Dentistry.co.uk explores the rise of direct-to-consumer orthodontics – what does the term mean, is it safe and does the dental profession support it?

What are direct-to-consumer orthodontics?

Direct-to-consumer orthodontics refers to any orthodontic treatment for which appliances are sent directly to the patient’s home. It can involve in-person appointments or scans but is often conducted entirely remotely. The most common direct-to-consumer provision is tooth straightening through clear aligner treatment.

Several services have offered orthodontic treatment on a direct-to-consumer basis in recent years. The most well-known of these, Smiledirectclub, ceased to operate in 2023. More information on Smiledirectclub and its closure can be found below.

According to the General Dental Council (GDC), direct-to-consumer orthodontic services fall within the legal definition of dentistry and can only be performed by a GDC-registered dental professional. Direct-to-consumer orthodontics are therefore legal as long as a GDC-registered dental professional provides ‘safe and effective’ care to the patient.

What are the GDC requirements for providing direct-to-consumer orthodontics?

Assessment of oral health

The GDC states that it is possible for many dentist-patient interactions to be provided on a remote basis ‘in full compliance’ with the Standards for the Dental Team.

However, the regulator also stresses that clinical judgements surrounding orthodontic treatment should be based on ‘a full assessment of the patient’s oral health’. It says: ‘At present, there is no effective substitute for a physical, clinical examination as the foundation for that assessment.’

The GDC therefore concludes that ‘a face-to-face interaction or a physical clinical assessment will be necessary to ensure patient safety’ in many cases.

That said, clinicians operating remotely may be able to rely on information from another dental professional. For example, patient records from previous clinical exams. The GDC emphasises that the responsibility for any clinical judgments based on information from another dental professional still rests entirely with the prescribing dentist.

Direct contact

In addition to assessing the patient’s oral health, the GDC requires orthodontists working on a direct-to-consumer basis to interact directly with patients. This could be either in person or remotely, but the patient must know the name of the treatment provider and be able to contact them. Direct contact allows patients to provide valid and informed consent, and to ask any questions they may have.

Meeting standards

Overall, the GDC asks dental professionals to remember that they are responsible for ensuring that they are meeting the Standards for the Dental Team. The regulator highlighted several of the standards that might be harder to meet through a direct-to-consumer model. These are:

• Standard 1.4 and 7.1 – a holistic, individual approach based on current evidence and authoritative guidance
• Standard 2.1 – effective communication
• Standard 3.1 – valid consent throughout treatment
• Standard 2.3.1 – introducing yourself and facilitating direct contact
• Standard 4.5 – keeping patients’ information secure
• Standard 5.1 – having an effective complaints procedure.

What issues could arise from direct-to-consumer orthodontics?

‘I wouldn’t even categorise direct-to-consumer teeth straightening treatment as “orthodontics”.’

Nina Shaffie

Specialist orthodontist

Speaking to Dentistry, specialist orthodontist Nina Shaffie explained some of the potential risks of a direct-to-consumer model.

She said: ‘An important key to successful orthodontic treatment starts with a detailed orthodontic and oral health assessment and diagnosis. By eliminating an in person detailed assessment with a suitably qualified clinician, patients enter a treacherous journey and unknowingly become blindsided by all the risks that unsupervised teeth straightening can pose.

‘During my career, I have had to rectify many such treatments where patients have been left with poor bites, teeth that have been pushed outside of the biological limits of the bone, and sadly patients who have had irreversible and permanent damage to teeth and bone health. They were left worse off than when they started and left out of pocket.

‘One could argue that patients should take some responsibility for their own health and not seek treatment from such companies that conduct business under the umbrella of dentistry.

‘However, to the untrained eye these companies often appear to operate legitimately. This is far from the truth. There is a clear disregard for the regulations set by the GDC and a complete lack of informed consent, which are all set in place to protect the patients from harm.

