This month, Richard Jones discusses DIY orthodontics, including the official rules and guidelines surrounding the treatment and the importance of following them.
I am delighted to be writing my first column for Dentistry.co.uk as part of a regular orthodontic column. My co-contributors and I, Dr Zaid Esmail and Dr Tom Witcher, work at Total Orthodontics, part of Bupa Dental Care.
In this edition, I shall focus on the controversial topic of direct-to-consumer aligner treatment. I will explore official guidance and regulatory frameworks for this treatment modality and remote orthodontics in general.
Direct-to-consumer or DIY orthodontics is often marketed as a cheap, fast, and effective way to straighten teeth. All of this sounds appealing. However, it could present a genuine risk to a patient’s health.
Such treatment usually comprises aligners purchased online without visiting a dental practice. Instead, it involves a ‘do-it-yourself’ kit. This allows patients to take impressions at home or visit a shop or pop-up site for a digital scan.
Aligners are then sent through the post. Worryingly, this generally happens without seeing a dentist or orthodontist.
Remote interactions and consultations within dentistry and orthodontics are becoming more widely used. In addition, they can provide significant patient benefits, particularly regarding access and affordability.
New technologies are to be welcomed and encouraged. Of course, this is provided they are employed to provide safe and improved services and outcomes for patients.
There have also been changes in patient expectations and increased demands for these services. The increased demand and uptake of such services by patients and providers has been accelerated by the Covid-19 pandemic. This is because it limited patient access and capacity within practices.
Product development within this sector has also experienced a boost during this time.
However, if such services and technologies are not employed responsibly in a manner consistent with the highest current professional standards, there remains potential for abuse. This abuse may adversely impact patient safety, treatment outcomes and public confidence.
Significant concerns exist within the profession surrounding the provision of direct-to-consumer aligner services.
These concerns include:
- The lack of an appropriate examination and diagnosis
- A lack of fully informed consent discussing all appropriate treatment
- Absence of ongoing supervision of active treatment and retention
- The nature of the relationship between the patient and treating clinician.
In May 2021, as part of its statutory duty to protect the public, the GDC released a statement on “direct-to-consumer” orthodontic treatment. This was in response to the evolution of tele-dentistry technologies. In particular, it responded to the increasing number of organisations offering services remotely, direct to patients using clear aligners.
The key points of the statement include:
- These services fall within the legal definition of dentistry, so they can only be performed by dentists and dental care professionals who are registered with the GDC and who must adhere to the GDC’s Standards for the Dental Team
- Before treatment, all patients require a physical, clinical examination as a basis for a full oral health assessment
- Should a prescribing clinician rely on diagnostic information from another source, then the responsibility for clinical decisions lies wholly with the prescribing clinician
- There is a need for valid consent before and throughout treatment. Patients must have the ability to interact directly with the dental professional responsible for their care. This includes being aware of the clinician’s full name and making direct contact with them.
In June 2021, the CQC released a statement on registration requirements for providers of ‘direct-to-consumer’ orthodontic treatment. This was to clarify the registration requirements for this type of care.
The CQC considers orthodontic treatment provided to patients following an intra-oral scan or when a patient has taken impressions themselves to be a regulated activity.
Where a service is carrying on what the law describes as a regulated activity, that provider must register with CQC. To register with the CQC, providers must assure the regulator that they are able to provide safe and effective care in line with relevant legislation and guidance.
Providers cannot legally carry out regulated activities without registering. Under section 10 of the Health and Social Care Act, it is an offence to provide regulated activities without being registered with CQC.
Code of practice
At the request of the GDC, the British Orthodontic Society (BOS) has produced a comprehensive document, ‘Guidance on Tele-dentistry and Remote interactions in orthodontic care’. This provides a code of practice and a framework of reference that the GDC are likely to apply in any cases involving registrants providing remote care or working with direct-to-consumer companies.
A number of aligner manufacturers and providers have also produced their own codes of practice, which is very welcome.
Dentists, orthodontists and dental care professionals must act within their Scope of Practice and adhere to the GDC’s Standards for the Dental Team. Providers of ‘direct-to-consumer orthodontics’ must offer services which include face-to-face patient contact with a registrant authorised to provide direct services to patients.
This should take place as part of the patient consultation. As a result, this will enable the clinician to carry out the assessments necessary for making clinical judgements. This will ensure the proposed treatment is suitable, to prescribe the most appropriate course of treatment, and to address any underlying oral health problems.
It also allows patients to ask questions, provide valid and informed consent (one of the nine core principles). In addition, patients will be satisfied that the course of treatment proposed is likely to meet their needs and expectations.
Following the GDC Scope of Practice, all diagnostic and prescriptive decisions must be made by the treating orthodontist or dentist with adequate training and skills.
To helping protect patients, the BOS has collaborated with the Oral Health Foundation and launched the Safe Brace campaign, a spin-off of the Safe Smiles campaign. This provides some great resources for patients and warns them about the dangers of DIY orthodontics.
Read the previous Total Orthodontics column: IPR is nothing to fear.
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