What exactly is Toothpillow?

From Toothpillow’s Instruction Manual found on their app:

What devices are used in Toothpillow?

Myobrace® and Vivos® Guides are Class I devices utilized by Toothpillow.

Per the FDA, the devices used within the Toothpillow program are classified as “Preformed tooth positioners”. It is a “plastic device that is an impression of a perfected bite intended to prevent a patient’s teeth from shifting position or to move teeth to a final position after othodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position.

Indication and Usage

Reason the product has been approved for sale on the market.

Toothpillow currently only serves children ages 3-12 years old.

How does Myobrace® work?

Per the NIH, “Myobrace® is an orthodontic device with an interceptive function. It has the aim of re-educating the oral muscles to correct oral dysfunction, predisposing the physiological growing of the jaws, aligning teeth, and optimizing face development.”

“The Myobrace® System consists of a series of intraoral appliances that are worn for one hour a day as well as during the night (during sleep). The Myobrace® is a prefabricated removable device in silicone which is characterized by the presence of a buccal and lingual shield, a tongue tag, and a tongue elevator. The buccal shield discourages the hyperactivity of the orbicularis and buccinator muscles and, therefore, the centripetal force exerted by the vestibular muscles; the tongue tag stimulates the tip of the tongue to find its correct position in contact with the palatine wrinkles, behind the upper incisors, indirectly facilitating the correct lip seal and physiological nasal breathing; and the tongue elevator favors the lifting of the tongue. Furthermore, according to the recent literature, a Myobrace® System can move the mandible forward with a possible increased of the posterior airway space (PAS),”

The device for 2-5 year olds is intended to correct oral dysfunctions by promoting correct chewing and nasal breathing. The device for 6-10 year olds is indicated in cases for dental crowding, correction of open bites, and deep bites due to oral dysfunction habits.

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

From the Myobrace® System manual, “Most moderate malocclusions in the late-mixed or early-permanent dentition can be treated with the Myobrace®, provided that the appliance fits adequately into the mouth. There is a contra-indication for using the Myobrace® in more severe malocclusions merely because the appliance does not adequately fit into the mouth and therefore does not have control in improving dental-alignment.”

Malocclusions are when your teeth are not aligned properly when you bite down. This can mean that your upper and lower teeth don’t fit together correctly, which might cause issues like crooked teeth, overbites, underbites, or crowding of the teeth. In simple terms, it’s when your teeth don’t line up the way they should, which can affect your smile and how you chew.

The manual also states, “Cases with mild to moderate malocclusion should be selected. The Myobrace® needs to fit the patient reasonably well from the commencement of treatment otherwise the teeth will not engage the tooth slots of the appliance. For this reason it is important to first evaluate each case by taking records with models and photos prior to setting a treatment plan involving the Myobrace®.”

Risk of Over-Treatment

From the Myobrace® System manual, “It is important to properly instruct the patient that the Myobrace® must be used for a minimum of two hours per day plus overnight. This must be done on a daily basis or the treatment will not work. The patient should be informed that treatment will need to be suspended if compliance is not acceptable. Conversely, the Myobrace® is a powerful myofunctional and arch expansion appliance and patients should also be advised that excessive use for more than four hours per day can cause excessive and undesirable tooth movement. Patients should not be sent away for extended periods of use with the Myobrace® without close monitoring as the Myobrace® may ‘over-treat’ to an undesirable result. The patient should be informed that it is essential to have these regular reviews for this reason.”

This is why patients cannot purchase this device on their own. To avoid over-treatment, patients can only utilize this medical device under supervision of a trained professional.

Adverse Reactions

As a medical device, adverse reactions are reported to either the FDA’s MAUDE Database (Manufacturer and User Facility Device Experience), CDRH (Center for Devices and Radiological Health) Reports, or Recalls Database. There was only one report concerning these devices, as detailed below:

From the Instruction Manual on Toothpillow’s app:

Regular inspection of your Toothpillow® Guide – Due to stresses on the appliance while you sleep (such as occasional grinding of your teeth) it is possible that the device may break down or become damaged over time. Check you appliance each night before use, and each time that you clean it, check for any damage. If you see any damage, contact Toothpillow® Support immediately to determine if you may still use the appliance, or if a repair or a replacement is needed. Failure to do so may result in injury including swallowing or aspiration (breathing in) of pieces of the device.