‘I see no benefit in direct-to-consumer treatment, apart from lower costs and more use of remote planning and monitoring, which a lot of practices already adopt to enhance patient experience and convenience. Most practices also offer affordable payment plans.’

Does the dental profession support direct-to-consumer orthodontics?

Many individuals and organisations within the dental profession have commented on the viability of a direct-to-consumer model of orthodontics.

British Orthodontic Society

The British Orthodontic Society (BOS) describes itself as ‘extremely concerned’ about direct-to-consumer orthodontics. It provides three reasons:

1. ‘A full clinical examination by a trained clinician is necessary to decide if orthodontic treatment is in the best interests of an individual’
2. ‘There are a number of different types of orthodontic appliance with different advantages and risks. Those considering braces need to be aware of the choices available to them and also to understand the risks of treatment’
3. ‘Unsupervised treatment may result in a suboptimal outcome and the need for further treatment, or in the worst case scenario, cause permanent damage to dental health.’

The society strongly advises the public against using direct-to-consumer services. Instead, the BOS suggests they see an experienced orthodontist in person. It says: ‘Seeing an experienced clinician will allow treatment to be carefully monitored and ensure that should any problems arise these are quickly addressed.’

BOS director of external relations Anjli Patel told Dentistry: ‘We are fully behind using the latest technology such as video consultations and remote monitoring to ensure an enhanced patient journey.

‘However, before embarking upon any course of orthodontic treatment, the patient must undergo a full clinical examination by a dentist or orthodontist.

‘Clear aligners are a fantastic tool in our armoury. But they are not the answer to all clinical needs. If you only have a hammer, everything can look like a nail.’

Dental Defence Union

Several dento-legal issues surrounding direct-to-consumer orthodontics have been identified by the Dental Defence Union (DDU). In particular, the DDU says that being approached by patients to judge the suitability of proposed direct-to-consumer treatment could leave dental professionals legally liable.

The union emphasises that dental professionals are responsible for any opinions provided. It says: ‘It may be advisable not to comment on the specific treatment offered. You can, however, discuss with them the general options for orthodontic treatment with a qualified clinician.’

The DDU also suggests professionals ‘explain the benefit of making sure any proposed orthodontic treatment the patient embarks on is suitable for their individual circumstances, and that any underlying oral health problems are considered in detail’.

Finally, the union advises dental professionals to keep a record of any conversations around direct-to-consumer orthodontics and contact its dento-legal advisers if any issues arise.

Dental professionals

Direct-to-consumer orthodontics have faced a great deal of criticism from dental professionals working with traditional treatment models.

Specialist orthodontist Emma Laing told Dentistry: ‘I cannot see how you can purchase these appliances with home impressions and gain anywhere near the standard of care that you receive from a dentist or orthodontist in-surgery. Even if direct-to-consumer companies have some clinicians involved in the treatment planning.’

Many dental professionals have emphasised the need to assess a patient’s oral health status before proceeding with aligner treatment.

Dentist Chloe Harrington-Taylor said: ‘If forces are applied to teeth with underlying disease such as decay or gum disease, patients risk losing teeth. It would be like trying to build a house without stable foundations – the house would eventually fall down!’

While acknowledging the appeal of the reduced costs, dentists stress that patients may end up spending more in the long run to correct mismanaged treatment. Dentist Chinwe Akuonu said: ‘I genuinely do not believe that patients are saving any money whatsoever by taking on these trends. Instead, they are risking their oral health and it’s definitely not worth it.’

Some direct-to-consumer companies have adopted a hybrid approach, delivering aligners to patients’ homes alongside in-person appointments. However, this has not been received wholly positively within the dental profession.

Nina Shaffie said: ‘I would not be comfortable taking responsibility and being involved in any aspect of such treatments. As healthcare professionals in the UK, we have a certain level of responsibility and duty of care to patients.

