Whats going on with Invisalign?

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They have also started an advertising campaign suggesting that fixed appliances are outdated technology.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

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?

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  1. I thought the response of the CEO is indicative of the fact that the companies have gone too far.
    Apparently, he believes that he knows better than the specialists.
    In the land of no evidence the salesman is king!
    OR
    In the land of the gullible, again, the salesman is king!

    • To be a fair judge of the CEO’s stance on the ad, I believe that you should read the whole apology letter that Kevin has linked, and not just the excerpt in the blog. The ad was removed, apology offered for the confusing message and inaccurate visual and Joe Hogan (CEO) stated: “Clearly the post was not well executed and the message didn’t come through as intended. The content did not meet our standards at Align and should not have been used”.

    • The apology in the letter to Dr. Malecki of the AAO concerns the instruments portrayed as part of the modern day orthodontic practice (in fact, these instruments were never part of an orthodontic practice) not an apology for the storefront operation in San Francisco.

      From their advertisement: “We’ll use your digital scan to work with a trained Invisalign provider and build a customized plan that will show your transformation step by step. Once you approve it, we’ll create your unique aligners and ship them to the Invisalign orthodontist or dentist of your choice (we’ll give you a list of great options during your Invisalign Store visit).”

      Concerning the actual storefront operation, I draw on my 35 year experience with a medical managed care organization and see some similarities with popular “health fairs” that are conducted and have been conducted for many years all over the United States where vital signs, weight, height, and in some instances HbA1c and cholesterol testing etc. are performed. These have proven to be very popular and convenient especially for those individuals that do not or rarely see a physician. If any of the results are suspicious, the individual receives a recommendation or referral to see a physician for further testing and possible treatment.

      My inner lawyer tells me that if there any legal proceedings with the Invisalign facility, the argument will be made that a duly licensed practitioner will make the final determination and implement treatment and will be responsible for patient care. The scan performed is essentially a “screening” similar to what is done at “health fairs” for potentially very serious medical conditions. I do not know this but I think that the Invisalign facility probably takes more records in addition to the scan. These records are then digitally transmitted to a licensed orthodontist. In the United States, the digital transmission of complete diagnostic medical records records is usual and customary and has been for many years.

      Analyzing this further, one can get pretty upset that a commercial organization is getting involved in our profession but then thinking about this I have a different perspective. What is the actual result? I sense that many additional adult patients will be receiving orthodontic treatment because of the convenience (open seven days a week) of this screening and that should be good for the profession.

    • Excellent comment ! Have you seen there advertising on CNN prime time TV? Both for Invisalign where they tell the public they are the best for moving teeth, and also for Smile Direct club in another advert offering an ‘economical alternative.

  2. All these concerns are real Kevin. But I’m only a specialist dentist.

    Invisalign markets teeth straightening as if it were actually cosmetics. Maybe that’s what it really is?

    • The concept of aligner as ‘a Cosmetic device’ and the user of as a ‘Consumer’ (In Contrast to the Patient-Doctor relationship) may be difficult to contest legally. Just like fittings worn elsewhere in the body to look/project better, these are devices in the mouth to project the teeth better ? If Orthodontists are doing “Business Of Orthodontics”, (as in the US)corporations are doing it their way!

  3. There is no way to get 20 degree root torque with either Invisalign or traditional fixed appliances. There is also not enough(if any ) that correlates the arbitrary positioning of teeth so that they appear “straight” and muscle function and posture.
    The only system currently that can allow for better range of motion(due to the increase of torque angle) is FASTBRACES Technology.
    Little to no discomfort, fast, safe(research backed) and cheaper !

    • There are issues ,on many levels ,with this post that cause me concern for the future of orthodontics and particularly of orthodontics ,as a profession.First a minor point : why the fixation with “20 degree torque”?I don’t understand and would welcome clarification. Again ,many concerns but the major one being the use of the term “research backed “. In order to validate this statement one needs to quote references ,preferably well done research by credible authors in high impact journals ,ideally.This is what this blog is about .Such references need to be independent and NOT provided in an anecdotal or “research “format by a manufacturer.Suppliers are past masters of encouraging us to “drink the cool aid “. Thank you for discussing this treatment modality.

