Direct to consumer orthodontics arrives in the UK!
Direct to consumer orthodontics has travelled from the USA to the UK. I thought that I should have a look at this method of delivery or promotion of care. I will concentrate on the viewpoint of the regulation of dentistry.
Smile Direct Club and Invisalign stores are new developments in orthodontic treatment provision. Importantly, they both start the process of orthodontic treatment without a person seeing a dentist. However, they use different methods. As a result, I am going to spend some time looking at their practices.
Smile Direct Club
This is a direct to consumer orthodontics providing organisation. They offer treatment with clear aligners at a cheaper rate than orthodontists and dentists. In short, a person who wants treatment with their appliances can take impressions of their teeth using a kit sent to their home. Alternatively, they attend a Smile Shop. At the Smile Shop, they are seen by a member of staff who looks in their mouth and discusses treatment with them. If they are suitable for treatment, they take a scan of their teeth. The staff member then submits the scan and any other information to SDC. Then a registered dentist or orthodontist approves the aligner treatment plan. They then post the aligners to the patient who starts their treatment. The registered dentist then monitors the tooth movements remotely. It appears that at no point does the patient have a direct face-to-face consultation with a dentist.
Invisalign Pop Up
This model is different. A person who is interested in Invisalign treatment attends the pop-up store. They see a member of staff who discusses Invisalign treatment with them. If the person is suitable for Invisalign treatment, they are referred to a local dentist or orthodontist provider for further assessment and treatment. It is not clear if the member of staff looks at the patient’s teeth. I will return to this later.
What is the legal position?
Several people have raised questions on the legality of direct to consumer orthodontics. This is because the initial contacts in the stores are not always registered health care professionals.
In the UK Dental Care is regulated by the General Dental Council (GDC). In the past, I have been a member of the Board and the Chairperson of the GDC. As a result, I am very familiar with the regulation of dentistry in the UK.
I want to address several points. Firstly, UK regulation is clear, a person who is not a registered dentist or dental care professional (dental nurse, hygienist, therapist, clinical dental technician or orthodontic therapist) is not allowed to practice dentistry. Secondly, if a dentist provides remote care without seeing the patient, they are still liable for that care. Finally, informed consent must be obtained.
So what do I think are the implications of this type of delivery of care?
Invisalign
In my opinion, this depends on the definition of the practice of dentistry. This means that we need to look at the role of the staff member in the store. I am not sure if they look at the teeth of a potential patient. If they do not “examine” the patient there are no issues. However, if they look in potential patients mouths and have a conversation on their suitability for Invisalign treatment. This is, arguably, the first stage of orthodontic care. In effect, they may be practising dentistry. Nevertheless, this is open to interpretation, and it will depend on the viewpoint of the regulator.
Smile Direct Club
I think that this is clearer. The staff member looks at persons mouth and then takes a scan. This is then sent for planning (by a dentist) and appliance construction. If the staff member is not a dentist, then this may be the illegal practice of dentistry. Even if they are a dental nurse, they can only take impressions under the prescription of a dentist. Importantly, if they took impressions, they would be putting their registration at risk.
Furthermore, it is also clear that the dentist who approves the treatment plan is liable for that care and is responsible for informed consent. The GDC is clear on this, and they state
“You must ensure that the patients understand the decisions that they are being asked to make”.
In my opinion, this cannot be done remotely without a direct conversation with the patient.
Is this important?
In my academic and clinical opinion, I feel that this is very important for the protection of the public. I think that the Smile Direct Club issues are apparent, as the patients are not seeing a dentist. This is less clear with Invisalign because a dentist is providing the treatment. I am very interested in seeing the viewpoint of the General Dental Council on these models of delivery of care. If they make a statement or take action, I will discuss this again on my blog. The British Orthodontic Society have made a comment in response to me showing them this post and I have put it in the comments section.
Emeritus Professor of Orthodontics, University of Manchester, UK.
Smile Direct Club and Invisalign Pop Up store arrive in the UK!
British Orthodontic Societies Response (BOS) to Kevin O’Briens blog, by Peter J McCallum, Director of External Relations.
BOS welcome the invitation from Kevin to comment on his blog. The Society are very concerned about this new development ‘direct-to -consumer’ or “DIY” orthodontics. The Mission Statement of BOS is:
The Society strives to promote the study and practice of orthodontics, to maintain and improve professional standards in orthodontics and to encourage research and education in orthodontics. In doing so, BOS seeks to improve the quality of medical care for the benefit of patients. The charity’s ultimate beneficiaries are therefore patients, and benefits to patients are provided through the advancement of knowledge, practice and standards in the specialty.
We do not have any legislative powers to prevent the illegal practice of dentistry or orthodontics.
As Kevin has indicated, there is a difference between the two models he has commented upon. BOS have also made detailed enquiries about both of these models.
Invisalign Connect appear to be ‘pop ups’ which provide information to the general public about the Invisalign product. Our understanding is that they do not engage in any clinical activity or examine the patient’s mouth. They do have representatives who discuss the method and provision of treatment and provide details of a few local Invisalign providers who are registered with the GDC. The orthodontist, or dentist, to whom the patient attends is then responsible for their clinical assessment to determine their suitability for orthodontic treatment. This, of course, includes dental fitness, appropriateness for treatment, their understanding of treatment options together with the potential outcome and informed consent. Ultimately, the provider of treatment has contact with the prospective patient and is responsible for their care.
This model is based on direct contact with patients and engages in a similar way to Invisalign’s website. The website has a “doctor locator” which is a map of Invisalign trained orthodontists in the UK. It is a form of marketing which may sit uncomfortably with some, but as far as we understand is not the illegal practice of dentistry.
