What happened this week at the ITC?

The rumor mill has been spinning overtime, so let's make a few things clear:

  • Align has not won any of their suits against us.
  • We are still making aligners.
  • Nothing has changed.

First, a quick recap. As you probably know, our good buddies at Align have a long history of suing their competitors. This doesn't usually work out that well for them—Align has had patent claims invalidated and they've paid out tens of millions of dollars in settlements.

But old habits die hard, and they've stuck to this strategy against us. In March 2011, Align sued us in California and Texas, and in March 2012, they filed two complaints with the ITC. These cases take a long time to play out: nothing significant has happened in the California case, and the Texas case is on hold. The first ITC complaint was decided in our favor this January.

This week, Administrative Law Judge (ALJ) Rogers issued his initial determination for the second ITC complaint. His opinion was that ClearCorrect did not violate Align's product claims, but Align's method claims were violated. Naturally, we disagree with that opinion. Regardless, here's what you need to know:

  1. This is not the final ruling on the case. The ALJ's initial determination will be reviewed by the ITC before they make their final decision, scheduled for September 2013. Then that decision is likely to be appealed in the U.S. Court of Appeals for the Federal Circuit. The ultimate conclusion is probably still years away.
  2. In the previous complaint, the ITC reversed this same judge's initial determination and ruled in our favor.
  3. We don't have to do anything differently right now. There's no effect on our day-to-day operations until the ITC makes their final decision.
  4. This initial determination has been incorrectly reported as "a ruling to block U.S. imports of a competing product by ClearCorrect." We make our aligners right here in Houston, Texas, so it's impossible for the ITC to block us from "importing" them. The only "imports" at stake in this case are digital files transmitted by diagnostic technicians in Pakistan. (We've argued that data transmissions shouldn't even be considered imports.)
  5. Align's legal VP recently claimed to investors that if the ITC ruling went their way, "ClearCorrect will be excluded from the domestic market." That's simply not true. Even if the ITC rules completely in Align's favor, we can continue manufacturing and selling aligners in the U.S. The only thing the ruling will determine is how and where we can stage the treatment plans.

In short, don't panic. We're sticking around. We've just invested in scaling up our production capacity by 30%, and we've got a really cool announcement to share with you tomorrow. Until next time…

Update: Align put out a second press release shortly after this was posted, but nothing has changed. The "cease and desist orders" they refer to are just the ALJ's recommendations from his initial determination. As explained above, the ITC is not expected to make a decision until September. If the ITC does issue cease & desist orders, they will apply only to imported data—our ability to design, manufacture, and sell aligners in the U.S. is not at risk.

Tech Tip: Accidental overcorrection

We've talked before about how important it is to express your intentions clearly when you request a case revision. (See this previous tech tip for details.) Taking a few moments to double-check your revision form can save a lot of wasted time down the line.

Here's one issue that's tripped up a few doctors: they check the box requesting overcorrection of a tooth, but then provide conflicting instructions elsewhere on the form.

When you request overcorrection, this indicates to our technicians that you'd like to continue moving teeth in the same direction as originally planned -- just with a little extra pressure. If we got a form with conflicting instructions like this one, we'll have to guess which instruction to follow, and we won't always guess right.

If you don't want overcorrection, don't check a box in the tooth chart. Just list the teeth by number in your written instructions.

Update: To prevent this confusion, we've removed the tooth chart from the case revision form. If you want overcorrection, just request it in your written instructions.

Tech Tip: Answering your patient's Phase Zero questions

The appointment when your patient receives Phase Zero and views the treatment setup is often the most anticipated appointment. This is your patient's first experience with aligners, and they are usually anxious to start treatment and see results. If you help your patient view Phase Zero as an opportunity to get used to treatment, they will be mroe compliant with your instructions and confident in their progress.

This week, we're providing answers to questions that your patients might ask about Phase Zero.

What does Phase Zero do?

Phase Zero is a set of passive aligners that helps you get used to treatment while your active aligners are being planned and manufactured. During this time, you'll get used to cleaning your aligners, get lots of practive applying and removing them, and start to adjust to any "lisp" or foreign feeling they cause. After wearing Phase Zero, you should be comfortable wearing aligners.

