April 22, 2024

Has Invisalign advertising “crossed the line”?

One goal of my blog is to challenge the claims and assertions of companies and their paid clinical salespeople. I hope that by bringing attention to unethical advertising practices, I can influence some companies to change their ways.

Though I strive to be successful in this aim, at times, I feel as though I am losing the battle.

I am concerned about the latest campaign by Invisalign and their introduction of the Invisalign Palatal Expander (IPE). This is part of their attempts to develop appliances used in Phase I interceptive treatment of children. 

The IPE is a single piece of plastic that fits on the palatal surface of the upper arch along with some buccal tooth coverage. The patient changes the appliance daily, and the sequential appliances gradually increase the width of the arch. However, due to their design, they must only have limited contact with the teeth. This means that the IPE is likely to have a similar mode of action to a simple removable split plate with a mid-line screw. As a result, they are likely to achieve mostly tipping movements, and it is unlikely that they would achieve skeletal expansion as we do with RME and its variants. This is something that anyone with basic orthodontic knowledge would realize.

What do Invisalign suggest?

The latest advertisements state the following:

  • The expander is less painful than traditional palatal expanders
  • Clinically proven to be safe and effective
  • A revolutionary new design with no metal screw
  • One hundred per cent of surveyed Invisalign-trained orthodontists agree that the IPE reduces anxiety in patients compared to traditional expanders.

They have mentioned some references in the fine print on their website. However, these references only state that “the data is available with Align Technology”. It is noteworthy that the claim about reducing anxiety is based on a survey of only 10 orthodontists who have treated at least one patient with IPE. This cannot be considered as a scientifically sound evaluation.

The claim that I was most concerned about was.

“The IPE system is the only FDA-cleared removable palatal expander that’s just as effective as traditional expanders”.  

Let’s break down that statement. The FDA grants clearance to appliances that are similar to other appliances currently in use. Therefore, since this appliance is similar to removable expansion plates, there shouldn’t be any clearance issues. Additionally, there is currently no data available on its effectiveness.

In another advertisement, Invisalign compares IPE to RME and suggests that RME is medieval.  Here is a screenshot. You will see that they state

“traditional palatal expanders work by inserting a tiny key and cranking the appliance wider every day. The process is difficult and stressful for kids and adults”.

Invisalign advertising

This advertising style also concerns me because it suggests that orthodontists who use RME, the standard care, are outdated. This is not good.

What do the KOLs say?

Shortly after the start of the advertising, the KOLs were pretty quiet. However, recently, they have started to appear on orthodontic social media. Most of these posts show poorly documented expansion case reports. These do not persuade me that IPE is effective or superior to other methods, such as RME.

Have Invisalign crossed the line?

There are two issues regarding Invisalign’s advertising. Firstly, they make claims without providing supporting data. This may be wrong because the evidence is not subjected to external scrutiny.

While they emphasize FDA clearance, it is important to note that this is only because the appliance is similar to other expanders. Furthermore, despite what their advertising states, there is no published evidence to suggest that this appliance is any better or different than a removable expander. Additionally, it is worth noting that patient cooperation is crucial for Invisalign Palatal Expander, which is less of an issue with fixed expanders.

Secondly, it is rather strange to claim that fixed appliance screw expansion is a “medieval” method, implying that conventional orthodontic treatment is not as advanced as the new Invisalign treatment. This claim is unfair and only creates a divide between specialists.

After writing the post, I learned that Invisalign withdrew its “medieval advertising” after pressure from the Canadian Association of Orthodontists. Invisalign admitted their mistake, which is the appropriate course of action for an incorrect claim.

Final comments

Invisalign have, yet again, made claims about their appliances that are not supported by research. You may remember the promotion of the Mandibular Advancement Appliance. It is odd that such a successful company takes this step, as it is unnecessary.

Unfortunately, the specialist associations have not yet asked them to withdraw these advertisements. It is high time for the major specialist societies to step up and speak out. Ethical orthodontists cannot do this by themselves.

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Have your say!

  1. Well said, Kevin! In my lectures and presentations, I point out that these types of appliances (that mimic Dr Earl Bergersen’s original orthodontic tooth positioner patent) have no expansive mechanism per se, and cannot legitimately be promoted under the guise of “palatal expansion”.

  2. “In another advertisement, Invisalign compares IPE to RME and suggests that RME is medieval. Here is a screenshot. You will see that they state “traditional palatal expanders work by inserting a tiny key and cranking the appliance wider every day. The process is difficult and stressful for kids and adults””
    My comment is about this sentence above and my question is: Why to use TINY KEY for normal RPE activation? Why, if there are so many nice and safe long handle keys on the market. You can choose with a flower, also with a teddy bear and colorful ones. At least in Europe

  3. These are apples and oranges. Align adds are not for educated professionals but for a public. It’s 5th grader language.
    There is absolutely NO comparison between fixed metal RPE (hyrax of haas style) and IPE. IPE, however could be rightfully compared to Schwartz removable expander or, even, fully self-adjusted, banded NPE or Leaf expander and Arnold’s E-Arch. But all those are SPE appliances, not RPE. However, there are several studies indicating that net long term expansion of both Slow and Rapid expansions are very much similar: 50:50 skeletal and dental.
    Compliance is very much needed in all except NPE and Leaf and Arnold’s E-Arch.

  4. I will be hearing more from patients very soon and trust me it will portray fixed RME as yesterday. Perception is reality and this type of presentation appeals to the new normal. I will be required to offer it in my community or be perceived as behind the times.


  5. Thanks for your blog, I find it very useful.
    As a general dentist who practices orthodontics, it is nice to have a reliable, unbiased information source.
    I like the way you summarize things to pass important information without having to spend too much time reading.
    the whole paper.
    I hope you keep on for many more years, I really appreciate your input on things!

  6. Funny. I am looking at this blog WHILE I am in the IPE lecture and I was thinking the SAME THING!!
    Also all their studies were age 7-9
    Most were “underdone” in terms of expansion (in my clinical opinion)
    no ability to help with hypo=divergent/low angle or habit cases

  7. Thank you. I saw the advert on my social media feed and was very concerned that they described RME as ‘difficult and stressful’ for parents and children. Getting a child to wear a removable appliance could be conceived as ‘difficult and stressful’ by some.

    If someone wanted to try the aligner options then informed consent is the way to go here, ‘this appliance I’ve used x times with these results, this other appliance is new with no proven results’, but I feel like the hard sell from Invisalign, particularly direct to patients, is going to be hard to overcome, not to mention the many invisalign users who are not trained in orthodontics in general and therefore familiar with more traditional appliances.

  8. Thank you Prof.OBrien for your timely, honest and authoritative consideration. The so-called Invisalign IPE expander does not reflect the mechanical characteristics and consequently the clinical performances of the classic fixed-type skeletal expander. As you have already underlined, the lack of scientific evidence as well as the poverty of clinical results corroborate your considerations and our impressions. Continue with the fixed to obtain real effective and real expansions of the upper jaw. Thank you

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