Sabrina Mahmood, senior associate at Keoghs, examines the legal risks arising from the growing popularity of clear aligner treatment and considers how developments in digital dentistry, remote treatment planning and artificial intelligence are creating new challenges.
There has been a significant increase in demand for orthodontic treatment using clear aligners in recent years, with Invisalign remaining one of the most widely recognised brands in the market. As digital technology continues to transform the delivery of dental care, obtaining orthodontic treatment has never been more accessible. Patients can now seek a ‘perfect smile’ from the comfort of their own home, often beginning the process with an online assessment or virtual consultation.
In 2014, Smile Direct Club emerged as a hugely popular direct-to-consumer clear aligner provider, offering patients a largely remote treatment journey. It was marketed as a more affordable and convenient alternative to traditional orthodontic care. The model enabled patients to take their own impressions, with treatment plans reviewed remotely by dental professionals (it was reported that five professionals were servicing 65,000 patients). However, the company faced significant criticism from the dental profession, with concerns raised about the remote assessments, patient suitability for treatment, the lack of involvement of a suitable practitioner as well as the management of complications. The company filed for bankruptcy and ceased operations in late 2023.
The market has since evolved and many modern clear aligner providers now seek to combine digital innovation with greater levels of clinical oversight, using artificial intelligence to support treatment planning and remote monitoring. While these technologies are marketed as decision-support tools rather than replacements for clinicians, registered dentists and orthodontists remain responsible for diagnosis, treatment planning and ongoing patient care.
Where can legal issues arise?
While clear aligner treatment is often marketed as a straightforward and convenient alternative to traditional orthodontics, the reality is that successful treatment depends on patient compliance, accurate diagnosis and suitable treatment planning as well as appropriate clinical oversight throughout treatment. As treatment pathways become increasingly digitised, there are a number of areas where legal and regulatory issues may arise.
Untreated pre-existing dental issues
In our experience, a recurring theme in claims is where there has been a failure to treat underlying dental issues or the mismanagement of those issues. For example, orthodontic treatment should not be initiated where there is active periodontal disease. If a patient undergoes aligner treatment without appropriate periodontal assessment and management, the resulting tooth movement may accelerate existing bone loss, lead to increased tooth mobility or adversely affect the long-term prognosis of the teeth.
We have seen claims where treatment may then need to be paused or re-done if the underlying dental issue needs to be resolved before treatment is completed. In addition to allegations of negligent treatment, informed consent issues may also arise. Patients may argue that they were not adequately advised about the risk of bone loss, the impact of pre-existing periodontal disease, or the likelihood of prolonged treatment involving multiple refinements.
In practice, we have seen patients argue that, had the material risks been properly explained to them at the outset, they would not have proceeded with the treatment. From a risk management perspective, it is essential that a suitably qualified clinician conducts a comprehensive review of the patient’s dental records and overall oral health before treatment is offered. This enables any underlying dental conditions to be identified and addressed, ensures that treatment suitability is properly assessed from the outset, and facilitates meaningful discussions with the patient regarding the risks, benefits and likely prognosis of treatment.
Managing expectations and informed consent
Clear aligner treatment is rarely a linear process and frequently requires one or more rounds of refinements to achieve the desired outcome (and these can take as long as the initial course of treatment). Patients are not always aware at the outset that refinements will be required, and this can become a basis for complaints. Where treatment ultimately takes significantly longer than anticipated, or where additional costs are incurred, disagreements may arise regarding whether adequate information was provided during the consent process. From a risk management perspective, clinicians should ensure that discussions regarding likely treatment duration, the possibility of refinements and any associated costs are clearly documented.
Questions of informed consent could also arise in relation to the brand of aligner system being used. Some patients actively seek treatment with a particular brand. If a patient believes they are purchasing treatment with one aligner system but subsequently receives a different product, they may argue that they were not given sufficient information to make an informed decision. Whilst dentists are not generally required to identify the brand of every instrument, material or device used during treatment, clear communication becomes increasingly important where the choice of aligner system forms part of the patient’s decision to seek treatment or to proceed with a treatment plan.
