Dentists, lawmakers call for more regulation of DIY orthodontics

BOSTON — Anyone who has looked into straightening their teeth can tell you just how expensive the procedures are. That’s why hundreds of thousands of patients have turned to “do-it-yourself” straighteners.

The billion-dollar “direct to consumer" dental industry has online-based companies popping up here in Massachusetts, with SmileDirectClub leading the pack.

Boston 25 Investigates found members of Congress, dozens of attorneys general, and public health boards across the country are asking for more regulations -- as are several patients like Sharon Snowdale of Plymouth.

“Day one, from month one to month three [to] week three, and there was no change," said Snowdale.

The single mom of three tells us she couldn't afford to spend any more money at the orthodontist.

“Being a mom, you put yourself last,” she said. “I put my youngest son and eldest daughter through braces.”

She turned to SmileDirectClub last summer but says no one from the teledentistry company ever looked at her teeth first hand. Still, for about $1,900, SmileDirectClub mailed her the same aligners she could get at the orthodontist. She tells Boston 25 News the thousands of dollars she saved was not worth the pain. She stopped wearing them after three months.

“My back teeth never touched each other, my front teeth were killing me,” she said. “My front teeth always felt like they were going to shatter.”

Snowdale says after a few weeks of back and forth, the company asked her to visit a SmileDirectClub location in Attleboro.

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“I put my retainer back in and I showed them, ‘look it is hanging off my teeth, they don’t fit,’ but the staff just said, ‘Oh your teeth are great, your teeth are wonderful. There’s nothing wrong.’ I haven’t been to an orthodontist,” Snowdale said. “I’m afraid if there’s damage of what there might be.”

About six months later, she agreed to face her fears as we introduced her to the President of Medicaid Orthodontists of Massachusetts Association Dr. Mouhab Rizkallah.

“I see breakage on her teeth and some gum issues that concern me,” Rizkallah said.

The doctor evaluated Snowdale and tells us, she should never have been a candidate for aligners and the best thing she did was to stop wearing them.

Dr. Rizkallah says 100 percent of patients both in his office and doing it from home will develop biting trauma called dental fremitus and if patients don’t see an orthodontist regularly to fix it, there could be permanent damage.

“Overtime, those teeth will break,” Rizkallah said. “The gums will recede, the bone will be lost and the tooth will change colors. It will go dark. This is standard if you don’t fix it.”

We spoke to several patients, orthodontists and dentists who tell us these types of direct to consumer complaints are common.

“We’ve seen people who have had tens of thousands of dollars of dentistry needed as a result of trying to save some money in orthodontics so it is a very high-risk sport,” said Dr. Andrew Chase of Arch Orthodontics. “You could do something you’re not trying to do.”

“We contacted the Board of Registration and Dentistry because we really do believe this is an unregulated practice in dentistry because who is doing the dentistry? Who is the ultimate person in charge of care,” said Dr. Janis Moriarty President of Massachusetts Dental Society.

We also have complaints to the Attorneys General from 36 states, including Massachusetts. There are complaints from both state and national orthodontist associations.

There are even lawsuits and countersuits. Most recently, on Jan. 6, 2020, nine members of the U.S. House of Representatives sent a letter to the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) “to express [their] concern regarding SmileDirect.”

There are also thousands of complaints from patients online. Some complainants say SmileDirectClub hurt their teeth. Others ask the company to follow stricter regulations with a licensed orthodontist taking x-rays and overseeing care.

“A complaint alone doesn’t make it legitimate,” said Rizkallah. “Anybody can complain, but in general, x-rays are not being taken. When patients are not being heard, when you don’t know if the person has an infection, that’s bad. “If I were to do that as a practitioner, I would lose my license and yet somehow this is something they can do not on a one to one scale, they are doing this on a national-like scale. There’s no way to follow the BORID (Board of Registration in Dentistry) regulations without an in-person doctor...however, the enforcement has not caught up with them yet."

For more than a month, we called and emailed SmileDirectClub more than a dozen times trying to get specific answers to our questions. So, we popped into the same location Snowdale visited.

“Sorry, but all the media has to go through the home office,” a manager told us.

Later that day, SmileDirect called us back to schedule a phone call addressing complaints.

“We have been investigated by over 36 states with the prompting of the AAO and not a single dental board has taken any final action against SmileDirectClub, stating that we have engaged in the inappropriate practice of dentistry because we do not,” said SmileDirectClub’s chief legal officer Susan Greenspon Rammelt. She couldn’t answer any questions about fremitus or speak about Snowdale’s specific case.

Smile Direct Club did connect us with their Chief Clinical officer, Dr. Jeffrey Sulitzer, over the phone.

Dr. Sulitzer told us he believes Dr. Rizkallah’s definition and beliefs about fremitus were wrong, in his opinion. When we asked him for specifics, he wouldn’t elaborate further. We tried to connect Dr. Sulitzer and Snowdale on a phone call, but were unsuccessful.

