Wednesday, May 29, 2024

DentalMonitoring Receives De Novo Approval by FDA for Orthodontic Remote Monitoring

 



AI continues to make incredible progress in the profession of dentistry.  We have seen AI systems that help with radiographic interpretation, scheduling, and even in the speciality area of orthodontic treatment.  I consider myself lucky to have been involved with AI in the profession since its infancy.  I've been able to work with several AI companies over the years and I am continually amazed at the progress this tech has seen in the dental market.

Now we are witnessing even more amazing developments in AI, with DentalMonitoring announcing a new De Novo approval from the FDA.

On May 20th, 2024, DentalMonitoring made waves in the dental industry by receiving De Novo approval from the U.S. Food and Drug Administration (FDA) for an innovative solution. This marks a significant milestone for both DentalMonitoring and the future of orthodontics, paving the way for a more tech-driven and accessible approach to dental care.

What is DentalMonitoring?

DentalMonitoring is a software-as-a-medical-device (SaMD) that utilizes artificial intelligence (AI) and machine learning to remotely monitor orthodontic treatment progress. Here's how it works:

Patients take regular scans of their teeth using high-resolution images.  This is accomplished through an app installed on their mobile phone and a special device that attaches to the phone.  The device helps hold the patient's lips retracted while allowing the phone's camera to capture images of the teeth.

The scans are uploaded securely to the DentalMonitoring platform.

DentalMonitoring's AI technology then analyzes the scans, generating reports and visualizations that track tooth movement and treatment progress.

Doctors can then remotely monitor their patients' progress, identify potential issues early on, and adjust treatment plans as needed.

Benefits of DentalMonitoring's De Novo Approval

This FDA approval signifies the validity and safety of DentalMonitoring's technology. Here are some of the potential benefits for both patients and doctors:

Improved Patient Experience: Patients can benefit from fewer in-office visits, potentially leading to more convenient and flexible treatment schedules.

Enhanced Treatment Monitoring: AI-powered analysis can offer doctors a more comprehensive view of treatment progress, allowing for earlier intervention if necessary.

Increased Patient Engagement: Regular monitoring reports and visualizations can empower patients to feel more involved in their orthodontic journey.

Potential Decrease in Problems: Doctors can be made aware of discrepancies in expected treatment as well as other issues such as gingival inflammation and/or decalcification of enamel during treatment.  

A New Era for Orthodontic Treatment

DentalMonitoring's De Novo approval marks a significant step towards a more tech-centric future of orthodontics. While traditional in-office consultations remain crucial, AI-powered remote monitoring tools offer valuable potential for enhancing patient care, treatment efficiency, and overall patient experience.

It's important to note: DentalMonitoring is a tool that complements, not replaces, the expertise of a qualified orthodontic provider.

Looking Ahead

The future of orthodontics is likely to see further integration of AI and remote monitoring technologies. DentalMonitoring's FDA approval is a strong indicator of this shift, and it will be interesting to see how this innovation shapes the way orthodontic care is delivered in the years to come.  Expect this area of AI in dentistry to continue to advance rapidly.


Tuesday, May 28, 2024

Artificial Intelligence Webinar Questions & Answers

 


On Monday May 20th, I was honored to present a webinar on the Viva Learning platform.  (Disclosure: The event was underwritten by Philips Sonicare.). The Viva Learning platform allowed for one hour of content and unfortunately I didn't have any time left to do a Q&A with the attendees.

However, before signing off of the event, I copied all of the questions submitted via the Zoom chat feature and saved them.  I told the attendees that I would answer the questions on the blog, so here they are.  If you didn't happen to submit a question, feel free to submit them below in the "Comments" section and I'll do my best to answer them at a future date.