Will Phase Zero move my teeth?

No. Phase Zero aligners aren't designed to move the teeth. They're passive -- just like a retainer. They help your teeth stay in the position they were in when your doctor took your impressions, so that your first active set of aligners will fit and you can start treatment right away.

Phase Zero is really uncomfortable. Is there something wrong?

It's not unusual to feel a little bit of pressure or discomfort when snapping in the Phase Zero aligners for the first time -- especially if you're never had orthodontic treatment. However, this doesn't necessarily mean that there's a problem. As long as the aligner fully seats over your teeth, you're good to go.

To help ease the discomfort and pressure of a new aligner, try soaking them in warm water or biting down on some Chewies.

What happens next?

If Phase Zero fits well, your doctor can approve the treatment setup, and ClearCorrect can start planning & manufacturing phase 1. If Phase Zero doesn't fit, your doctor will probably want to take new impressions and send them in.

Have you run into any other questions during Phase Zero fitting appointments? Let us know how you answer them in the comments.

Introducing Phase Negative One™

It's been over a year since we introduced Phase Zero™—an initial set of passive aligners that gets patients acclimated to clear aligner therapy as quickly and gently as possible.

Now we're proud to announce the latest revolution in orthodontic technology:
Phase Negative One.

Traditionally, the amount of correction that can be achieved with clear aligners has always been limited by the initial malocclusion of the patient's teeth. It happens all the time—patients come into your office begging to wear dental appliances like their friends and colleagues, but you have to turn them away because of their perfect Class I bite relationships and flawless, straight teeth.

That's where Phase Negative One comes in. It's a set of clear misaligners that distorts teeth into a more aesthetically-displeasing configuration before treatment begins. Now everyone can enjoy clear aligner therapy—even those who were unfortunate enough to be born with naturally perfect smiles.

Before, During, and After Phase Negative One

Phase Negative One can be customized to create almost any type of issue you and your patient want to solve: from overjet and diastema to whifflebite and houndstooth.

Best of all, Phase Negative One reduces turnaround time to less than zero. The more inaccurate it is, the better it works, so you can have the misaligners ready in your office even before your patient's first appointment, without taking impressions at all.

Phase Negative One is available as a -$95 downgrade to any treatment option starting today, April 1.

Warning: Results may vary. Available by prescription only. Use of Phase Negative One may violate local, state, and federal regulations, Hippocratic Oath, and principles of basic common sense. Offer not valid on major continents or outlying islands.

Tech Tip: Preventing air entrapment in impressions

In light of our recent tech tip, Dr. Rick Gennaro sent in a great tip from an experience reviewing problematic impressions in a friend's lab:

I was shocked to see how poor the majority of impressions were. Improper tray selection, re-seating the tray, combining unrelated materials (i.e. PVS with polyether), inconsistent mixing, air entrapment, etc., all contribute to the problem.

A lot of what I saw, aside from inadequate preps and poor tissue control, was a simple issue of not having cleaned off the teeth and tissues, leaving behind debris and fluid. Unclear details and air bubbles were prevalent, and this was from several dentists. Cleaning with peroxide and washing would have helped greatly.

Cleaning the teeth and gum tissue before impressing to remove plaque, fluid, and other buildup creates a clean slate for the PVS material. Also, if you've already taken multiple impressions on the same patient in one sitting, be sure to clean the teeth before re-impressing each time. This improves detail and prevents air entrapment. 

Air entrapment can also occur when dispensing the material, if you're not careful.  If you lift the tip of the gun while dispensing, it can create pockets of air within the material that distort the accuracy of the impression. To prevent air entrapment, keep the tip of the gun down and dispense the material evenly, as Dr. Pumphrey demonstrates in this video.

Thanks for the tip, Dr. Gennaro! How do you achieve the best results with your impressions? Share your own experience in the comments section below.