The second model involves care being provided remotely. The main players in this area organisations such as Smile Direct Club, Franksmile, Straight Teeth Direct, Straight My Teeth, Your Smile Direct, Smile Kit, Happy Brace have a different modus operandi. Our understanding is similar to the way Kevin describes. We understand that here a dentist will be making decisions and prescribing treatment for each patient remotely. No assessment of dental health appears to have been undertaken and therefore in our view, is impossible for that remote dentist, to know whether the patient has any underlying health issues including periodontal disease, caries or other oral health problems. BOS are not aware of how informed consent can properly be obtained or how the prescribing dentist is able to determine whether treatment is appropriate. Based on the information we hold about how these businesses work, our concern is that patients’ health may be put at risk.
Two models exist to obtain patient records with this type of direct-to-consumer orthodontics. The first is where patients take their own impressions. This would appear to circumvent the rules on impression taking which govern the illegal practice of dentistry. The second is where the patient attends a store to have a scan undertaken. Our view is that unless a qualified dentist is present and prescribes that scan, the person carrying out the scan is undertaking the illegal practice of dentistry.
Experience from the USA
According to recent media reports, “The American Dental Association and American Association of Orthodontists have asked the Food and Drug Administration, which regulates aligners, to sanction SmileDirect for treating prescription medical devices like an over-the-counter product. The FDA hasn’t taken action.” Bloomberg Aug 22, 2019. Several States are taking action to prevent scanning without a dentist present
BOS are very concerned about the development and increase in the provision of direct-to-consumer orthodontics. We cannot legislate against this practice. The fundamental issue is the protection of the public. BOS’ view is that unless a registered dentist examines the patient and discusses all the issues involved with the provision of orthodontic treatment, the safety of the public is at risk. We are currently preparing and will be embarking on an educational campaign with the Oral Health Foundation to inform the public about the risks of direct-to-consumer orthodontics.
BOS cannot bring legislation against this practice as we are a charity and not the regulator of the dental profession. We implore the dental regulator, the General Dental Council, whose “primary purpose is to protect patient safety and maintain public confidence in dental services”, to investigate the practice of direct-to-consumer orthodontics as a matter of great urgency.
Hi Kevin, great to read your posts as always.
I was wondering, since the concept of direct-to-consumer orthodontics is not new (SDC have been around for about 5 years I believe, with hundreds of thousands of treated cases), has there been any scientific research into the outcomes/ or risks/benefits of this model of orthodontic care?
Obviously, a lot of the literature coming from orthodontists and associations has been negative, and conceptually it’s easy to see why, but do we have the science to back up the argument that teledentistry puts patients at risk?
Joey
At first glance this would seem to have parallels with tooth whitening and also things like botox, all cosmetic enhancements. One would suspect that if aligning teeth were not a cosmetic procedure then this would not be happening. Thus saying it does differ from other cosmetic procedures such as tooth whitening in that there are quite a few things that can go wrong. These can occur in 3 areas, planning, treatment and retention.
Planning often needs an opt and other radiographs and a discussion. I often get strange looks when I tell colleagues that I spend a lot of time talking patients out of treatment as if that’s the exact opposite of what I should be doing. I hope that I’m not the only one but it feels a bit like it, so I suspect there might not be too much discussion with patients using these systems to advise that maybe they should leave their minor malocclusions alone (mainly because the teeth will move back or they look good already).
During treatment the teeth might not move etc. Also IPR appears to be necessary in many cases.
Retention requires retainers, often bonded, somebody has to look after these and fit them.
I can see the invisalign method working since all it is is direct advertising, as long as they do not attempt diagnosis at the pop up visit.
The smile direct method is more problematic and, as an orthodontist, I wouldn’t want to be associated with it as described, but that’s just me. Presumably they have someone to do the ortho diagnosis already and to that or those people I would say, just think of all the things that could go wrong and that you will be liable for, sooner or later.
Like Kevin and I have grave concerns about “do it yourself” orthodontics.
A couple of weeks ago I filled in an online form and was deemed suitable for “Smile Direct” treatment having answered a few simple questions, and I was invited to Manchester to have a scan. Alternatively for £37 I could be sent an self impression kit. Since then I have received a barrage of emails encouraging me to respond and offering discounts on the original quoted price.
Clearly there has been no general dental examination or adequate orthodontic assessment of my teeth and no discussion of the various options open to me, such as no treatment (which has served me well for nearly 70 years).
Over the years I have been involved as an expert witness on both sides of the fence in GDC Professional Conduct Committee cases and if, in such circumstances, I was asked whether a registered dental professional involved in the assessment and planning I have described above was practising at the level that meets the standard, or was far below the standard expected reasonable body of dental professionals, I would have no hesitation in believing that they were practising far below the standard expected. Also, there would be significant risks to the patient which I am sure would concern the Committee greatly. I would advise that any dental professional considering becoming involved in this form of do-it-yourself orthodontics should reflect seriously both on the risks to which they may be putting their patients and also the significant risk to their own professional future.
What are the actual risks to the patient though?
This is the beginning of the end of Orthodontics as a profession. Are you surprised? Orthodontics should be considered the specialty in the specialty and practiced only by qualified professional. Aligners in general are not professional instruments. And there is still polemical discussions on functional treatments? Give me a break!
Another issue
Any treatment able to has a complication…
What if any one of this direct to consumer orthodontic patients suffer any type of complication , how can the remote dentist solve it ??
No need to talk about the ethical aspect of this ( treatment ) it’s absolutely unethical
Hi Kevin,
On a more basic issue about scanning : is the scanned 3D images (be it a scanned intra-oral image or study cast) admissible evidence in UK courts?