The Concerns & Risks of Direct to Consumer Aligners by Dr Arti Hindocha
All over the world, direct-to-consumer aligner companies are enticing hundreds of thousands of patients into signing up with appealing, well-designed and marketed adverts on social media and television. They present direct-to-consumer aligners (hereafter known as DTC aligners) as an easy-to-attain, affordable treatment option, with a cheaper price by “cutting out the middle-man”- namely dental and orthodontic clinics. In some parts of the world, networks have been set up where a patient can actually access a dentist but only if partnered with the DTC aligner company. As far as I am aware in the U.K. and EU this is not the case and patients are left to fend entirely for themselves.
In a survey conducted by Wexler et al., (2020), it was concluded that, “Though many respondents would have preferred traditional treatment from a dentist or orthodontist, they opted for DTC aligners because of cost and convenience”. This has us asking, what can we do to guide the public to make sure their health and well-being is protected? How are patients giving informed consent to be treated with DTC aligners, without face-face interaction with a trained dental professional or orthodontist? How did GDC Standards fall by the wayside, and how are contemporaneous notes made if teledentistry is being carried out?
According to GDC Standards, GDC Standard 4.1 states: You must make and keep contemporaneous, complete and accurate patients records; GDC Standard 4.1.1 clearly states: You must make and keep complete and accurate patient records, including an up-to-date medical history, each time that you treat patients. Radiographs, consent forms, photographs, models, audio or visual recordings of consultations, laboratory prescriptions, statements of conformity and referral letters all form part of patients' records where they are available.
It’s safe to say most of us are not worried about being undercut. There will always be patients who need orthodontics; there is more than enough work for dentists and orthodontists who wish to carry out aligner treatments. Our fears as orthodontists are over the compromised safety of patients and the public. DTC aligner companies are even promoting treatment in adolescents as young as 12 years old. Dentistry without the correct supervision is unsafe, it is only a matter of time before other specialities will be affected by DTC products, if not already.
The 3 main concerns regarding DTC aligners:
Lack of Patient Education
A growing number of patients are informing their dentist they are interested in signing up for DTC aligners, with no idea of the risks. Recently, a peer shared with me a conversation she’d had with a patient who thought that DTC aligner providers and well-known aligner providers worked in the same way. The patient asked, “It’s the same thing, right?”. Patients do not understand that some established aligner companies do work alongside dental and orthodontic clinicians, who always carry out a thorough face-to-face dental and orthodontic assessment and that regular appointments are required for a reason. Assessments will include an oral cancer screening, screening for caries and periodontal disease, an orthodontic assessment and radiographs where necessary, all before an orthodontic treatment plan is created. Radiographs act as an adjunct to diagnosis; they allow us to check bone levels, temporomandibular joints, caries, impacted teeth, root length/shape/form, periapical pathology, previously traumatised teeth, and root resorption.
The review appointments allow for course correction and reassurance that treatment is going to plan.
Dental Problems Pre and Post-treatment
Although published studies on this trend are currently limited, the growing number of patients following a course of aligners from direct-to-consumer companies are not happy with their results; some have gained complications and are even experiencing pain or discomfort. Many clinicians are anecdotally noting that the creation of an anterior open bite seems to be one of the leading complications due to occlusal interferences on posterior teeth. Other cases may include varying degrees of root resorption, tooth mobility, and worsening of caries leading to root canal treatments. Worst-case scenarios include loss of teeth and poor end results often needing re-treatment with specialists. Moreover, let’s consider those DTC patients who are not on any dentist’s register. By bypassing a face-to-face consultation with a dentist or orthodontist, this group of patients may not have any damage recognised until it is too late. Please note not all patients will experience this and orthodontists/dentists can also misdiagnose and mistreat.
The Dental Industry’s Reputation
As more members of the public become dissatisfied, the reputation of the dental industry could be compromised. A positive perception of the whole clinical dental/orthodontic team and all regulatory boards needs to be upheld in the public eye. Our reputation of putting patient wellbeing and safety first needs to be maintained.
What are the risks to patients of direct-to-consumer aligner products?