Where does responsibility lie in the digital era?
Clear aligner treatment utilises 3D modelling and printing and increasingly sophisticated digital treatment simulations. Whilst these systems provide valuable clinical support, there is a risk of over-reliance on computer-generated treatment plans, potentially diminishing the clinical judgement and decision-making skills of those responsible for delivering treatment. A digital simulation may predict an ideal outcome, but clinical reality is often more complex and nuanced and requires careful consideration.
This is particularly relevant where tooth movement relies on the creation of space through interventions such as interproximal reduction (IPR). While treatment-planning software may indicate that IPR is required to achieve the desired alignment, clinicians must exercise independent judgement when determining whether IPR is necessary and the extent of enamel reduction that is appropriate. They must also ensure they have the requisite skills to undertake the procedure safely and to the appropriate standard as there have been a growing number of claims relating to substandard IPR treatment and excessive removal of tooth structure.
If treatment fails because clinical issues were overlooked in favour of a computer-generated plan, questions are likely to arise as to the competence and capability of the practitioner. This may expose the clinician not only to civil claims, but also to wider regulatory scrutiny regarding their competence and fitness to practise. The GDC has produced specific guidance relating to clear aligner complaints which highlights the importance of undertaking appropriate pre-treatment assessments, managing patient expectations and obtaining valid consent, including discussions around procedures such as IPR and the limitations of aligner therapy.
Treatment planning services
This issue becomes further complicated where external treatment planning services are involved. Many aligner providers offer treatment planning support whereby digital mapping and models are generated by specialist technicians, software systems or third-party providers who are sometimes located overseas. Whilst these services can enhance efficiency, they also create uncertainty regarding responsibility when problems occur. The treating dentist may consider that responsibility for the treatment plan remains with the external provider, whereas the patient may reasonably assume that the treating clinician was solely responsible for all aspects of the plan.
To reduce the risk of disputes, practitioners offering clear aligner treatment should have clear and documented discussions with patients regarding who is delivering the treatment, who is responsible for treatment planning and who retains overall responsibility for their care. As treatment pathways become increasingly reliant on external providers, digital platforms and third-party treatment-planning services, transparency around these roles is essential to ensure that patients understand who is involved in their treatment and where accountability ultimately lies.
From an insurance perspective, the use of AI or external treatment-planning services should not automatically fall outside a dental indemnity policy. As treating clinicians remain responsible for diagnosis, treatment planning and patient care, allegations arising from reliance on these tools are likely to present within clinical negligence claims.
Practitioners should nevertheless ensure that their insurer is aware of how these services are being used and that the activity falls within the scope of their cover. Clear documentation of the clinician’s decision-making, the responsibilities of any external provider and the contractual arrangements with technology suppliers will also be important. As these technologies develop, policy wordings should provide clear protection where a clinician is exposed because of a software or third-party planning error, while preserving the insurer’s ability to recover from the technology provider where appropriate.
Summary
While clear aligner technology continues to evolve, the fundamental legal principles remain unchanged in respect of the duty of care owed to patients, irrespective of which platform that care is provided by. Dental practitioners will need to continue to exercise independent clinical judgement, obtain informed consent and ensure that patients are suitable candidates for treatment.
Ultimately, if things go wrong, responsibility is likely to rest with the treating clinician, and the key question will be whether they acted in accordance with the standard of care expected of a reasonably competent practitioner. Against this backdrop, policy wordings will need to be carefully reviewed as practitioners will need to make sure that their policies remain fit for purpose in relation to claims arising from AI and external treatment planning services and other emerging technologies within dentistry.
If you have any questions or would like advice on dental negligence matters or support on indemnity and insurance matters, please contact Louise Jackson, Keoghs partner and England and Wales regional lead for healthcare and sport, or Sabrina Mahmood, Keoghs senior associate and dental claims specialist in healthcare and sport.
For robust dental indemnity cover, contact Densura.
This article is sponsored by Densura.
