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Someone close to the AAO Council on Governmental Affairs told me an alarming statistic at the meeting in Chicago this weekend. This person said half of all AAO member orthodontists have now seen a patient in private practice where direct-to-consumer (D2C) aligners caused adverse effects (traumatic occlusion, gingival recession, jaw joint pain, etc.) At first glance, had I taken this doctor's claim at face value, I could only logically conclude direct-to-consumer aligners are harming the public. Instead, I zoomed out and quickly ran the math in my mind.

Smile Direct Club, the largest D2C company, has treated more than 1.8 million patients (source: Investor relations, SDC). The American Association of Orthodontists represents 19,000 orthodontist members throughout the United States, Canada and abroad (source: website). If half of all orthodontist members have seen a patient who has been "harmed" by D2C aligners (and even if all of those patients came from SDC, the company specifically mentioned to me and named in the keynote of the annual meeting this year), this represents 9,500 patients out of 1.8 million, or one half of one percent. Said another way, Smile Direct Club is 99.5% effective.

What would happen if we sent all of the before and after patient data to Smile Direct Club from the 19,000 members of the AAO? Would we demonstrate 99.5% efficacy? How often do our appliances, treatment plans and biomechanics cause decalcification, root resorption, jaw joint pain and gingival recession? The average orthodontist treats somewhere in the range of 360 new patients per year. Over a 30-year career, he or she will treat 10,800 patients. Assuming a 99.5% efficacy rate, this orthodontist will retreat no more than 57 patients. Would Smile Direct Club or an independent panel of dentists, prosthodontists and periodontists find no more than 57 retreats or unhappy patients out of 10,800 orthodontic patients treated in-office?

I don't know about you, but I don't make a sloshing sound when I walk.

— Dustin S. Burleson, DDS, MBA

In my practices, we issued refunds to patients who were not completely satisfied with their results or our service, no questions asked. We issued these refunds at a rate of 30-40 per year, not 57 in a career. Granted, we advertised and marketed our practices aggressively, so we started hundreds of cases per month. But the point remains. I was very happy with a 98% satisfaction rating from our patients. I would have traded my bronze baby booties for 99.5%.

How we see anything starts with how we see ourselves.

Are direct-to-consumer aligners causing harm to patients? It's hard to argue with patients who claim this is true. We need to listen to these patients and try to assess what happened, how it could be prevented in the future and what we can do, if anything, to help them move forward with dignity and in comfort. We shouldn't be holding them up as the poster children for our own agenda as orthodontists. When we see ourselves as the experts, the trusted authority in a space, it's easy to become blinded to the possibility that our way of doing things could be improved or even thrown out with the bath water completely.

What is the best path forward for teledentistry and direct-to-consumer aligners? If you've been paying attention to me for any period of time and/or you have even the most basic understanding of free markets, absent regulatory intervention or legislation that prevents these forces from playing out as they always do, products and services move from high cost and low access to decreased cost and increased access. As small business owners and healthcare providers, we must reconcile the decentralization of healthcare, democratization of services, price transparency and data sharing with our own sunk costs, egos and the status quo. Stand in the way of these free market forces too long and you'll be squashed, irrelevant or both.

Video clip from a seminar training session with Dustin Burleson, DDS, MBA explaining the shift towards lower prices and increased access to care for orthodontic patients.

I'm not saying Smile Direct Club should face no scrutiny. Accountability is important and I would no sooner suggest Smile Direct Club is a perfect company than I would repeatedly slam my foot in a car door. They have some advertising and quality assurance obstacles which need to be overcome, and as a shareholder, I'm rooting for them. The point is that we should all face the same scrutiny. Orthodontists, D2C aligner companies, general and pediatric dentists should all adhere to clinical and customer service standards and measure our results with transparency and a sense of service, not competition.