Anecdotal Adverse Reactions. The following concerns were submitted by the Just the Inserts community:

• Initial discomfort, pain, soreness in the teeth, jaws, or surrounding areas due to the pressure the device exerts on the teeth and jaw to encourage alignment.
• An increase of saliva production.
• Gag reflex/nausea.
• Difficulty adapting to the device. Some children found it hard to consistently wear it or resisted it altogether. Reasons were mainly discomfort, inconvenience, or not liking the feeling of a foreign object in the mouth.
• Other concerns were with improper use outside of manufacturer guidance, including enamel wear, gum irritation, or cavities if oral hygiene is not maintained.

Here is guidance from Toothpillow’s Instruction Manual:

Toothpillow Wear and Tear

From the Myobrace® System manual, “The Myobrace® is a system that may require replacement of the appliance as it gets worn out. Six months is the average life-span of the silicone. If the appliance is chewed on heavily, particularly at night, wear will be increased and splitting will occur. Not dissimilar to high performance tyres on a car, longevity is not as important as performance. The Myobrace® performs well but often needs to be replaced for continued active treatment. Note that with correct wear, the Myobrace® will wear and split after some months. This is an indication that compliance is good and the parent should be informed that there will be continuing charges for additional replacement appliances.”

Based on the Toothpillow instruction manual, this is why Toothpillow® for Kids is a “three-stage appliance system” over 24 months.

Can it help with OSAS?

According to NIH:

Oral devices, per the above article, may only be appropriate for mild-to-moderate cases of Obstructive Sleep Apnea Syndrome. Per Vivos Therapeutics, Inc., clinical studies “have shown that 12.5-25% of patients may continue wearing a CPAP device.”

Marketing Claims

One of the most discussed concerns was marketing claims surrounding these devices. Here is an explanation from Vivos Therapeutics, Inc. concerning potential benefits of utilizing an orthodontic tooth positioning device:

Is Toothpillow a Scam?

When I first started researching Toothpillow, here was some of the sentiments I came across from non-affiliate accounts:

Is it One-Size-Fits-All?

No. Based on Toothpillow’s website, you must complete an online assessment before being accepted in the Toothpillow program. Severe malocclusions (crooked/misaligned teeth) are contraindications.

What about Myofunctional Therapy?

Per Toothpillow: Myfunctional therapy is crucial for addressing various oral health concerns, promoting proper breathing and swallowing patterns, improving speech, preventing dental problems, and supporting overall health. By focusing on the muscles and their function, this therapy can have long-lasting and positive effects on a person’s quality of life.

There are three myofunctional therapy options within the Toothpillow program. Liken these options to a home project. The first option is to watch DIY videos on YouTube, purchase the materials, and do all the labor yourself. The second is to DIY what you can, and then subcontract the parts you can’t do yourself (plumbing/electrical). With this option, you hire the professionals when you need it. Finally, the third option is to hire a professional service for your home project from the start. Here are the Toothpillow myofunctional therapy options:

• Do the daily exercises provided in the Toothpillow app. These are included in the baseline treatment plan.
• Get a 30 min initial evaluation with a trained myofunctional therapist for customized exercises once a month for 4 months.
• Have 10 virtual visits weekly or bi-weekly with a trained myofunctional therapist for a personalized plan.

Are the Daily Exercises “Cookie Cutter”?

I came across this statement quite a bit while researching Toothpillow’s myofunctional therapy. Concerning the daily exercises provided in the baseline treatment plan, they were designed by Laura Eckhardt. She is a Orofacial Myologist and certified through the IAOM (International Association of Orofacial Myology). Based on her private website, customized myofunctional therapy sessions with her are $200 for the initial evaluation and $80 per 30 min session.

The daily exercises include slow nasal breathing, tip pops, taco blows, tooth cleaners, tip pop hold, lip pops, tongue tip sit ups, 3 ticks/1 tock, molar to molar touch, straw drink, and suction swallows. Each exercise includes a video explaining each one in the app.

What all is included in the treatment?

At the time of this writing, if you are approved by Toothpillow, you can opt to pay monthly ($75/mo) for 24 months or pay up front $1,746. There are discounts for multiple children and payment options like HSA/FSA or 3rd party finance options are available. My biggest question while researching Toothpillow was, “is it worth that much money?” Let’s look at a cost breakdown in comparison to market prices.