Tech tip: The anatomy of a good impression

A high-quality impression is the foundation of a successful case. Whether for a submission or a revision, accurate impressions are vital to ensuring that treatment is effective and time-wasting delays are avoided. 

We've listed our guidelines for a good impression below. Follow along and view an example of an excellent impression on our printable guide:

Detailed, accurate occlusal surfaces.

A clear impression of the occlusal surfaces ensures that the aligners will have a tight fit.

  • Sharp cusps

  • Tray doesn't show through impression

All gingival margins are defined and clear.

Defined gingival margins ensure enough retention points are present for effective tooth movements.

  • Includes about 2mm of buccal and lingual surfaces outside gingival margin

Distal surfaces of molars are captured.

This is a common cause of missing retention points and fitting issues during phase 0. If your patient has short clinical crowns, getting a clear impression of the molars is especially important.

  • More than half of each molar is visible

Impression material is intact.

Damaged or thin impression material compromise the accuracy of the molds and resulting aligners.

  • No damage, warping, or separation of light and heavy material

No imperfections in the impression material that compromise dental anatomy.

Imperfections or double imprints in the impressions could affect the effectiveness of treatment with the resulting aligners.

  • No bubbles, voids, thin walls, shifts, or double imprints

More Helpful Tips:

  • Make sure the tray is not too small and fits your patient well. If the teeth are touching the edges of the tray, the tray is too small.
  • Use plenty of PVS material. It's better to have too much than too little.
  • Remove all engagers prior to taking the impression. We need impressions free of attachments to make accuracte molds.
  • Fill in black triangles with wax. This will allow you to remove the material cleanly without creating pulls or distortions.
  • Refrain from moving the material as it sets. We recommend waiting an additional 60-90 seconds longer than instructed before removing the trays from the patient's mouth.
  • Don't forget the light body material! Add the light body before the putty or heavy body dries completely.


Tech Tip: Make your case revision form more effective

For this week's tech tip, we're sharing an observation from our account reps. We often receive case revision forms that simply state:

"The trays aren't fitting."

While this may be a true account of what's happening in your case, we would need more information than that to ensure we process your case revisions successfully. Because our role as a dental lab is to follow your instructions, we need as much detail as possible to accurately respond to the issues in your case.

Note: As we've said before, fitting issues do not always require a case revision or new impressions. You may be able to prevent an unnecessary case revision by following these troubleshooting techniques to get your patient back in treatment.

If you've tried troubleshooting and are closely managing the case, but problems continue to arise, follow these tips to submit a more complete case revision:

  • Write everything down. The more information you give us, the better. Our technicians use all of it to work with to make your next set of aligners as accurate and effective as possible.
  • Note misbehaving engagers. Engagers that aren't tracking point to bigger problems than fitting issues. If you've followed these engager troubleshooting tips but issues still arise, let us know on the case revision form.
  • What troubleshooting techniques didn't work? Our technicians will have a better idea of how to re-route your patient's treatment if they know what steps you've already taken to correct fitting or tracking issues. Make sure to note these in your case revision form. (If you haven't tried any of our troubleshooting techniques, you probably should do so before submitting a case revision.)
  • Is your patient really compliant? Non-compliance is the leading cause of fitting or tracking issues experienced during treatment. Though your patient may promise that they've worn their aligners for 22 hours a day, you may want to stress that compliance is essential to achieving the best results during treatment. Check the treatment plan for any indicated Compliance Checkpoints. These are usually a good way to see if the patient is wearing their aligners as much as they should be.

Do you have any other questions regarding case revisions? Drop us a line in the comments, and we will answer your questions in an upcoming tech tip.

What's new in 2013

Happy New Year! We hope you had a great holiday break.

The new year is an opportunity for patients to reinvent themselves with a new smile, and it's a great time for doctors to try something new as well. With that in mind, let's take a look at…

What's new in 2013

We said they were coming, and now they're here: ClearCorrect’s new treatment options.

To refresh your memory, the new treatment options are:

  • Limited 6
  • Limited 12
  • Unlimited

Case evaluations are also available if you need a little help getting started, as are standalone retainers.