Patients are often required to take their own impressions or visit a shop for an intra-oral scan, and treatment eligibility is determined without radiographs. Companies that provide DTC aligner treatments may have clinicians on their team, however, they may only see patients in a video call and not face-to-face. Without a full face-to-face consultation before, during and after treatment, patients also may not get all the right advice, give informed consent, or engage fully to get the most out of their treatment. Orthodontic treatment has risks, and informed consent is vital for patient engagement and awareness of any limitations in treatment. Retention is a key part of this discussion as patients often don’t grasp how important it is to retain the new position of their teeth. An orthodontist/dentist will not provide orthodontic care until active decay or periodontal issues are treated and stabilised. Some treatment plans will require interproximal reduction (IPR) which must be carried out in some cases to make space for tooth movement. Patients don’t often understand the risks of IPR, why it is required or even what it is. This needs to happen in an orthodontic or dental clinic. It is an irreversible procedure and needs to be consented for properly. DTC aligner companies place the responsibility of this on patients to seek out a dentist to do this for them. Does this mean the responsibility of the case is now in the hands of another clinician who didn’t plan the case?
Limited Treatment Outcomes
Receiving aligners in the post means patients don’t get to try them on beforehand. If patients are taking their own impression, how are they quality checked? This creates a risk of aligners that don’t fit properly; leading to pain and discomfort and affecting patient compliance. The limited number of academic studies on DTC patients means data on this is currently scarce. When orthodontists plan cases it is systematically with Newton's 3rd law in mind, "every action has an equal and opposite reaction”. When limited objective treatments are planned there are always consequences to treating one part of the bite only, who is explaining this to the patient?
Not Always Cost-Effective
Although a dentist is said to be assigned to a case, are they planning the case? Is this dentist readily available to deal with any compromised outcomes, and available to answer all the patient's questions? Access this testimony from a doctor who previously worked for a DTC company https://www2.aaoinfo.org/wp-content/uploads/2021/09/AAO_DTC-Testimony-2021-2.pdf.
The biggest selling points DTC aligners have are the extremely attractive low prices and convenience of avoiding multiple visits to a dental/orthodontic practice. However, if the treatment doesn’t go to plan, or the patient develops complications, they will most likely have to visit a dentist/orthodontist anyway, incurring more costs in the long run. Those that realise halfway through treatment that they are unhappy and wish to stop treatment and refuse to keep up with their payment plan then have their credit score affected. In order to get a refund, patients may need to sign non-disclosure agreements to get their money back, and have difficulties contacting any representative. Patients are also unaware of the high-interest charges - up to 17% on monthly payments, and ‘hidden fees’ they may have to pay.
In worst-case scenarios, patients may even require jaw surgery to correct their problems comprehensively. This will all be at a greater cost to the patient.
What is the European Federation of Orthodontic Specialists Association (EFOSA) and how is it helping?
EFOSA represents over 11,000 orthodontists in Europe. It has member representatives from most European national societies of professional orthodontic associations. EFOSA supports high standards of training for orthodontic specialities and promotes a high quality of care provided by orthodontic specialists within the U.K. and EU. EFOSA also spreads patient and public awareness of orthodontic treatments and modalities.
As Secretary of EFOSA, I am pleased to share that a “Joint Declaration” was created in October 2021, accompanied by a press release, to highlight the growing sentiment of concern from EFOSA members surrounding DTC companies. The Declaration is endorsed fully by EFOSA and pioneered by Chris Scherer, Treasurer of EFOSA. The press release given out by EFOSA, states, “31 professional dental and orthodontic societies, associations, and institutions from 25 countries have come together to endorse and fully support a Joint Declaration regarding this unacceptable and potentially unsafe remote treatment of malocclusions. This Declaration clearly states the basic requirements that must be met for any orthodontic treatment.”
The Declaration, consisting of four key points, states that orthodontic treatment must be carried out by a fully qualified dentist/orthodontist and establishes that orthodontic treatment is potentially dangerous for the patient's health without thorough face-to-face clinical examinations; evaluation of imaging findings(radiographic findings), and regular clinical follow-ups.
On 17th May 2021, Stephan Gierthmühlen (2021), a Specialist Lawyer for Medical Law, gave a damning statement about DTC aligner companies in a public hearing before the German Committee on Health (German Bundestang). The statement titled, “Ensure patient safety during aligner treatments” was written on behalf of the Berufsverband der Dutchen Kieferorthopaden, (BDK), the German association representing the political interests of orthodontics. The statement explained how DTC aligner companies had managed to become successful in the public eye so quickly, how DTC companies operate with an impairment to patient safety, and how the insufficiency of existing regulations had enabled an unheard-of business model within healthcare, and his recommendations to promote patient safety. Stephan’s statement highlights that the global dental industry is well aware of the reality that positive action must be taken sooner rather than later to protect patients. This statement, referenced below, is available on request.
At the EFOSA General Annual Meeting during the European Orthodontic Conference in Limassol (June 2022), opportunities on how different countries can collaborate to protect current and future patients were discussed. EFOSA members shared information and resources, and are willing to share these with GDPs and the public. Many countries are already making headway. Representatives from America, France, Germany and Spain discussed how they have used the Joint Declaration (EFOSA), marketing and TV advertisements to spread awareness and the message to the public. Regulatory bodies and governments are being approached in different countries and the right people are starting to listen.