  • Question:  Can "AI data" be used in court?  Is the law keeping up with technology and are insurance companies using AI to adjudicate claims?
    • Answer:  I do some expert witness work in the dental malpractice field.  I haven't come across AI being used in a court of law yet, but I certainly think it will be.   One of the reasons I feel I haven't seen it yet is because, in my experience, it seems to take a really long time to get a case to court.  Cases can take years before an actual trial occurs.  Since AI has really only gone 'mainstream' since 2022-2023, nothing I've worked on has included AI.  That being said, I certainly think in the future AI *will* be seen in court cases.
    • Answer:  Yes, third party payers are beginning to use AI to adjudicate claims.  It doesn't appear to be widespread, but it is already happening.  My concern in this area is currently focused on who is creating the AI network and providing the data.  If a third party payer is using *the same data* that doctors are using, I don't currently see a problem with that.  However, I CAN envision a database being created and used that is trained to deny.  That would be a worst case scenario.  My feelings currently are that third party payers need to justify their systems through an unbiased third party audit.  I'm not aware of that happening yet.

  • Question:  What about DEXIS for CBCT?  I think it is called "DTX"
    • Answer: Yes, DEXIS has a nice product.  It is called "DTX Studio" and it has some really great features.  I have 'tinkered' with DTX Studio as an evaluation and I thought it was a good product.  If you are looking for an AI solution for your practice, I think it should be on your list to take a look at.

  • Question:  Out of curiosity, is DiagnoCAT applying for FDA "clearance" or "approval"?
    • Answer:  I don't have a lot of information on that one.  I have looked at the product and worked with some of their test cases.  They allowed me to have access to a limited number of cases so that I could see what they provide and how to use the product.  It's important for me to state here what I am about to say is SPECULATION.  I *think* they are working on FDA 510(K) Clearance, but I cannot state that as fact.  Probably the best thing to do is to reach out to the company directly, if you are interested is where they are in the process.

  • Question:  Does Pearl distinguish between caries and cervical burnout?
    • Answer:  All the systems being used for radiographic interpretation are looking at the images for 'loss of density' but they are also smart and know *where* to look.  The systems *can* make mistakes in areas such as cervical burnout, which is why I always like to emphasize that these systems DO NOT diagnose.  When performing a clinical exam visually, doctors can evaluate a situation using their own diagnostic data that they gain through the exam process.  We use Pearl in our office and I feel it does a really good job of NOT indicating cervical burnout as caries, but the doctor has the final determination of that fact.

  • Question:  Because systems can detect existing RCT, implants, crowns, etc. Can they connect to the office system (i.e. Dentrix, Open Dental, etc.) to chart what is existing for a patient?
    • Answer:  I don't know of a system that can do that currently, but I know companies are working on that.  The biggest road block right now, is the fact that having this feature will require PMS (Practice Management Software) companies to give the AI companies access to their systems.  Most PMS companies are very protective of their systems for a number or reason, chief among them is security.  I see this as a tremendous benefit, but the legal aspects of allowing this access will probably keep this as a 'want' for a lot offices for at least the near future.

  • Question:  How do you implement Pearl or Overjet into the practice?
    • Answer:  Implementation is pretty simple.  We happen to use Eaglesoft and are still on a Client/Sever setup.  When we started, we allowed Pearl remote access to our server which allowed them to install a piece of software on the server.  Once that was done, Pearl uploaded our images into their system.  Now all we need to do is to start Chrome on the workstations and open a tab to log into Pearl.  The radiographs are quickly uploaded (pretty much as they are taken).  When they are uploaded, the patient is then 'clicked on' via the Chrome tab and the images pop up on the screen.  You can then select or deselect the things you would like to see or hide (caries, calculus, periapical radiolucencies, etc.)  We have a tab open to Pearl on every clinical workstation and doctor workstation every day.  I should also add that all of the data is transferred in a HIPAA compliant way.