From here on out, all new cases will be processed as one of these case types: Limited 6 is a super-affordable option for minor anterior adjustments and ortho relapses. Limited 12 is great for cases with a couple of millimeters of crowding or spacing to correct. And Unlimited is the most flexible, no-worries option you can get: as many aligners as you need until the case is closed.

The fine print

The full details of the policies and pricing for these cases are spelled out in our updated terms & conditions. I know it's probably hard to imagine anything more boring, but you really should take a few minutes to look them over. They apply to all cases, not just new cases submitted in 2013.

We've clarified a few policies regarding how long cases can remain open. For instance, cases will be automatically closed after 180 days of inactivity—if it's been almost six months since you got your patient's last phase, time may be running out to request a final retainer or a revision.

Also, case revisions must be submitted within 3 years of the original submission. If you have any patients who started treatment back in 2009 and then drifted off without wrapping things up, it's too late to start the case back up and request refinements now. (We will still ship any already-planned and paid-for phases for older cases, even if they're 3 years old.)

If your patient hasn't been wearing aligners for a while and falls into one of these categories, your best option for doing a little touchup treatment is going to be to submit a brand-new Limited 6 case. (See, we told you they're good for ortho relapses.)

You might also notice a minor change we've made to our payment processing. We used to wait to charge lab fees until we had received all required records (photos, impressions, etc.). We're now charging the lab fee as soon as cases are submitted. We've updated our sample timeline to reflect this change.

Thank you again for being ClearCorrect providers. We can't say it enough. Together, we'll make this our best year yet. Until next time…

New volume discount program

In last week's announcement of our new treatment options for 2013, we mentioned that we're also starting a new volume discount program.

This week, we've got the details on that, plus some answers to your questions from last week, and a reminder about a workshop discount that's going away at the end of the year.

Take five, Five for Five

You may be familiar with our previous volume discount program, called Five for Five. As you submitted cases, you could accumulate credit to be used the next quarter, depending on how many cases you submitted in the quarter.

If you weren't familiar with it, don't get too attached, 'cause it's going away.

Instant gratification

Our new volume discount program delivers instant discounts on Unlimited cases throughout the quarter.

The discounts kick in with a bang after you submit 10 Unlimited cases—the 11th Unlimited case submitted each quarter is free.

After that, the discounts really start to add up. You'll be able to take $100 off your 12th–25th Unlimited cases, $200 off your 26th–35th, and then $300 off Unlimited cases for the rest of the quarter. You'll get your discounts right away, instead of waiting months for an account credit or rebate check.

We know that a lot of you aren't going to treat enough patients to qualify for these discounts. That's why we've made our regular lab fees so affordable; so clear aligners can be accessible to as many people as possible.

However, we wanted to make sure that we were also offering the best available price to doctors who do run high-traffic practices. The discounts are bigger now, and they're available as soon as you earn them.

It's important to note that only Unlimited cases count towards the discount, and only Unlimited cases qualify to be discounted. The incredibly low lab fees for Limited 6 and Limited 12 cases are already available to everyone, regardless of volume.

Q & A

Now to answer some of your questions about the new treatment options:

Q: Can I still submit a Limited or Full case after January 1, 2013?

A: No. The Limited and Full case types are being discontinued on January 1, 2013. Any case submission form that we receive after January 1 will be processed as Limited 12 if it says "Limited" and as Unlimited if it says "Full".

Q: Will I still be able to buy extra phases for my existing Limited & Full cases?

A: Yes, you can still buy extra phases for legacy cases only. Or you can upgrade those cases to Unlimited by paying the difference in their standard lab fees. Any additional fees you've paid over the life of the case (for instance, for shipping, replacements, or extra phases) won't be credited towards the upgrade cost.

Q: I bought a voucher for a Full case. Is it still valid?

A: Yes. If you submit a case with a valid Full voucher after January 1, 2013, we'll process it as an Unlimited case at no additional charge. Cases already started as Full will remain Full unless you choose to upgrade them. (Don't forget to use those vouchers—they expire one year after purchase.)