What can we do in practice right now?
If a patient queries DTC treatment and is keen to start; explain why the cost of care from a dental or orthodontic clinic is so different. Emphasise that follow-up appointments are included to prevent treatment from taking longer than it should and highlight if treatment is going off track. Radiographs, caries and periodontal checks, and oral cancer screenings do not always come as part of the package with DTC brands; explain the importance of thorough records.
Publish the British Orthodontic Society (BOS), General Dental Council (GDC) and American Association of Orthodontists (AAO) statements on your websites and social media accounts. Publish links to AAO orthofacts.orgpage to give patients further information about Myths vs Facts of DTC aligners.
Use posters (available on AAO orthofacts.org), use the TVs in your waiting room to educate patients on the differences between DTC orthodontics, and orthodontics through an orthodontic/dental clinic.
Follow EFOSAorthodontics on Instagram to see the Joint Declaration, patient information on DTC companies, and keep up-to-date with matters affecting dentists and orthodontists practising orthodontics in the U.K. and EU.
Encourage the whole team to get involved in the discussion about DTC products, their dangers and what resources are available for patients.
What resources are available for clinicians?
https://www.bos.org.uk/News-and-Events/BOS-Statements/BOS-Statement-Do-it-yourself-braces (British Orthodontic Society)
https://www.gdc-uk.org/standards-guidance/standards-and-guidance/gdc-guidance-for-dental-professionals/direct-to-consumer-orthodontics/gdc-statement-on-direct-to-consumer-orthodontic-treatment(General Dental Council)
www.orthofacts.org(American Association of Orthodontists)
Follow EFOSAorthodontics on Instagram, and contact us with any ideas/suggestions or questions.
Help patients make an informed choice
Teledentistry and remote dentistry do have a place in this new world, especially if applied correctly and in the right circumstances.
It has been said time and time again, that DTC companies are here to stay. Thankfully, so are EFOSA and all the orthodontists and dentists who will continue to put patient safety first. We will continue to work together to educate patients so that they can make an informed choice of where and how they choose to have their orthodontic treatment.
Wexler A, Nagappan A, Beswerchij A, Choi R. Direct-to-consumer orthodontics: surveying the user experience. J Am Dent Assoc. 2020 Aug;151(8):625-636.e4. doi: 10.1016/j.adaj.2020.02.025. PMID: 32718492; PMCID: PMC7391059.
Gierthmühlen, S./ Berufsverband der Dutchen Kieferorthopaden (2021) Ensure patient safety during aligner treatments. Available at: The document is available on request (Accessed: 07,2022).
About Arti Hindocha
BDS(Hons) MJDF RCS (Eng) MClinDent M.Orth RCS(Eng) FDS Orth RCS (Eng) C.I.L.T
Arti Hindocha qualified with Honours from King's College London (2009). She specialised in orthodontics at Eastman Dental Institute and Kettering General Hospital obtaining her MClinDent (UCL) on intra-oral scanning and M.Orth from the Royal College of Surgeons England (2015, 2016). She completed a further two years of higher orthodontic training at the Royal London Hospital and William Harvey Hospital; qualifying as a consultant in 2018, with her Fellowship in Orthodontics from the Royal College of Surgeons. She is currently a consultant orthodontist at Kettering General Hospital and works in 2 private practices in Wimpole Street and Northampton. She is passionate about teaching undergraduates and postgraduates, in her free time she supports and mentors GDPs who have an interest in orthodontics.
She is a member of the British Orthodontic Society, British Lingual Orthodontic Society, and the European Orthodontic Society. She has been President of the European Postgraduate Student Orthodontic Society (EPSOS), Postgraduate Representative on the Royal College of Surgeons Board, and is currently on the Northants Local Dental Council and Secretary of the European Federation of Orthodontic Specialists Association (EFOSA). She lectures locally, regionally and internationally.
The views stated in this article are the views of Dr Arti Hindocha, Arti is working in partnership with DB Orthodontics to raise awareness of good IPR practices for GDPs and orthodontists carrying out both fixed and aligner treatments, as part of a thorough care plan. Her recent presentation “Interproximal Reduction: Best Practice in Easy Slices” offers a comprehensive guide to IPR, including the benefits of a minimally invasive approach.
Click here to view DB Orthodontics’ latest Aligner Essentials Booklet featuring mechanical calibrated IPR kits and manual IPR products.