Oral Appliance (Three Stages)

An airway dentist in your state will evaluate which tooth positioner device (myobrace/vivos) is best for your child. Some people messaged me they were able to seek reimbursement from their insurance companies for this cost. Toothpillow can provide a treatment invoice for insurance purposes. For example, dental code D8210 is for an orthodontic removable appliance therapy and Z46.4 is for the fitting and adjustment of that device. Most of the messages said they were reimbursed about half of the Toothpillow treatment cost.

Concerning market prices, the price range for treatment at an in-person orthodontic or dentist office ranges from $2 – $5k. This includes the appliance itself and the associated dental visits required over the course of treatment. As discussed in my post on @justtheinserts, over-treatment is a potential adverse reaction, which is why it must be used only under professional care. Just like Toothpillow, this may or may not be covered by insurance.

It should be noted that replacement devices due to wear and tear or if they are lost are not included in the Toothpillow treatment cost. Each replacement is currently $100.

Myofunctional Therapy

As we already discussed, daily myofunctional therapy exercises were designed by a Orofacial Myologist and provide the basic foundation for parents to do with their children. They are not customized, however they do provide a starting point for parents to create a positive myofunctional habit with their children. Many people messaged me they liked the convenience of the exercises within the Toothpillow app and the reminders set up on their phone to do them consistently.

Most of the market prices I came across were for customized virtual myofunctional therapy sessions. They ranged from $80 – $125 per 30 minute session. The fully customized myofunctional treatment option with Toothpillow is currently priced $1,250 for 10 virtual visits ($125/per session).

The Welcome Box

In addition to the oral appliance and its case, the welcome box includes one of the following: Burst Kids Sonic Toothbrush ($39.99), Kids Xlear Nasal Spray ($6.99), Fluoride-Free Himalaya Toothpaste ($5.99), Cheek Retractors for progress pictures (~$3), Mouth Rinse for first time use, Rewards Chart to keep your child motivated, Measuring card and stickers to accurately measure your child’s mouth, and Zollipops as rewards for compliance.

The App

Virtual monitoring from an airway dentist in your state replaces the cost of going to in-person appointments in a brick-and-mortar building. This is where all progress pictures and treatment updates occur.

My Personal Perspective

Recently, I shared on social media that I’ve paid out of pocket over $1k at an airway dentist about an hour from my house to provide oral assessments for my two older children. These assessments included a dental CBCT scan for my daughter and a 5 night at-home sleep study for both of them.

The first phase of the treatment plan based on the assessments was over $30k ($22k for my daughter and $9k for my son). Like many in this community, even though I desperately would love to provide the recommended treatment plan for my kids, I simply cannot afford it.

A few people messaged me similar situations. We feel overwhelmed and depressed that the treatment we know would benefit our children is not within financial reach. Even if we were able to afford it, attending over 14 myofunctional therapy sessions an hour away (one-way) is a logistical nightmare during the school year.

This is when I started to ask the community about Toothpillow as an alternative to an in-person treatment plan I cannot afford. Instead of treating this problem as “all-or-nothing”, I am striving to do the best I can with resources I have. I personally am grateful to have found Toothpillow. Sure, it is just one tool in a vast toolbox to treat my children’s oral dysfunction, but it is something that will meet me where I’m at.

I am not a Toothpillow affiliate. I’m simply sharing my research, because so many parents messaged me they were in the same boat as me and my family. I was also intrigued by the varied reviews I received and wanted to dig deeper.

Other DIY Options

Just like our home project analogy, there are other options when it comes to moving your child in the right direction for oral care. Will it 100% cure them of oral dysfunction? No. However, they may be helpful tools as you research the best path for your child. I am not an affiliate for any of the below options.

MyoMunchee

The Informed Parent’s Guide to Oral Health: Navigating Your Child’s Dental Journey with Confidence and Care – An incredible ebook that discusses signs of oral dysfunction, essentials of myofunctional therapy, tonsil/adenoid concerns, tethered oral issues (tots), optimal nutrition for oral health, and tackling common dental issues in kids. I appreciated the breakdown of Myofunctional Therapy Providers, the basic myo exercises, and the varied directories for finding providers near me.

GOPex: Good Oral Posture Exercises – This book is out of print, however the author will send you a free ebook download if you sign up for his email list.

What is informed consent?