Topics of the day:

1. Digital radiography
2. Fee breakdown for transfer patients
3. OrthoClear
4. OrthoClear, Invisalign, what's the difference?
5. ESCO - The Electronic Study Club for Orthodontics

Dear ESCO friends

At last my conventional radiographic equipment is gradually dying. So now the time has come to switch to digital radiography. Any suggestions, tips, recommendations? Is it preferable to go fully digital or use the "indirect" way using a scanner like Duerr's or Gendex? Thank you very much for your help.

Frank Weiland, DMD, PhD
Deutschlandsberg, Austria

What could be recommended as some sort of "standard", if there is such a thing, or, if not, your individual ideas on percentage fee breakdown for a patient being transferred? For instance, what percentage for banding and bracketing, percentage for months of treatment, percentage for de-banding and retention?, etc.

Thank you,
Marty Grogin

I thought you might like to see the new version of aligner treatment called OrthoClear coming out now from Zia Chishti, the founder of Align Technology and formerly the driving force behind the Invisalign system until he was ousted by the corporation.  I don't recall the dates, but I think Zia was terminated from the Align Tech corporation sometime after the company's stock dropped following the U.S. attacks in Afghanistan and Iraq.  As you may recall, Align Tech had a technology center in Pakistan with 400 skilled employees doing their treatment animations (ClinCheck) on computers, but the company dumped that factory location and took a charge-off because of the perceived instability in the region.  Zia apparently opposed that move. Eventually, they parted ways.  Zia now has started up a Pakistan facility and the new U.S. company has hired away key people from Align Tech in the US, including software engineers and many sales people. They came up with a new way to make aligners, which he and his lawyers apparently think circumvents the patents of Align Tech. Align Technology is suing him for patent infringement, breach of contract (maybe a non-competition agreement?), and theft of trade secrets and personnel.  OrthoClear is counter-suing. The court apparently issued a
temporary restraining order, prohibiting OrthoClear from hiring any more Invisalign employees until the case is resolved. I don't know any details of the lawsuits, but it generally takes years before they have any impact on either party's operations. However, the news has caused some stock analysts to downgrade Invisalign's stock.

His new start-up company is called OrthoClear.  They had a simple booth at the recent annual AAO meeting in San Francisco, which I attended.   I thought you'd like to know what I've gleaned from the encounter.

Zia Chishti is a very up-beat entrepreneur -- something like Steve Jobs of Apple computer.  He says some of his same catch phrases you may have heard on Align Tech videos:  "The apparent simplicity belies the underlying complexity of the system."  He's a charismatic leader, I think, which may explain why he could pull so many employees from Align Tech.  He's very positive about their prospects for the future:  "10 years from now, all of this will be gone (waiving his arm across the exhibit hall) and there will only be aligners."  [I think not, but aligner treatment is here to stay and probably will improve with more innovative thinking.]

The new scheme doesn't use the same methodology as Align Tech, but it's similar.  Align's current technology is this, as I understand it: Doctor ships PVS impressions to Align's Santa Clara California facility. There, the impressions are scanned and digitized by a high-precision industrial CAT scanner.  The surface point locations are fed into Align's computer programs to create a virtual model, register the upper and lower into the PVS bite registration, slice the virtual model into separate teeth, manipulate the teeth (by a tech on a computer screen) into a final occlusion, and then sequence the movements of the teeth in small steps from beginning to end.  This animation is what the doctor views on his ClinCheck program in his own computer.  Comments can be sent back to the Align Tech technician to make changes to the treatment steps until the doctor is satisfied.  Then Align Tech uses machines called "SLA" devices, which create physical models from the virtual model data for each of the treatment steps in the animation.  On these models, the
individual aligners are made using traditional dental lab equipment (Biostar).  Then Align ships all of the aligners for the whole treatment to the doctor.

The OrthoClear process (as I understand it so far) is this:  Doctor sends PVS impressions to OrthoClear.  They box up the incoming
impressions and air-ship the batch in a big carton to Pakistan. OrthoClear employs only about 6 people in the San Francisco
headquarters, not counting outside sales reps.  Their entire operation is in Pakistan.  (I suppose Zia hired the experienced employees that Align Tech had laid-off a few years ago.)  There, the dental techs pour up the impressions to make casts (maybe not gympsum, though).  I think some sort of alignment device is used, maybe like the brass posts that are used to make removable dies for crown & bridge. Zia was very tight-lipped about what goes on in the process.  He said it will be revealed in about a year, after the patents are published by the US Patent & Trademark Office (USPTO).  Meanwhile, they are trade secrets.

Zia said they are not using the SLA process.  Instead, OrthoClear is working "in the physical, not the virtual world" to make the aligners. This explains why their aligners don't have the layering effect (which looks like a contour map) created by the SLA machine as it lays down layer after layer of light-cured plastic to build up the physical plastic models upon which aligners are fabricated. Instead, OrthoClear uses their trade secret process to physically position the cut-apart cast teeth.  The aligners are made on casts cut to preserve the real contours of the gingival margin.

The cut apart teeth are scanned to digitize them so the doctor can view the pre-treatment and setup of the final positions desired.  The
digitized virtual models can have "gums" created by the computer program (similar to Invisalign), or the virtual gingiva can be switched
off by a click from the doctor to reveal the underlying cut-apart teeth, a portion of the real gingiva, and pseudo-roots that are put on
them.  (See the attachment I've sent with a photo of the computer screen from the show display.)