The company did provide a quote from the Executive Director of the American Teledentistry Association Marc Ackerman, DMD, MBA.

“Fremitus is a palpable or visible movement of a tooth when subjected to occlusal forces. In plainer English, it is when you tap the teeth together and hold your finger against a tooth or teeth and feel it vibrate or slightly move. Many would argue that this is physiologic or a normal effect of biting. Many Dentists will argue that if occlusal contacts on the teeth are excessive, then the teeth can have bone loss or periodontal disease etc... Fortunately, there is no evidence to support it.”

—  Executive Director of the American Teledentistry Association Marc Ackerman, DMD, MBA

SmileDirectClub also couldn’t speak about Snowdale’s specific case citing patient privacy laws, but says patients do remote check-ins every 90 days. Dr. Rizkallah asks his patients to come in every 6 weeks.

We asked if the company plans to make any changes with all of the complaints coming its way.

“With today’s technology, you can use photographs and imaging from highly sophisticated cameras to capture many of the same things that you can get in person. This is a company that has enabled more than 750,000 consumers to have access to care with the wild majority of them being satisfied with the results,” Greenspon Rammelt said. “Less than one percent of the consumers who have used our model to get this care have had any sort of clinical concerns.”

Charis Brown, of Atlanta, says she’s one of the satisfied patients.

“My teeth are a little straighter, which is great,” said Brown. “I compared the costs, and I thought, especially since I didn't have a lot of changes that I needed with my teeth, I thought Smile Direct should be fine, because it’s just small changes.”

But as for Snowdale, Dr. Rizkallah says it will take about 12 months of braces for her to finally get the smile she was hoping for.

When he asked her why she was so emotional during her visit, Snowdale said, “Because I always wanted to have straight teeth.”

The dentists and orthodontists we talked to say they don’t necessarily want to shut down companies like Smile Direct, they just want more regulations to ensure patient safety. Otherwise, they say customers may end up spending more than they would’ve initially whether it’s right away or several years down the road.

How one direct-to-consumer company is working to improve oversight Candid, a direct-to-consumer company, says it is working to provide affordable straightening with fewer complaints and to assuage oversight concerns. We sat down with Cathrin Bowtell, chief revenue officer, to discuss.

We also spoke with another Direct to Consumer company: Candid who tells us it’s working to address some of the oversight concerns to provide affordable straightening with fewer complaints.

“One of the big differences about Candid is that we really focus on our approach being the most clinically robust in the industry,” said chief revenue officer Cathrin Bowtell. “That means we never sub out an orthodontist for a dentist. We only work with orthodontists who prescribe and oversee every treatment plan that we offer for our customers.”

Bowtell says Candid started about four years after SmileDirectClub and that helped it sidestep some of the complaints on its competitor.

“Even when we are not in the bulls-eye, we are paying close attention,” Bowtell said about the complaints. “We at Candid are happy that governing bodies and regulators are looking at the space. That is the process working. Anytime there is innovation, particularly in healthcare there should be questions and there should be conversations between innovators and governing bodies. What regulators want and what Candid wants is actually very aligned and that’s why we are optimistic that as we work through this together we will land in a place that works for the business model and for the citizens of Massachusetts. That alignment is making sure people have access to safe affordable healthcare that is expert-driven.”

Bowtell also could not address issues of fremitus, but says Candid is now planning to do more X-rays.

“We are actually including X-rays in every one of our studios,” said Bowtell. “Probably by April every single one of Candid studios will have an X-ray.”

The dentists and orthodontists we talked to say they don’t necessarily want to shut down these companies, they just want more regulations to ensure patient safety. Otherwise, they say customers may end up spending more than they would’ve initially whether it’s right away or several years down the road. They fear because of non-disclosure forms their patients have signed, the problem is actually worse than reported.

“We will give you your money back because it didn’t work. We are sorry but don’t tell anybody,” Dr. Moriarty said of the forms. “So there could be more problems than we know about.”

“For those consumers who don’t abide by the refund policy but are seeking a refund in any event, we do request they sign a general release which has non-disclosure provisions in it. It is good solid business practices to have a nondisclosure in those situations so you were not taken advantage of by other consumers,” Greenspon Rammelt responded. “Anytime you are a disruptor in an entrenched industry, you will find that powerful trade associations will say and do whatever they can to try and sway the marketplace from buying into your model,” The dental industry has opposed Invisalign when they first came out, they opposed fluoride when they first came out, whitening by non-dentist when they first came about, and they certainly oppose dental therapist so this is something that was expected.”

“I empathize and understand that our model is challenging their model and ultimately I want what they want. We all want to be able to give people straighter teeth and more confidence and I’m very comfortable with the way we are approaching that,” said Bowtell.

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