‘Therefore, I cannot support a system where the patient have not had correct diagnosis and treatment plan, are not being monitored adequately and are lured into treatment under false pretences – while being completely unaware of the risks to their health.’

Smiledirectclub

What is Smiledirectclub?

Smiledirectclub was a popular direct-to-consumer orthodontics service. It launched in the UK in 2019, delivering clear aligners to patients’ homes without any in-person consultation. Prior to this the company had treated 650,000 customers in US since 2014.

Co-founder Alex Fenkell said: ‘Our mission is to help people unleash the power of their smile and positively impact their place in the world. The confidence that comes from having a great smile is transformative to every aspect of your life.

‘Through our groundbreaking teledentistry platform, we’re giving more people access to affordable smile care. The time is right to expand our mission to the UK to give more Britons the confidence that comes from a straighter, brighter smile.’

The company said it would employ more than 300 people in the UK, including dentists, orthodontists and dental nurses.

How did Smiledirectclub work?

1. Consultation

Patients had the option to begin their consultation online or in-person at a high street shop. Smiledirectclub initially launched nine storefronts across London, Birmingham and Manchester.

2. Scanning

At physical locations, patients received a digital intraoral scan free of charge. However they also had the option to complete a physical impression kit, which was mailed to their home. This option was entirely remote and did not involve the input of Smiledirectclub staff.

3. Treatment plan

A licensed dentist or orthodontist reviewed the scan or impressions and created a treatment plan. The identity and location of these professionals is unknown.

4. Treatment

Custom clear aligners were fabricated through 3D printing and posted to customers’ homes. Patients were instructed to wear the aligners for roughly 22 hours per day. This accounts for removal for eating, drinking, brushing their teeth and flossing.

5. Follow-up

Every 90 days, patients could visit the Smiledirectclub website to make contact with their assigned provider. They would then receive a new set of aligners.

6. Retention

After their treatment plan was completed, customers would receive a retainer to maintain the alignment of their teeth.

Controversy

In 2020, Smiledirectclub CCO Jeffrey Sulitzer was subject to a two-year investigation by the Dental Board of California. The state accused him of ‘aiding and abetting’ Smiledirectclub in the unlicensed practice of dentistry.

Smiledirect club said the allegations were ‘unfounded and untrue’. It said: ‘The baseless claims in the accusation are entirely without merit.’

The American Association of Orthodontists also complained against Smiledirectclub, leading to an investigation by Florida’s dental board. This was closed without consequence.

Smiledirectclub said: ‘We are pleased that the Florida Board of Dentistry has rejected and closed the American Association of Orthodontists’ complaint against Smiledirectclub. This verifies that Smiledirectclub is operating in full compliance with Florida law.’

The teledentistry company has also been subject to criticism of its UK operations. In December 2023, the British Dental Association (BDA) claimed that Smiledirectclub’s 65,000 patients were supervised by ‘just five UK-registered dentists’.

BDA chair Eddie Crouch said: ‘It beggars belief that five dentists would be enough to provide continuing care for the company’s reported 65,000 UK patients. It shows why change is needed, so that the public are protected, and corners are not cut.’

Eddie Crouch also questioned Smiledirectclub’s lack of in-person consultations. He continued: ‘A full clinical assessment isn’t a nice to have or an optional extra – it should be required no matter what. If we’re going to protect patients the basics of decent care must be in place for all.’

Speaking to Dentistry, Smiledirectclub chief clinical director defended the company’s position. He said: ‘It’s important to understand that Smiledirectclub does not treat “patients”. Smiledirectclub is a next generation oral care company that provides non-clinical administrative dental support organisation (“DSO”) services.’

He added: ‘We believe the necessity of in-person consultations are the sole discretion of the treating dentist or orthodontist and should be made on a case-by-case basis.’

What happened to Smiledirectclub?

In October 2023, Smiledirectclub filed for chapter 11 bankruptcy. The company’s solicitors said this did not mean the company would be closing down, stating: ‘The operations of the UK entity and all other international affiliated entities remain fully operational.’