Q: I've earned Five for Five credit in the fourth quarter of 2012. Can I still use that?

A: Yes. Any Five for Five credit you earn this quarter can be applied next quarter. However, starting January 1, 2013, the Five for Five program will be replaced with the new volume discount program, so you won't earn any additional Five for Five credit after that point.

Q: Which treatment option should I choose when I submit cases in 2013?

A: In general, anything you currently submit as Full will be Unlimited, and most Limited cases will be Limited 12. Limited 6 is ideal for minor anterior movements that can be completed within 6 steps. We'll offer more information to help you choose between case types next year.

New treatment options for 2013

Note to consumers: Our lab fees are confidential. Which is a shame, because they’re really worth bragging about. If you’re a dentist or orthodontist, give us a call at (888) 331-3323 to get the full scoop. If you’re already a provider, details are available on our wiki.

We’re excited to introduce our all-new treatment options, available starting January 1, 2013.

We tested countless variations before finalizing these options. Based on the feedback we’ve received from doctors, we think these new options will provide the greatest combination of affordability, flexibility, and predictability ever available for clear aligners.

Let’s get started, shall we?

Limited 6 — $███

We believe this will be the most affordable clear aligner treatment option available in the industry.

The Limited 6 is ideal for simple anterior adjustments. It includes up to 6 steps of clear aligners (single or dual arch). That’s more aligners than the competition, offered at a lower price. This price is not a limited-time promotion—it’s our everyday lab fee.

Like every ClearCorrect case, this comes with a treatment setup, and (unlike the other guys) Phase Zero and retainers are included at no extra cost. (We could have called this Limited 8, but we didn't want to rub it in.)

Limited 12 — $███

Cases you currently submit as Limited will be treated as a Limited 12, starting January 1.

It’s very similar to what you’re familiar with—you still get up to 12 steps of clear aligners, plus a setup, Phase Zero, and retainers. There's still no fee for revisions, so long as you stay under 12 total aligners. Up to 2 free replacement aligners are now included, and they won't count against the 12 steps allowed for your case.

Unlimited — $███

This is a biggie. If Limited 6 is the most affordable clear aligner option in the industry, this is the most flexible and predictable.

Starting January 1, any cases you currently submit as Full will be treated with the new Unlimited option. It's pretty simple to explain: you get as many aligners as you need, until the case is closed. That includes unlimited revisions for up to 3 years and replacements for any step at no extra cost. Seriously.

While you take a minute to let that soak in, I’ll just mention that the Unlimited lab fee can actually sink as low as $███ with our new volume discount program. (More on that another time.)

We'll also be offering case evaluations and standalone setups to lower the barrier to entry even further. And you can upgrade any case (including legacy Limited and Full cases) to a more comprehensive treatment option just by paying the difference in lab fees. We've added answers to most of your questions about these changes on the wiki, and we'll introduce updated terms & conditions soon with full details.

It’s the same great ClearCorrect product you're used to, now even more flexible and doctor-friendly.

What’s the catch?

As the sharper-eyed among you may have noticed, the Limited 12 and Unlimited lab fees are slightly higher than the current Limited and Full options. We haven’t raised our prices since we started 6 years ago, and we don't plan to do it again any time soon.

Here's why we're making this change now:

  1. We heard your feedback: you love the flexibility of phase-based delivery, but you don’t like keeping track of unused phases, or paying for extra ones. We've eliminated that hassle by creating the new Unlimited option. Increasing the lab fee slightly makes that feasible.
  2. The increases are partially offset by the introduction of Limited 6—our most affordable treatment option ever.
  3. This keeps us in line with inflation, and will allow us to continue to expand and improve our product.

If you want to submit cases before this price increase goes into effect, we totally understand. Any cases submitted by December 31, 2012 will be handled just like they are today, and charged at the current rates. Next year, you’ll have the option to upgrade those cases to the new treatment options at any time just by paying the difference in the lab fee.

I’m sure you want to know more. First, check out the wiki. If you still have questions, post them in the comments, and we'll include our responses in the next tech tip.

Until next time!