An occasionally irregular blog about orthodontics

Do it yourself orthodontics revisited: Invisalign and SmileDirectClub and others…

By on August 30, 2016 in Personal opinion, Recent posts with 12 Comments
Do it yourself orthodontics revisited: Invisalign and SmileDirectClub and others…

Do it yourself orthodontics: You do not even need to see a dentist!

This post is a follow-up edit to a previous post on do it yourself orthodontics.  I have revisited this subject, as I think that it has become more relevant since Invisalign announced that they had agreed to supply aligners to SmileDirectClub.  This is one of the several companies that provide “do it your self orthodontics” and provider aligner treatment direct to the public without them seeing a dentist. In this blog I will discuss this latest development.

I will start with two companies who have been advertising in the UK. These are Straight Teeth Direct and Your Smile Direct. They both adopt similar approaches on their websites. They provide treatment with clear aligners  at a lower cost than that provided by dentists or orthodontists. This type of provision has been carried out in the USA for some time and was the subject of an article in the New York Times.

183571The process of getting this treatment from these companies is  similar. For example, with Straight Teeth Direct the “patient” completes a short questionnaire and then uploads photographs of their teeth to the website. The company then lets them know if they are suitable for their treatment.   They then send a “Smile Box” to them which contains material so that they can take their own impressions. Alternatively, a dental nurse can visit a group of friends and hold a “Group Smile” and they will take a 3D scan of the teeth.

The scans/models of the teeth will then be examined by a registered dentist and a treatment planned. They will then send back a series of aligners. If interproximal reduction is needed as part of the treatment they will put the patient in touch with a dentist who will carry this out. The approximate cost of treatment is between £899 and £1650 depending on the severity of the malocclusion.

Your Smile Direct is similar but their questionnaire asks you to tick a box that represents the amount of crowding or spacing in your teeth. They do not offer a “Group Smile” or offer IPR.  The cost of their treatment is £1,199.

I could not find much background information on Your Smile Direct.  But  Straight Teeth Direct appears to be run by a registered dentist.

Details of these two companies can be found here:

Straight Teeth Direct

Your Smile Direct

Following the launch of Straight Teeth Direct, the dentist who ran the company was reported to the General Dental Council (the UK Dental Regulator with a role of protecting the public).  They organised an investigative hearing and they directed he must not  undertake any orthodontic treatment without having conducted an in person full clinical examination for a period of 12 months while they investigated this case further.

This was an interesting development and it was made on the grounds that patients would not be seen by a dentist before they had orthodontic treatment. As a result of this case Straight Teeth Direct do not offer this service in the UK.

The British Orthodontic Society also released a good press release about this issue and they pointed out that

“A full clinical examination by a trained clinician is necessary to decide if orthodontic  treatment is in the best interests of an individual

the public that orthodontic treatment should always be provided”.

It, therefore, appears that action to protect the public against the provision of orthodontic treatment without seeing a dentist, in the UK, has been taken. Nevertheless, there is nothing preventing dentists/organisations from other countries providing this treatment to patients anywhere in the World. For example, Your Smile Direct is a company based in Dublin, Ireland and is becoming more active in the UK/Europe.

The Invisalign and SmileDirectClub partnership

Until recently, this method of delivery of orthodontic treatment appeared to be done on a small scale. However, the volume of this may increase as Invisalign has now agreed to supply non-invisalign clear aligners to SmileDirectClub in North America. Here is a quote from their press release..

“Specifically, Align will provide a case setup through SmileDirectClub’s SMILECHECK viewer portal, and, upon review and approval by a participating licensed orthodontist or general dentist in SmileDirectClub’s network, Align will manufacture clear aligners and ship them directly to SmileDirectClub”.

I have had a good look at the SmileDirectClub website and they operate by getting prospective patients to take photos of their teeth or get a scan done at one of their “Smile shops”.  They then assess suitability for treatment with trained dentist giving an opinion.  If they feel that the patient is suitable for treatment  they send them an impression kit and they take their own impressions. A short time later they send the aligners to the patient. The treatment is then provided by the patient changing their own aligners.  Importantly, the treatment is only monitored by the patient sending photographs back to SmileDirectClub Direct, there is no direct clinical input.

As a result, of this entry into the market of one of the major orthodontic companies, I am sure that this treatment will become more popular.

What do I think?

I must admit that I am concerned. This is because I am not clear on the safeguards that are in place for those patients who may seek this form of treatment. Importantly, there is no direct contact and clinical examination of the patient’s mouth and assessment of their dental health by a dentist. This is important because I cannot see how anyone can assess the health of a patient’s mouth by viewing photographs that are taken on a phone.

My other concern is with the clarity of the person who is responsible for providing the care. When care is provided by a dentist or orthodontist there is no doubt that if there is a problem with the care, the treating dentist is responsible to their patient, the regulators and the legal system. As this new system does not involve direct treatment by a dentist, it is not clear who is clinically responsible for the treatment. I assume that this will be the registered dentists who are planning the treatment from the study casts and photographs. They may, therefore, be in a position of high risk. Furthermore, it is unclear who the patient can take action against if they wish to take legal action.  As a result, this type of care may be provided with limited protection of the public and this is an important ethical issue that may vary from country to country.

Furthermore, I cannot see how a patient can give informed consent, if the risks, benefits and options for care are not discussed by a dental health care professional.

The other important point with  the taking of 3D scans on patients who have not seen a dentist may be a “grey area” in terms of the clinical tasks that are within the scope of practice of a people who are not dentists. Again, the legality of this may differ from country to country.