However by December it was announced that Smiledirectclub would be ceasing to operate worldwide.

A company statement read: ‘Smiledirectclub has made the incredibly difficult decision to wind down its global operations, effective immediately. For new customers interested in Smiledirectclub services, thank you for your interest, but aligner treatment is no longer available through our telehealth platform.

‘For existing customers, we apologise for the inconvenience, but customer care support is no longer available. Thank you for your support and letting us improve over two million smiles and lives.’

What happened to Smiledirectclub customers?

All current orders were immediately cancelled and patients did not receive further aligners. Specialist orthodontist Emma Laing said patients were left with two options.

Firstly, ‘to stop the treatment and let the teeth relapse uncontrollably’. However she noted that this could leave teeth ‘in a more detrimental position than where they started’.

The other option would be to see a dentist or orthodontist for corrective treatment. This would need to be on a private basis as there is no scope for such treatment on the NHS.

She said: ‘This will incur much larger costs, which their patients may not to be able to afford if they sought this treatment to be economical in the first place.’

The British Orthodontic Society suggested that Smiledirectclub patients who were anxious about their treatment should consult an orthodontist or dentist at the first opportunity. It said: ‘They can be assured of professional and sympathetic care as well as an understanding ear.’

How did the dental profession respond to the closure?

The closure of Smiledirectclub brought out what orthodontist Damon Taheri described as ‘a complex mix of emotions within the orthodontic community’.

He continued: ‘On one hand, there’s a sense of relief among many of us who have long been concerned about the implications of remote teledentistry models. This situation highlights the importance of prioritising patient safety and proper dental care over profit-driven approaches.

‘However, my heart truly aches for the patients who find themselves in limbo due to this bankruptcy. These individuals sought what they thought was a more affordable and accessible way to address their orthodontic issues, and they trusted Smiledirectclub to provide a solution. Now, they are left in a state of uncertainty regarding the completion of their treatments, which is deeply concerning.’

Orthodontic therapist Chrystal Sharpe also expressed concern about the dangers of remote orthodontics. She said: ‘I firmly believe remote unmonitored aligner treatment is not comparable to bespoke clinical care, provided by dental care professionals held to rigorous standards under a regulatory body. I’m a firm advocate for regulation in the dental industry and hopeful the recent bankruptcy news will raise quality concerns to regulators.’

Dental technician Rob Kenyon drew attention to the lack of regulation of teledentistry providers compared with those using traditional models. He said: ‘The contrasting regulatory environments create an uneven playing field, putting conventional practitioners at a disadvantage.

‘They often lack the substantial financial and legal resources to challenge regulatory directives or engage in legal discourses, unlike their direct-to-consumer counterparts, who with deeper pockets can afford to navigate the legal and regulatory landscapes more aggressively.’

How to help patients following direct-to-consumer orthodontics

Dental professionals may be approached by patients who have either been left in the lurch following the Smiledirectclub closure or who are unsatisfied with the results of their direct-to-consumer treatment. Nina Shaffie offered some advice for handling these cases:

‘I have had concerns treating these patients but equally I put myself in their shoes, where it can be easy to be lured into buying online products which may seem like a good deal. I’m sure we’ve all been tempted with an Instagram ad or two and if patients are not educated then they are none the wiser and the cycle continues.

‘Raising awareness and educating patients on the dangers of such treatments is a more effective way of ending such businesses.

‘I carry out a very detailed orthodontic assessment during all of my consultations and therefore any previous complications that pose additional risk are identified and discussed with patients in detail.

‘A lot of these direct-to-consumer patients that I treated had ended up with excessive root resorption, loss of vitality of teeth, dehiscence and gingival recession as a result of excessive, uncontrolled and unsupervised forces.

‘I have a very comprehensive verbal and written consent process with patients where I discuss how to minimise and manage further complications.’

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