SDC followed a tried-and-true playbook to disrupt sleepy incumbents which required large piles of cash to be burned, only to discover their highest margin and dry ground in partnership with general dental offices, where patients can receive an in-person dental exam and digital scan. They are a smart group of passionate people trying to work in conjunction with free market forces and help more patients receive treatment, so it's very hard for me to stand by and cheer, like thousands of my orthodontic colleagues did in Chicago this weekend when our executive director announced the US Attorney General is suing Smile Direct Club.

At the end of the day, we all want to help patients. If a large company points out that only a small minority of the public is being served by the existing market solution and they try to increase access to care by disrupting the incumbents, then we should all ask what we can learn about ourselves, our patients and the future of healthcare, not stand in the way, insisting we continue to do things the way they've always been done.

Let's dig into our own data and be brutally honest. As a group, we're lobbying state legislators to draft and pass laws which require an in-person dental exam prior to orthodontic treatment. Some states want a doctor to be present for intraoral scanning. At the same time, I can't even begin to count how many orthodontic consultants are teaching doctors and treatment coordinators to do "doctor less" exams via teledentistry to boost capacity. As an aside, please stop calling them "doctor less" exams. This is confusing and misleading. Call them what they are: a teledentistry consultation, teledentistry visit, "e-consult" or "e-visit." The doctor is still a critical component to the exam. I digress.

Are direct-to-consumer aligners dangerous to patients? Maybe they are. Maybe they aren't. The statistic quoted to me about half of all orthodontists seeing a case where there has been patient harm came from a biased group of association members, to which I belong. Can we all admit most orthodontists have skin in the game to see direct-to-consumer aligners go away? What is our response to the orthodontists and dentists who do provide telehealth services through these companies? Are they all evil and we are all good? Do they harm patients while we walk on water?

What would it look like if we engaged in a serious debate so that all stakeholders thrive?

Why not ask an independent panel of orthodontists, dentists, prosthodontists, periodontists and patients what they think are the defining criteria of a good orthodontic outcome. Make an objective list and pile in the data. Label the data from initial and finished orthodontic records and feed those data into a neural network. What predictive factors might help us direct specific patients to customized treatment plans? How can we use the data, see the results and get serious about whether or not many patients could benefit from remote-monitored care while others will not. I'm confident both sides of the debate would learn something, if we're open to being brutally honest and disinterested in the outcome (i.e., more interested in helping our patients and truly serving our communities than we are interested in being right).

What about the patient? Isn't that why we went to school as orthodontists or invested billions of dollars as a D2C corporation? To help people? Could we agree to hire a third-party data analytics firm like Qualtrics to ask patients from both groups (in-office and direct-to-consumer) about their preferences, objectives, fears, frustrations, experience and outcomes. Why not take the clearest and broadest perspective, based on the data, by zooming out? Think of the progress we could make.

Bottom line: It's one thing to say, "We should all sit down and find a way to help more patients achieve the care they deserve." It's something else entirely to make it sound like a dental product is causing harm, when in fact, based on the very simple and generalized math above, it clearly is not.

Show me any medical, dental or consumer product with a 99.5% efficacy and satisfaction rate, and I'll show you a winner. We might not want to admit it due to things like sunk cost, ego and status quo, but sooner or later we're going to have to learn how to zoom out, see the big picture and compromise so that everyone can thrive, not just the orthodontist and his or her bank account, ego or resistance to change.

— Dustin S. Burleson, DDS, MBA

Disclaimers: I'm not an attorney. I'm an orthodontist, member of the AAO, board certified by the American Board of Orthodontics, teach and provide patient care at a children's hospital one day a month and I'm an adjunct assistant professor at a dental school where I instruct orthodontics to the residents in the advanced education program a few half days a month. I grew a large group practice before successfully exiting private practice via private equity in December 2021. I write, speak and teach member doctors at Burleson Seminars and I'm a venture partner in a VC firm. I do own stock in Smile Direct Club along with sizable positions in Align Technology and other key players in the dental industry. None of this should be misconstrued as financial or legal advice. My writing is meant to supplement your common sense, not substitute for it. Years ago, when Smile Direct Club was called Smile Care Club, I was an Endorsed Local Provider (ELP) for a year or two, so that I could learn about the process, the company and help write and teach, fulfilling our vision at Burleson Seminars to advance the profession and serve our community. I share all of this because healthcare providers and investors have biases. We all have biases. Associations have biases and we should all be clear about them if our true aim is to serve the public and advance the profession through clinical excellence. If you have questions or special requests about my writing, teaching or views, please reach out to me directly via the contact form on my website. I'm happy to engage in thoughtful debate and discussion so that all stakeholders in orthodontics and dentistry thrive.