  • Question:  Does Pearl do any detection in pediatrics?  And other than Pearl and OverJet, are there other AI diagnostics you use or have heard of?
    • Answer:  The first thing I'd like to state here is that FDA Clearances happen frequently in the AI space so it's probably best to check with the company or check the FDA website with specific questions.  My *current understanding* is that Pearl can be used on ages 12 and above while OverJet can be used in ages 4 and above.   I want to emphasize that I am providing this answer based on my current knowledge.  This info may change as I am typing this!  
    • As far as the companies currently providing AI radiographic analysis I'm aware of the following companies: Peal, OverJet, Denti.ai, DentaXr.ai, VideaHealth, DTX Studio, Apteryx XV Web (which uses Pearl), adravision, DentrixDetect, and DiagnoCAT.  This list is probably not inclusive as these are the ones that I thought of as I typed this.  The area of dental AI for radiographic interpreation is a constantly growing and changing industry.

  • Question:  Can you talk about cost?
    • Answer:  While I don't normally like discussing financials, I can give an overview here.  Just so everyone understands, my personal feeling is that if you treat people to the best of your ability and use the best tools you can, a doctor will make a comfortable income.  However, I realize that doctors constantly 'walk the tightrope' between expenses and production.  I often say that you can be the best doctor on the planet, but if you can't stay in business, your skills won't help many people.  So with that in mind, currently the costs associated with AI seem to be under $500  per month the last time I checked.  If you factor in that a 2-surface posterior composite restoration averages around $250, the math is pretty clear that it doesn't take long before the office can see ROI on the investment.

  • Question:  How often is the AI software updated?
    • Answer:  In the 'big picture' every time a user makes a correction to the info they are provided the system learns from that.  So, at least in theory, the systems are being updated constantly.  For major changes, in my experience those are pushed out fairly regularly, maybe once a quarter or so.  The nice thing about these systems being Cloud Based is that when updates happen, the user doesn't have to do or install anything.  If an update has happened over night, the next time you open the tab in your browser, those changes are there for you.

  • Question:  Any HIPAA concerns with uploading patient radiographs to AI?
    • Answer:  I feel that the concerns with the connections between an office and the AI company are no greater than for any other data an office is using when it comes to The Cloud... that includes credit card processing and electronic claims processing, just to name a couple more.  Now don't get me wrong... security should *ALWAYS* be a concern when dealing with patient data and I'm glad you asked that question, because it shows you are concerned about that aspect of things.  There are a lot of people in this industry that have made it their life's work to keep data secure and I trust them to do so.








Thursday, May 23, 2024

ADA Puts Out Statement Warning the Public about 'Veneer Techs'

 



Recently there have been several news stories about unlicensed dentists opening offices and actually treating the public.  That includes a woman who was recently arrested in Cook County Illinois who had been arrested for the same unlicensed dentistry scam in Las Vegas shortly before making bail and heading to the Chicago area.

Many of these "Veneer Techs" market themselves on social media (the accused mentioned earlier had a big presence on TikTok) showing photos of supposed 'happy patients' and showing off treatment they reportedly did.  Of course they offer they can do the same for others... and at much lower price than they could get elsewhere.

This is one of the problems with social media.  If you read it or see it, for some reason, it seems 'more true' than if you simply heard about it.  I am no different.  If I read something that looks professional, I have tendency to think "it has to be true".  Fortunately for me, that feeling lasts a second or tow and then my natural skepticism kicks in and I do some research.  Unfortunately, often good people believe these things to be true and unfortunately act on what they've read or viewed. 

While you dentists reading this know what I'm about to say is true, I'm saying the following to those readers who may not have a great deal of dental knowledge and understanding.  I want to state for the record... Dentistry is not nearly as easy to deliver as we make it appear.  The trained and licensed dentist has under gone years of extensive and expensive training.  Many younger dentists are graduating with hundreds of thousands of dollars in debt due to student loans.  Yet they go into the profession and work hard because they are called to help their fellow human beings.  

It's not about the income it's about the higher calling.

So I'm proud of the ADA for taking a stand and bringing this to the attention of the public.  The ADA addressed this recently in the ADA News, but they also have created a page to inform the public about this scary issue.