The doctor can click on a tooth; it changes color to indicate it has been selected, and then using arrow buttons in the GUI (graphical user interface) he/she can manipulate the individual tooth: rotation, tipping, torque, in-out, etc.  This way the doctor adjusts the desired final result occlusion.  When approved by a mouse click, the program signals the techs to get to work on making the first movements toward that final result, not all the way there.  Unlike Align Tech, OrthoClear does not animate the entire treatment all at once. (In fact, they don't do any animation that we can see.) Instead, they only do two treatment "steps", which would create two pairs (upper and lower) of aligners to be worn for 3 weeks each.  The aligners are shipped and the doctor delivers them.  Six weeks later, another pair is needed to continue the treatment, so OrthoClear ships the next pair to arrive in time. Meanwhile, the doctor has about a 10 day period, in each 6 week cycle, when he can get on his computer and interact with the tech by making text comments (not manipulating the virtual model, at least not at this time in their development of the system) before the new set is made.  Just as with the Invisalign system, the tech back in Pakistan tries to make the changes the doctor requested, so the next sets of aligners will be made to the doctor's orders.  However, since the Invisalign system makes ALL of the aligners at the start of treatment, there's no way to make changes without "re-booting" with a new impression for Align Tech to re-process.   OrthoClear gives the doctor a chance to make mid-treatment changes -- it's more interactive, somewhat like conventional fixed appliance treatment, where you can see how the appliance is working and make changes as you go.

Buttons can be added or deleted during the treatment. Rate of movement can be slowed down or sped up.  Sequences can be altered ("do all of the expansion before moving that tooth", for example).  This is intended to be more like conventional fixed appliance treatment:  you make an appliance change, see what it does, stop it when it's gone far enough, change it if it isn't doing what you want, etc. You can send in new impressions at any point in treatment and "re-boot" the process from that point if you are losing control. Unlike Invisalign, since you don't have several boxes of aligners on the shelf that suddenly become obsolete when you re-boot, you are less inclined to stick with a losing plan.  Also, you don't have such a large storage problem as with Invisalign.

There are some other little differences:  The "attachments" on the teeth (little humps of composite you bond to the teeth to give the
aligners a grip for certain movements) are grabbed not just by a dimple in the aligner, but rather by a hole in the aligner which gives more of a snap fit.  This may prove to be a better way to control certain movements. No research on that was shown at the display.  Also, the aligner material seems to be clearer, more like the original Invisalign material.  The aligners are to be worn for 3 weeks, not 2 weeks, so maybe this was to circumvent a patent claim in the Invisalign patent. The movements are .3 mm instead of .2 mm.  And, unlike Invisalign, the diagnostic virtual setup has pseudo-roots.  These aren't the patient's real roots digitized, of course, because the 3d data for that isn't available on the records we send.  Maybe someday we'll be sending cone- beam CAT scan data and they'll get the patient's own roots on there, but for now, they just add little cones where the roots would be, to show the long axis -- better than nothing.  I don't know if the computer program uses the root length to modify how tipping occurs. That would be good, but most likely the roots are just for visual effect at this time. 

I suspect that some of the difference between OrthoClear and Invisalign are there not because of better mechanics but rather to avoid
infringing on an Invisalign patent.  For example, Invisalign's patent says it uses more than 3 treatment steps to treat the malocclusion. I
think that's because they tried to avoid infringing on Ormco's patent for 3 steps exactly ("Red-White-Blue").  So now OrthoClear uses two steps, and then 2 steps, and 2 steps, etc.  Will that work in the intellectual property legal world?  Don't know yet, but the world of U.S. patent law is very strange. so it might just work.

Oh, yes, one more thing:  The fee for OrthoClear is just under $1000 per case (plus a total of $70 shipping for the whole treatment), for up to 24 months of whatever you need--aligners, initial processing, unlimited number of re-boots if needed, and final retention aligners.  If the case needs additional aligners after 24 months, the fee is about $140 for each 3 additional months (shipping included).  Zia says their technique is much more cost-effective because they have lower manufacturing cost by avoiding the SLA process.  (He assured me that the step by step re-positioning of the cast teeth is NOT done by a warehouse full of Pakistani technicians moving them in wax setups.  It is some sort of computer-driven manipulative process.  And that's their magic bullet, patent pending.)

Anyone have more to add about OrthoClear?

Stan Sokolow
Orthodontist
Santa Cruz, California

As I explained in a prior message, a new company has started marketing a system of aligner treatment very similar to Invisalign, called OrthoClear. Here's more information I've gleaned from the Internet.

My prior message speculated that OrthoClear is trying to avoid infringing on the Invisalign patent by producing only 2 aligners at a time. I said that this was to avoid infringing on Ormco's patent for 3- aligner treatment, called "Red-White-Blue", and on Invisalign's patent for more than 3 aligners per treatment. Well, the Ormco patent apparently has been declared invalid by the federal district court in the suit brought by Ormco against Align Technology (the Invisalign company). Moreover, Ormco was declared to be infringing upon the Invisalign patent claims which involve putting sequential numbers on the aligners to indicate the order in which they are to be worn and on shipping all of the aligners in one package for the entire treatment. Isn't patent law wonderfully nuts?!? Are these things "inventions" that patent law was intended to protect? I thought the Arabs invented our numbers a long time ago, and you'd think that putting sequence numbers on things to indicate the order of use or shipping all of the appliances in one box instead of individually is obvious and not patentable, but what's obvious to you and me apparently isn't obvious to the U.S. Patent Office examiner. (And to think that Albert Einstein supported himself by being a patent officer when he first came to the U.S.!)

Anyway, there's a lot more to the story about how OrthoClear came into existence. You can find out more by going to the Align Technology investor relations web site: http://investor.aligntech.com and clicking on Litigation Update. Also see the summary of press releases at MSN Money: http://news.moneycentral.msn.com/ticker/sigdev.asp?Symbol=ALGN .

Stanley Sokolow, DDS Orthodontist Santa Cruz, California

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