4 Responses to “ Direct to Consumer Aligners and Patient Harm ”

  1. Tushar says:

    Great article Dustin. Totally agree with your points and most docs would agree behind closed doors. Kudos to you for having the guts to publicly make the statement. 🙂

    • Burleson Seminars says:

      Thanks, Tushar. I appreciate your comments and kind words. Cheering you on! – Dustin

  2. Michael McCarthy says:

    Dustin, as always I enjoy your articles and your thoughts. In this case, I cannot agree with the conclusions that you are making based upon the comments of one person even if that person is someone close to the AAO Council on Government Affairs. I think your premise is incorrect. I do not think you can make the very large step that there is a 99.5 efficacy and satisfaction rate for D2C aligners based upon a comment especially when the comment was that half of all AAO member orthodontists in private practice have seen a patient with adverse results from D2C aligners. I would bet this comment is a generalized statement and not based upon any study of D2C aligners. You cannot make the leap that if 4750 orthodontists have seen a patient with adverse effects from D2C aligners that the remaining 1,795,250 were satisfied with their treatment and achieved good results. I have not heard of a study evaluating the satisfaction rate and efficacy of D2C aligners. Similarly, I have not heard of a study for treatment with Invisalign or with braces. There can be many, many patients who have tried D2C aligners and given up, accepted less than desirable results, gone to their dentist or orthodontist for continued treatment, etc. We do not know. D2C aligners have made a place for themselves in orthodontics and dentistry whether dentists and orthodontists like it or not. However, I do take exception that you as a well regarded consultant can now be quoted that Smile Direct Club has a 99.5% satisfaction and efficacy based on the information you provided.

    • Burleson Seminars says:

      Hi Mike,

      I’ll never forget one of my favorite biostatistics professors in dental school. He would laugh with our class when he said, “33 percent of all statistics are false.” I need to improve my writing skills if the point you took away from this article was the 99.5% efficacy bit.

      You’re nibbling around the big idea though. We don’t know what we don’t know, so it’s disingenuous when orthodontists lead with alarming statistics about patient harm.

      If I told you, “Half of all auto mechanics in the United States have seen damaged tires on cars driven on the interstate last month,” at face value it might seem like you should avoid highways at all costs.

      In reality, Americans drove 274.8 billion highway miles last month (source: US Department of Transportation). It would be almost impossible to draw conclusions from a small sample size (e.g., auto mechanics) versus the overall traffic volume. That was my argument and a fact orthodontists must consider before repeating these sensational stats.

      I appreciate your kind words and the thoughtful debate. I’d like to highlight the assumption that D2C aligners have “made a place for themselves in orthodontics and dentistry.”

      That’s too often how incumbents think. (i.e., Who invited these upstarts to our table?) Instead, the truth is that consumers made a place for D2C aligner alternatives at their table (i.e., free market) because of things they don’t like about traditional in-office orthodontics. I’m glad D2C aligner companies are here, shining a spotlight on orthodontics so that we can all move forward, innovating new ways to serve the consumer with excellence and increase access to care.

      Competition is good. Doing things differently is not inherently bad. If we can start with these basic assumptions, I think we can help all stakeholders thrive. It’s a huge marketplace. I’m just one little island of resistance in a big sea of orthodontics. I’ll sound my little foghorn from time to time, trying to alert you to any storms on the horizon.

      Resisting free market forces is one thing. Refusing to learn from them is another. This is our chance to learn. Let’s not squander it trying to silence everyone who disagrees with us.


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