  4. Hi Kevin –
    We have had a similar model of “Invisalign clinic” in Sydney in the past. Patients attending the clinic had orthodontic records – photographs, radiographs and in those days PVS impressions, then the patient was referred to the closest, highest submitting orthodontist using Invisalign. The centre served the company, or at that time the distributor several purposes; shop-front advertising opportunity, high conversion rate to treatment and also benefited loyal Invisalign customers by “feeding” them “Invisalign ready” patients. In no way was the treatment planned/ conducted by the clinic. Patients were educated / marketed to regarding Invisalign. Records were however taken and patients often were referred for general dental work prior to referral to an orthodontist. Dentists were employed by this clinic. I have no intimate knowledge of the San Francisco clinic. My assumption – I hope that it is correct – is that the model would be similar to the Sydney model in that prospective patients would be informed about benefits of Invisalign, be offered a scan, photos, have radiographs organised and then would be referred to a high submitting Invisalign clinician close to the patient (not sure if they are sending to GP’s, Sydney Invisalign clinic was only referring to orthodontists). I further assume that the “treatment” you may be referring to is the initial software plan that is created on the ITero scanner immediately after the initial patient scan. This 3D dental image may then become the focus of prospective patient discussion and if desired, transferred into ClinCheck software for the treating clinician to diagnose, plan and approve. That’s my guess as I don’t know how they could run a treatment facility without a treating dentist. That begs the question – when does treatment begin, when is a patient no longer a prospective patient but a patient? Does it begin with record taking? I’m not sure and as you suggested, rules likely differ between geographies. Either way, I am sure the legal team at Align Technology are aware of the regulations in CA….
    Second topic – the advertising campaign denigrating fixed appliances. I don’t think that this has made it to AUS, and I hope that the powers at be keep it that way! In the past, Align employees were requested not to disparage not only fixed appliances but other aligner companies, to point out the differences and let the appliance, company and results do the talking. Perhaps the messaging has changed. Even as an avid Invisalign user, I find the ad inaccurate, unattractive and disappointing on so many levels.

  5. I am very uncomfortable about this. Invisalign have become convinced by their own marketing. It cannot be credible to say Invisalign is a better system than fixed appliances however it is an alternative for mild cases. A credible RCT is necessary to see how Invisalign compares with fixed appliances particularly in extraction cases however getting such an RCT off the ground is not easy. Perhaps part of the reason this is being considered is the belief the new patient consultation fee and the focus on making the patient dental fit before treatment is a barrier to care rather than an essential part of care. Clearly there is a belief from Invisalign the growth area is in the mild cases not visiting either dentists or orthodontists. I can see if you were a mathematician there are a lot more of these people however they are not all in need of care. Does the risk vs benefit of treatment equation need further differentiation if aligners make the teeth move rather than fixed? I can see some of the risks of treatment being the same for example the failure to complete the treatment.

  6. You also forgot about the 800 finders fee that the accepting ortho get charged if its a full Invisalign case/ and if it’s a lite case, we only get 500 for our chair time

  7. I suppose a few ideas come to mind – Invisalign have more legal opinion at their disposal than most orthodontists can imagine. And they have the resources behind them to keep those lawyers working long after a group of dentists can.

    Their advert might have upset a few of us, but my guess is if it had shown a photo of some brackets made by one of the larger conglomerates with the same negative caption there would be
    1 ructions
    2 a few smiles at the Learjet factory

    Realistically, these guys are unlikely to be knowingly/demonstrably operating outside the law in a given jurisdiction for long. And if tweaking their model is required to take the heat off them, it is no problem for them to get a dentist in to their “store” to comply with what ever needs to be complied with, even if he never ends up seeing the “patient” again.

    There was one address to the AAO earlier this year where the speaker explained that the market for orthodontics is huge, but orthodontists just need to get used to the idea of providing it for a third of the price they normally charge for it. I don’t imagine that went down well with many of them.

  8. In my country the aligners are so expensive that the only ones that earn money are the people who teach the procedure. No one can say that kind of treatment is better than the fixed appliances.

  9. How rare is true critical thinking in Dental online communities and how common the recruitment to teams. Thank you Kevin for championing the former.

    Is it possible there is a common thread between Myofuntional appliances, this approach from Invisalign and the role of the key opinion Leader. In various ways all are utilising a successful approach to the diffusion of innovation. The only thing lacking is the evidence of effect to justify that diffusion.

    Is it possible that until published evidence finds a way to insert itself into the mind lines of practitioners and the public and that innovation diffusion is driven not by a funding component of a business plan but by public need we will continue along this road?

  10. Unfortunately! That is the name of the game now ( go directly to the consumer’s money) not a health care anymore!! It will only get worse from that aspect! But also positive that it will speed up the public awareness and knowledge about the meaning of a real health care; which is supposed to be our responsibility in the first place!

  11. I feel there is a need for development of a ‘business marketing regulatory body’ within the framework of GDC or at least British Orthodontic Society, considering the changing trends in business development in the modern times and its encroachment and undeniable influences on the healthcare delivery system.