Consent and History

How Does the SmileDirectClub Aligner Therapy System Work?
 

SmileDirectClub's aligner therapy system is a series of clear, BPA-free plastic aligners that apply subtle pressure to gradually shift your teeth. The clear aligners are made to be worn in a specific sequence prescribed by your treating dentist. Each new aligner will gradually shift teeth. While every case is unique to each patient, the process typically takes approximately 4 to 8 months to complete. During treatment, an optional teeth whitening system may be used. You should be aware of the benefits, inconveniences and risks related to using aligners and teeth whitening products. Please be advised that you and your dentist may not be able to achieve all aspects of your chief complaint. This is due to factors beyond anyone’s control, including the guidelines and parameters that must be followed with remote clear aligner therapy. If, with your chief complaint in mind, your treating dentist determines you are a candidate for treatment using the SmileDirectClub aligner therapy system - and you follow your treating dentist’s instructions - you will receive the best possible outcome available using the SmileDirectClub clear aligner therapy treatment. Feel free to contact the SmileDirectClub patient care team to discuss any concerns you may have or to get in touch with your treating dentist.

Your aligner therapy treating dentist has asked us to let you know the following:

Aligner Benefits

• DISCREET – The aligners are made of clear, BPA-free plastic. The trays are thin, light weight and nearly invisible when worn - many people won't even know you're wearing them.
• HYGIENE – Because the aligners can be removed, you can eat, brush and floss normally, and the process of using aligners may improve your oral hygiene habits.

Whitening Benefits

• WHITE TEETH – The whitening system may lighten the color of your teeth by removing stains.

