This post is about Invisalign’s recent opening of an Invisalign store and their recent advertising campaign.
The introduction of aligners by Invisalign has been one of the most important developments in orthodontics. As a result, Invisalign are a major orthodontic company that works with orthodontists and dentists to deliver aligner orthodontics. Recently, Invisalign bought a large shareholding in Smile Direct Club (SDC). Smile Direct Club provides aligners directly to patients without them seeing a dentist. I have posted about this previously.
It now appears that Invisalign are exploring a similar model with the opening of an Invisalign store in California. The model of delivery of care is this;
- A person who is interested in orthodontic treatment attends the store.
- The staff, who may not be dentally qualified, discuss treatment and scan their teeth.
- The technician then builds a ClinCheck and discusses this with the patient.
- The patient then selects a local dentist/orthodontist to monitor the treatment.
- Invisalign sends the records to the monitoring dentist/orthodontist. They then decide if they want to accept the patient and make any changes to the plan.
- The patient then attends the dentist/orthodontist to have their aligners fitted and treatment monitored.
They have also started an advertising campaign suggesting that fixed appliances are outdated technology. Here is a screen shot.
Interestingly, I have not seen a high quality trial that show that treatment with Invisalign is as effective as fixed appliance treatment. Their use of extraction forceps is also rather strange. Does this suggest extraction treatment or an attempt to reinforce the “tightening, cranking and twisting” statement?
Since the publication of this advertisement the AAO and the CAO have written to Invisalign and they have responded with an apology letter. However, in the letter the Invisalign CEO wrote
“We know that doctors and consumers have choices regarding treatment, and while we believe that aligners are the best and most modern option for straightening teeth, we want to get that message across in a way that is positive for our brand”.
It appears that Invisalign is promoting their product to patients by suggesting that it is more advanced than fixed appliances.
Is there a problem here?
I will only put forward my interpretation of the store development with respect to the UK dental regulations. I think that there are several issues. These are concerned with whether a dentist examines the patient in the Invisalign store.
I have emailed Invisalign to clarify this issue, and they have not replied. However, enquiries to the store suggest that a dentist does not work there.
Assessment of dental health
The first stage of any dental treatment must be an assessment of the patient’s oral health. This can only be done by an appropriately trained and registered dental professional working within their scope of practice. In the Invisalign store model I cannot see how this vital assessment is done; because the patients may not be seen by a dentist. This is a fundamental patient care issue.
Consent must be obtained before treatment starts. The only person who can obtain fully informed consent for orthodontic treatment is a dentist. Therefore, the patient cannot consent to treatment in the store. Importantly, if the aligners are made before the patient attends the monitoring orthodontist/dentist, consent can only be retrospective. This carries considerable risk. However, if the monitoring dentist physically examines the patient and orders the aligners after their examination, fully informed consent can be obtained.
The illegal practice of dentistry
I am not 100% clear on this issue. Importantly, we need to consider that because the scans are used to make the aligners, scanning would be classified as the practice of dentistry. In the UK only Dentists and Dental Care Professionals can legally practice dentistry; as long as they work within a defined scope of practice. As a result, if this model of treatment delivery was done in the UK, the store technician would be practicing illegally and they may be prosecuted.
Who takes responsibility for the treatment?
This is clear. It is the dentist who is monitoring the treatment. The staff in the store who initially planned the treatment are not responsible. Consequently, if there are severe problems with the treatment the monitoring dentist would be subject to a fitness to practice hearing.
I am not sure about USA dental regulation. I think that this varies from State to State?
What do I think?
From my knowledge and interpretation of UK dental regulation, I am not sure whether this type of treatment can be provided in the UK. For example, a UK based dentist attempted providing aligner treatment without patients seeing a dentist sometime ago. The British Orthodontic Society reported him to the General Dental Council, and he was prevented from this practice pending a full disciplinary hearing.
The GDC’s Director of Fitness to Practise, Jonathan Green said:
“Face to face consultations are an essential aspect of delivery of safe patient care”.
“Where a business model potentially compromises patient care or is on the face of it incompatible with our Standards for the Dental Team, we will act.”
It would be interesting to hear the views of the Specialist Societies or regulators on these developments. It is early days and it is very quiet (although the AAO and CAO have written letters to Align about the advertisement but not the store). AAO are you out there or just comfortably numb?