Here is the ADA Statement which appears on the ADA website:


Statement on Recent Reports of "Veneer Technicians"

CHICAGO, May 14, 2024 – The American Dental Association (ADA) is aware of recent reports of “veneer technicians” offering services to the public. The ADA urges the public to be cautious of these services that eliminate the role of the dentist in diagnosing the patient’s oral health needs, developing a treatment plan to best meet those needs, and safely managing treatment throughout the course of care.

Unsupervised dental treatment from unlicensed individuals has the potential to cause damaging complications for patients, and any dental procedure that may alter the physical structure of an individual’s teeth, gums or jaws, without the supervision of a dentist, has the potential to cause irreversible harm.

Risks that may be associated with services from unlicensed individuals include potential infection from adhesives and curing devices that are not properly sterilized or from placing veneers over unhealthy teeth or untreated cavities; nerve damage from improperly trimming or filing the teeth; and potential choking hazard during placement.

Dentistry is a regulated healthcare profession that requires formal education and licensure. Every state has regulations that require dentists and hygienists to be licensed in order to provide patient care. The level of oversight for dental assistants varies by state and, while dental assistants may or may not be licensed or registered by the state, they are required to perform their duties under the supervision of a licensed dentist. State dental practice acts define the scope of practice for dentists, hygienists, and licensed or registered dental assistants. However, dental laboratory technicians and businesses are generally not licensed.

The ADA is committed to quality care and encourages the public to seek care from licensed dentists to ensure proper diagnosis, treatment, and patient safety for all of their oral health care needs.

For more information about oral health, visit MouthHealthy.org, the ADA’s public education website.


About the American Dental Association
The not-for-profit ADA is the nation's largest dental association, representing 159,000 dentist members. The premier source of oral health information, the ADA has advocated for the public's health and promoted the art and science of dentistry since 1859. The ADA's state-of-the-art research facilities develop and test dental products and materials that have advanced the practice of dentistry and made the patient experience more positive. The ADA Seal of Acceptance long has been a valuable and respected guide to consumer dental care products. The Journal of the American Dental Association (JADA), published monthly, is the ADA's flagship publication and the best-read scientific journal in dentistry. For more information about the ADA, visit ADA.org. For more information on oral health, including prevention, care and treatment of dental disease, visit the ADA's consumer website MouthHealthy.org.




Wednesday, May 22, 2024

Change Healthcare Announces that Recent Hack Compromised Patient Data

 


As almost everyone is now aware of Change Healthcare, which is owned by United Healthcare, suffered a massive data breach in February of 2024.  The breach was so severe that it ended up forcing Change Healthcare to take all of their systems offline, although it may have been a Ransomware attack that encrypted data making it inaccessible.  Encryption was the likely culprit because Change Healthcare ended up quickly paying a ransom of $22 million to the perpetrators in order to get things back to even a semblance of working order.

This breach affected a "significant portion of the US population" while also having a major impact on the entire US healthcare system.  When Change Healthcare went down it brought their payment services to a screeching halt meaning hospitals, doctors, and pharmacies couldn't file claims or be payed for claims they had already filed.  I've spoken to several doctors that have stated that even now, over three months since the February 21, 2024 breach, they are still awaiting payment on multiple claims.

Now comes word that in addition to the payment problems, patient data was also compromised.  It seems that the hackers posted 22 screenshots on public facing websites that revealed PHI (Personal Health Information) as well as personally identifiable information.

If you have been affected by this hack, you can visit a page with more information that was created by UnitedHealth Group.  

The federal government has also gotten involved in this situation and has created a webpage that provides more information for anyone affected.  

At some point (if it hasn't happened already) some unfortunate patient is going to die due to something akin to this.  This breach caused hospitals to cancel some surgeries, patient records were inaccessible, and some patients could not get needed prescriptions.

Healthcare companies are being increasingly targeted by these Ransomware groups and while I don't personally have the answer, experts need to figure out a way to stop these.  Patient lives are at stake.

Tuesday, May 21, 2024

Looking to Improve Your Composite Outcomes? Take a Good Look at PinkWave™


 

I've spent many years in dentistry.  The thing I like the most about that, is that it gives me a really unique perspective on where we are because I know firsthand where we've come from and how far we've progressed.

