Direct to consumer aligners: how do we support patients?

Direct to consumer aligners: how do we support patients?

Consultant orthodontist Arti Hindocha highlights the concerns and risks surrounding direct-to-consumer aligner products.

She also discusses what steps the European Federation of Orthodontic Specialists Association (EFOSA) is taking, and what we can do right now in the UK to help educate our patients to make informed choices.

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. 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 UK and EU this is not the case. Patients are left to fend entirely for themselves.

In a survey (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’.

Protecting health and wellbeing

This has us asking, what can we do to guide the public to make sure their health and wellbeing is protected?

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, for example. 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 three 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.  They always carry out a thorough face-to-face dental and orthodontic assessment. Regular appointments are required for a reason.

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. 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. Therefore a positive perception of the whole clinical dental/orthodontic team and all regulatory boards needs to be upheld in the public eye.

So 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?

No/limited consultations

Patients are often required to take their own impressions or visit a shop for an intra-oral scan. 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. Informed consent is vital for patient engagement and also 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. But 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

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. They may have difficulties contacting any representative. Patients are also unaware of the high-interest charges. They could be charged up to 17% on monthly payments.

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 UK and EU. It also spreads patient and public awareness of orthodontic treatments and modalities.

Making headway

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 Declaration, consisting of four key points, states that orthodontic treatment must be carried out by a fully qualified dentist/orthodontist.

It 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.

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
  • Also highlight if treatment is going off track. Radiographs, caries, 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 also the American Association of Orthodontists (AAO) statements on your websites and social media accounts. Publish links to AAO page to give patients further information about myths vs facts of DTC aligners
  • Use posters (available on AAO Use the TVs in your waiting room to educate patients on the differences
  • Follow EFOSA orthodontics on Instagram to see the Joint Declaration. Keep up to date with matters affecting dentists and orthodontists practising orthodontics in the UK 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?

  1. (British Orthodontic Society)
  2. (General Dental Council)
  3. (American Association of Orthodontists)
  4. Follow EFOSA orthodontics on Instagram, and contact us with any ideas/suggestions or questions.

For information on DB Ortho visit

For references email [email protected]

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