCareClub).

This is how its system works:

  1. You complete a questionnaire about your gums and teeth and upload photos.
  2. You receive an at-home kit to take an impression of your mouth or get a 3D scan in a SmileShop.
  3. A state-licensed orthodontist or dentist prescribes your treatment plan unless your case is complex, in which case SmileDirectClub says it refers patients for in-office care.
  4. You start to receive a set of aligners each month over about five months.
  5. At the end of the treatment, you get a retainer to help keep your teeth straight.

SmileDirectClub says its opponents represent a well-funded public relations and lobbying campaign trying to protect their traditional business model by shutting down a rival, and the company is taking legal action to silence orthodontists and other dentists from making what it calls disparaging and false comments about them.

The company disputes that its aligners are “do-it-yourself” braces and says patients are guided through the entire process.

Dentists Stick to Their Guns

In October 2017 lawyers for SmileDirectClub filed suit against Michigan Dental Association (MDA) in the U.S. District Court, alleging trade libel. MDA denies the allegation and says that if necessary it will defend itself vigorously in court.

Meanwhile, other dentists and orthodontists maintain they’re simply airing their professional opinion. The American Dental Association says supervision by a licensed orthodontist is necessary for all stages of orthodontic treatment.

Dr. Craig Ratner, chair of the ADA Council on Dental Practice, said it was necessary to educate patients about potential pitfalls of self-managed orthodontic treatment and explain the importance of dental professionals being in charge of diagnosing and treating patients.

The Food and Drug Administration (FDA) regards aligners as prescription appliances but does not regulate the practice of orthodontics or dentistry, which is governed by states and their dental boards.

SmileDirectClub and Align Technology

Align Technology, the U.S.-based global medical appliance company that makes Invisalign clear aligners, bought nearly one-fifth of SmileDirectClub in 2016 for $46.7 million and now manufactures non-Invisalign aligners for SmileDirectClub’s at-home program.

The relationship between the two companies was discussed on the DentistryIQ platform for dental professionals in November 2017 by Chris Salierno, Doctor of Dental Surgery and chief editor of Dental Economics Magazine.

Salierno praised Align Technology for its efforts in creating a responsible, successful direct-to-consumer marketing drive that has boosted demand for orthodontic services but described the connection with SmileDirectClub as “clouding an otherwise sunny picture”.

He said Align Technology should be careful about how SmileDirectClub engaged with the dental community, adding that dental technology companies, dentists, orthodontists should strive to work together in a mutually beneficial relationship.

“Risk of Permanent Damage”

Writing for HuffPost (formerly The Huffington Post) in 2015, author and orthodontist Richard Schechtman said mail-order orthodontics could not address important issues such as bite function problems or the health of the gums and jaw joints.

He said bypassing the orthodontist resulted in the patient coming to conclusions based on what they perceived as important, not was medically appropriate. Only a certified orthodontist had the skills to decide what was best for a patient, he said.

Schechtman added that “do-it-yourself” orthodontic treatment posed a risk of permanent damage to teeth, including bone loss and root shortening.

Benefits of In-Office Treatment by an Expert

One problem with direct-to-consumer orthodontics is that you might not know whether you’re dealing with an orthodontist or a general dentist.

An orthodontist undergoes two or more years of further training after dental school, giving them greater expertise in fixing crooked teeth and misaligned jaws. Invisalign was designed specifically for treatment by orthodontists but general dentists successfully sued for the right to use the system.

Another issue is that clear aligners aren’t suitable for all orthodontic issues, and a specialist orthodontic practice can offer alternatives such as ceramic or metal braces.

Many well-trained general dentists can treat simple orthodontic cases but there are multiple advantages of finding a certified orthodontist, who will provide expert in-practice treatment and aftercare, and advise you on oral hygiene at home to ensure your teeth remain straight and healthy.