When I was being trained, adhesive dentistry was in its infancy.  True story: when I was in school we had to get every step inspected and checked off.  We had to have someone check our etching for bonded composites, and if there was ONE speck of the etchant on dentin, you were in big trouble.  Prevailing theories at the time said that etching dentin would kill the pulp.  Of course, then along came my friend Dr. John Kanca and the world changed.  Suddenly total etch and wet bonding exploded across the profession.  Dr. Kanca took a lot of flack for his initial position on the subject, but he's a really smart guy and he was proven to be correct in a relatively short time.

When I started in the profession, composites were rare things.  I placed predominantly amalgam restorations for the first part of my career.

Jumping forward to today, things have changed radically from the old days.  At this point in my career, it's been about 2 decades since I placed an amalgam.  And over the years of progress, I've spent a lot of time studying and learning about adhesive dentistry.

The one thing I like to say is that curing is the 'step child' of adhesive dentistry.  By that I mean, that everyone knows about it, but it doesn't get the attention attention it deserves.  Most of us tend to think that we put the light on the material, wait a few seconds, and then go on to the next step.

However, I can tell you absolutely, that curing is one of the most important aspects of bonding.  If your light isn't strong enough or if you fail to cure for the proper time, all kinds of problems can result.  So, we need to pay attention to curing and better understand the physics and chemistry involved in it.

Today's post is about the PinkWave™ curing light from Vista-Apex and I'm going to spend the rest of the post explaining why I love the science behind it.

In the simplest terms, the light needs to reach every aspect of the material to achieve proper photo-polymerization.  That's one of the reasons (but not the only one) why for many materials, we place them in 2-3mm increments.  At that size, the increment is small enough for the light to penetrate all the way through it.  Some materials today are bulk cure or "large increment cure" with manufacturers creating composites that are a bit more translucent to help the photons reach deep into the restoration.  The deeper the light penetrates, the better the cure.

PinkWave™ handles this depth of cure situation with a unique solution.  The light uses FOUR different LED wavelengths (QuadWave™) to provide increased polymerization and the resultant depth of cure those wavelengths provide.

For the science minded readers, like me, those 4 LEDs provide standard blue, red, NIR (near infrared), and UV to penetrate the beam deep into the restoration.  This combination of light gives PinkWave™ a stated depth of cure up to 8.5mm... which is incredible.

The extra wavelengths have the physics necessary to enhance the cure and the resulting depth of cure, which is SO important for restoration longevity.  And that goes for even the incredibly high mw/cm2 output.  Light intensity doesn't always translate to depth of penetration. which is something that isn't always well understood.  That, in my opinion, is the genius behind PinkWave™.  

The blue LEDs are what activate the photo-initiator (CPQ) which is what most composites use.  However, *some* composites use a different photo-intiator that doesn't use blue to cure.  For those composites, that's where the UV LEDs come into play.  That makes PinkWave™ a truly "broadband" light that will effectively cure any restorative material.

The purpose of the red and NIR (near infrared) LEDs is to gently warm the material.  The wavelength of these LEDs allows them to  penetrate deeply into the material and warm it.  This increases the amount of polymerization that occurs.  Of course heating the material probably triggers concerns in your mind.  Some of you are probably thinking, "what does that do to the pulp?"  Let me put those fears to rest.  The team at Vista-Apex did *extensive* testing in that area and I can tell you with certainty that while it warms the material, it has no effect on the pulp or the tooth.

I always place warm composite.  I have for years.  Multiple studies have shown that warm composite cures more completely.  Warming the material 'energizes' the composite monomers so that the material cures much more completely.

Another great feature of PinkWave™ is in the optics.  Most curing lights work best right at the tip as the photons exit the device.  However, Vista-Apex uses a lens to focus the energy, not at the tip, but at a point 5mm away from the lens.  That puts the energy into the composite where it belongs.

Basically, the device warms the composite AND puts the beam right where it needs to be which results in a deeper, more complete, and better cure. 