Some people may consider that I am being protectionist.  However, I can assure you that I am not. I  welcome initiatives that increase access to dental care. However, if these initiatives involve reducing the direct input of adequately trained health care practitioners, then the price to pay for increased access may be greater risk and limited protection for the public.

It is also interesting that this does not appear to have caused any concern with the dental representative bodies. The only group that has responded to these developments is the British Orthodontic Society. Is there anybody else out there?

These are early days for this type of provision of care and this may be something that does not become popular with the public. We are entering the unknown..

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There Are 12 Comments

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  1. Klaus Barretto Lopes says:

    Dear Kevin,
    As a member of the Brazilian Orthodontic Society I am sure that this practice is not permitted in Brazil yet. Just orthodontists can treat patients with clear aligners. General dentists are not permitted either.
    However, as you, I am very concerned about it. For the other hand, I am happy that the British Orthodontic Society took measures against this practice. This can be a beginning for other important societies around the world take part.
    I am very disapointed with Invisalign about its position.
    Best wishes,
    Klaus

  2. Bob Stoner says:

    With the level of competence of some clinicians, I’m not sure this is any worse. That said, the ability of aligners to achieve a good functional occlusion is poor in most cases. I’m not sure why so many are promoting this treatment. In my opinion after 33 years of practice here are few cases that aligners are appropriate.

    • Vicki Vlaskalic says:

      Point taken, and to develop that thought, it is some clinicians who may fail to achieve a “good functional occlusion”, not the aligners.

    • Vicki Vlaskalic says:

      Point taken – and following on from that, it is not “aligners” that achieve a “good functional occlusion”, but the clinicians.

  3. Nicky Stanford says:

    Well…the CEO of yoursmiledirect is recruiting on twitter…

    https://mobile.twitter.com/Grahambyrne

  4. Andrew Adey says:

    Here in the UK general practitioners are allowed to use clear aligners – I am one of them. I use Invisalign and have done for about 12 years. I am VERY saddened to see a huge company like Align Tech go down this route, and wait to see what will happen. I don`t think it will end well – unless regulators take their collective feet off the brakes protecting the public and the profession.

  5. Gisli E Arnason says:

    What about relapse? They don´t seem to be concerned about relapse! Treating only crowns (tipping teeth) will only set them up for a relapse. Lot of the cases displayed are cases with diastema that will most certainly relapse without any retention.

  6. John McDonald says:

    Kevin,
    Invisalign held a conference call in the U.S. about 2 weeks ago to address orthodontists and their concerns about their relationship with SmileCareClub (SCC). Here are a couple of things that were covered that might be of interest:
    – SCC was started and is run by the same people who do 1-800 contacts and some other direct to consumer health care.
    – Invisalign initially sued SCC but after the invisalign CEO meet with them, They were impressed enough that they bought 17% of the company and now have a seat on the board.
    – Invisalign CEO reports that SCC will not be doing IPR on their cases. (The web site tells a different story)
    – SCC has apparently vetted their process with most if not all states Attorney General’s to insure compliance with State Board requirements.
    – No invisalign branding will be used on the aligners provided to SCC. The material being used is older generation plastic that is performs at a lower level than their new material.
    I hope this helps the discussion moving forward.

  7. Joe Lohner says:

    Guess we’ll be fixing these cases eventually? Who will be responsible for retention ? ?

  8. salesse says:

    There was reaction in the US.
    Dental council in several state stated that any dentist participating in the treatment (taking impression, picture or stripping) would be liable for the full treatment outcome.

    • Loke says:

      Wow! This is taking DIY orthodontics to a different level…… sounds a bit ‘fishy’ if they are supplying the aligners & technology but not labelling as from their company… Thank You Dr.O’Brien for bringing this to our attention

  9. Vicki Vlaskalic says:

    Protectionist – that you are Kevin!….of the public. Usually after reading blogs and such mentioning Invisalign and Align Technology, I feel obligated to spend time defending them against many misconceptions and much self-serving thinking. This time Kevin, I have to agree with you. I was gutted hearing the news regarding Align Technology’s association with such a scheme. Up until that point, Align worked hard to have our profession join ( help make) their journey. We may have had issues with the novel marketing practise of Align ,early claims of users requiring no orthodontic experience and the non-discriminatory recruitment of the broad GP market into the practise of orthodontics; however, I always felt that the company at large and the last 2 CEO’s were genuinely respectful of our profession and specialty. Align Tech actively looked for ways to work with us and invested in the health and well-being of our patients by striving to improve the mechanical ability and scope of the system. They rigorously support dental and orthodontic professional organizations, university and individual practice clinical research. For the almost 20 -year journey, Align have worked hard to get our profession “on board”, to gain credibility as a leading orthodontic appliance manufacturer, aiming to put the “science in every smile”. The recent business strategy in question appears to make a mockery of this hard-won relationship.
    It baffles me to comprehend how a company that relies on dental professionals for its survival can make such an ill-informed and unpopular move. I was amazed to see the prices Kevin – it’s not even that cheap, so the “defence” that now more, otherwise financially strapped public have access to “orthodontic treatment” is lame! Align appears to have not only risked alienating themselves further from the specialty of orthodontics but from the entire dental profession.
    My faith lies in a few places, first that the public at large is not careless with their bodies, second that regulatory organizations other than BOS begin to see how these schemes place the public at significant risk (once a few cases reach litigation… for failure to deliver an improvement or even worse, damage dental tissues -think of the recession and dehiscence risks, or for negligence due to missed potentially life-threatening oral lesions). And third, I hope that we as a cohesive dental fraternity communicate our disapproval of Align’s promotion of by-passing clinicians. Align does have a good history of listening to its top users who speak with their “accept” buttons.
    Reply

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