If you've been looking for a way to get better clinical outcomes, follow this link and checkout PinkWave™.  I think you'll be impressed.  Curing lights are not all created equal and I feel PinkWave™ is created to perform better.


 

Monday, May 20, 2024

Walmart Announces Closure of Health Centers & No More Dental Care in Stores

 


On April 30th, 2024, Walmart made the announcement that it is closing its health centers and virtual care service stating they were having difficulties finding success with the offerings.  The initiative was launched in 2019, but since the company has had a tough time in the market of health.

This translates to also closing any dental services the company was offering.

The company had opened 51 health centers in five states and had worked on expanding its telehealth program, but stated "there is not a sustainable business model for us to continue".

Walmart stated that "the challenging reimbursement environment and escalating operating costs create a lack of profitability that make the care business unsustainable for us at this time."

They had previously announced plans in March 2023 to open 28 health centers in 2024.  These would have been focused in Dallas and Houston.  The company had also planned to open centers in Phoenix and Kansas City.

As practicing dentists know, the business side of things has been more difficult since the pandemic and it seems that even major retailers entering the market have experience similar issues.

The Associated Press has a more detailed story, which can be found by following this link.  

Thursday, May 16, 2024

Formlabs Dental Announces FDA Clearance for 2 New 3D Printed Mouthguard Resins


As we all know, he world of dentistry is constantly evolving, and 3D printing is rapidly changing how dental professionals operate. Now, comes the introduction of two new FDA-cleared resins from Formlabs, which allows for creating comfortable and effective mouthguards directly in-house.  

This blog post dives into the news of Dental LT Comfort Resin and Dental LT Clear Resin V2, providing a clear (pun intended) picture of the benefits they offer to both dental professionals and patients.

Innovation Meets Convenience: FDA-Cleared 3D Printing

For years, 3D printing has held immense promise for the dentistry. Now, with the FDA clearance of Dental LT Comfort Resin and Dental LT Clear Resin V2 by Formlabs, this potential is being realized to a greater degree. These resins allow dental practices create custom-made mouthguards directly on-site, eliminating the need for traditional impression methods, stone models, and external labs.

Dental LT Comfort Resin: Enhanced Comfort 

Dental LT Comfort Resin prioritizes patient comfort with its flexibility. This resin is ideal for patients who clench or grind their teeth, as the flexibility helps to absorb impact and reduce pressure on the jaw. Additionally, the material is easily polished to a smooth finish, maximizing comfort during wear.

Dental LT Clear Resin V2: Superior Optics and Durability

Dental LT Clear Resin V2 (the second generation of this resin) offers impressive aesthetics with its high optical transparency. This makes it a good choice for patients who desire a more discreet mouthguard. This resin also boasts long-term durability, ensuring the mouthguard can withstand regular use.  We've all see patients literally 'chew through' an appliance and this should help in that regard.

Benefits for Dental Professionals

The introduction of these FDA-cleared resins offers advantages for those of us in the profession:

Faster turnaround times: In-house 3D printing eliminates the need to wait for external labs, allowing for quicker delivery of mouthguards to patients.

Increased patient satisfaction: Offering comfortable and aesthetically pleasing mouthguards can significantly improve patient satisfaction.

Streamlined workflow: 3D printing allows for greater control over the entire mouthguard creation process.

A Brighter Smile for Everyone

The availability of FDA-cleared Dental LT Comfort Resin and Dental LT Clear Resin V2 marks a step forward in dental 3D printing. These innovative materials help dental professionals to provide patients with comfortable, effective, and custom mouthguards, ultimately leading to a healthier and happier smile for everyone.  I often tell patients that we can build mouthguards much more easily than we can build back a worn dentition.

Considering 3D Printed Mouthguards?

If you're a dental professional interested in learning more about how these FDA-cleared resins can benefit your practice, head over to the Formlabs Dental website and check out their 3D printing solutions. You can also consult with a dental equipment supplier to discuss these materials and determine if they're a good fit for your needs.