Aligner Risks

• DISCOMFORT – Your mouth is sensitive, so you can expect an adjustment period and some minor discomfort from moving your teeth. You may also experience gum, cheek or lip irritation when you initially use an aligner while these tissues adjust to contact with the aligner trays.
• ALLERGIC REACTION – It is possible for some patients to become allergic to the materials used to create your aligners. If you experience a reaction, please immediately discontinue use and inform your primary care provider and us so that we may advise your treating dentist.
• TEMPORARY SIDE EFFECTS – You may experience temporary changes in your speech or salivary flow while using aligners because of the presence of the aligner tray in your mouth.
• CAVITIES, GUM OR PERIODONTAL DISEASE – Cavities, tooth decay, periodontal disease, gingival recession, inflammation of the gums or permanent markings (e.g. decalcification) may occur or accelerate during use of aligners. These reactions are more likely to occur if you eat or drink lots of sugary foods or beverages, or do not brush and floss your teeth before inserting the aligners, or do not routinely see a dentist for preventive check-ups. In addition, in some circumstances discoloration or white spots may occur; small cavities may increase in size, causing sensitivity and, in some cases, pain or tooth breakage; gingival inflammation may increase, causing soreness and/or bleeding. If underlying periodontal conditions persist unchecked, they may become more prevalent and lead to tooth loss. You may have to discontinue aligner treatment. All of these symptoms will require you to seek care from a dentist of your choice.
• SHORTENING OF THE ROOTS/RESORPTION – The roots of some patients' teeth become shorter (resorption) during use of aligners. It is not possible to predict which patients will experience it, but patients who have had braces in the past are at higher risk. Resorption can impact the long-term health of teeth. If resorption is detected by your regular dentist during orthodontic treatment, treatment may need to be discontinued or tooth loss may occur. If a primary (or "baby") tooth is present, any orthodontic movement would accelerate the resorption process, leading to its loss.
• NERVE DAMAGE IN TEETH – An injured tooth can die over a period of time with or without clear aligner therapy treatment and it may not be obvious that a tooth was previously injured. Nerve damage to an injured tooth may flare up from movement during clear aligner therapy and may require root canal treatment. While this seldomly occurs during clear aligner treatment, if and when it does it is most frequently related to a previous accident or injury. It is not possible to predict which patients may experience nerve damage during clear aligner therapy treatment, but patients who have experienced tooth injury in the past or have restorative work on a tooth are at higher risk. If your regular dentist detects nerve damage prior to or during your clear aligner therapy treatment, treatment may need to be discontinued or tooth loss can occur.
• TEMPOROMANDIBULAR JOINT DYSFUNCTION (TMJ) – Problems may occur in the jaw joints during aligner therapy treatment, causing pain, headaches or ear problems. The following factors can contribute to this outcome: past trauma or injury, arthritis, hereditary history, tooth grinding or clenching and some medical conditions. In the event that you experience any of these symptoms, please see your regular dentist.
• IMPACTED AND SUPERNUMERARY TEETH – Teeth may become impacted or trapped below the bone or gums. Sometimes some patients are born with "extra" or supplementary teeth. If you have impacted, un–erupted or supplementary teeth, aligners are not an ideal option.
• SUPRAERUPTION – If a tooth is not properly covered by an aligner, it may migrate outwards (supraeruption) leading to difficulty cleaning, gum disease, tooth decay and loss of tooth.
• PREVIOUS DENTAL TREATMENT – Aligners will not move implants and may not be effective on some dental restorations, such as bridges. Additionally, dental restorations, such as crowns, veneers, or bridges, may require replacement due to tooth movement.
• PARTIAL OR FULL DENTURES – If you decide to move forward with orthodontic clear aligner therapy with the presence of a partial or full denture you may need to replace the partial or full denture after you complete your orthodontic clear aligner therapy as it may no longer fit due to tooth movements or changes in your bite. Any necessary replacements will be at your own expense and is not be part of the orthodontic clear aligner therapy provided by your SmileDirectClub affiliated doctor.
• ORAL PIERCINGS – Piercings are contraindicated during aligner therapy and therefore should be removed during treatment. In some circumstances, failure to do so could result in fractures to the aligners or broken teeth leading to termination of aligner therapy treatment.
• BONDED RETAINER – Bonded retainers, attachments and buttons are contraindications during aligner therapy and should be removed prior to aligner therapy treatment. Should you choose to proceed with aligner therapy treatment, you must first have your bonded retainers, attachments or buttons digitally removed for purposes of creating your treatment plan and expect to treat the arch on which they are placed at the time of your imaging. Further, you agree that you are responsible for having such bonded retainers, attachments or buttons removed by your regular dentist before beginning aligner therapy treatment. You are also responsible for consulting with your regular dentist regarding the potential consequences of their removal and obtaining, at your expense, all dental care required for their removal. By signing the consent below, you are thereby confirming that you are aware that clear aligners cannot move your teeth effectively with these devices in place and that they must be removed prior to commencing your aligner therapy treatment with the SmileDirectClub aligners.
• OTHER RISKS – Orthodontic treatment and the movement of teeth bring inherent and potential risks and side effects. In the case of aligner therapy, such risks include, but are not limited to, discomfort, swelling, sensitivity, numbness, sore jaw muscles, allergic reaction to dental materials, and unforeseen conditions that may be revealed during treatment which may necessitate extension of the original procedures or the recommendation of other patient–specific procedures. Additionally, the tissue attachment between the front teeth may become inflamed, which is a common result of aligner therapy. The procedure required to treat this, known as a frenectomy, is not a part of your prescribed aligner therapy treatment, but is a recommended adjunctive treatment for the best outcome and long-term stability of your smile.
• SAFETY – Aligners may break, be swallowed or inhaled. You may also have an allergic reaction to the materials used in the aligners.
• GENERAL HEALTH PROBLEMS – Overall medical conditions such as bone, blood or hormonal disorders, and many prescription and non-prescription drugs (including bisphosphonates) can affect the movement of the teeth and the outcome.
• DURATION AND RESULT – The length of time you wear the aligners and the results depend on many factors, including, but not limited to: the severity of your case, the shape of your teeth, or the amount of time you wear the aligners per day. The average person generally wears the aligners for 4 – 8 months, but your particular rate of tooth movement is impossible to predict and could take longer. If the duration is extended beyond the original estimate, additional fees may be assessed. Difficult cases may require IPR and/or extractions with traditional braces for ideal results. Please note that the related additional costs will be your responsibility.
• RETAINERS – Teeth may move again after you stop wearing the aligners. Retainers will be required to keep your teeth in their new positions for a lifetime. Your retainer should be worn full-time for 2 weeks and then nightly from then on. You can expect a retainer to last about 6 months, but this can vary greatly from patient to patient.
• BITE ADJUSTMENT – Your bite may change during treatment and may result in temporary discomfort. Your bite may require adjustment after use of the aligners.
• BLACK TRIANGLES – Teeth which have been overlapped for long periods of time may be missing the gum tissue and when these teeth are aligned, a "black triangle" appears below the interproximal contact.

Whitening Risks

• TYPE OF DISCOLORATION – The whitening system will not lighten all teeth or restorations in teeth. Blue, gray, multi–colored, or striped discoloration may not respond to whitening. If you have gum recession or periodontal disease, the area of the tooth near the gum line may not respond to the whitening. Similarly, fillings, cavities or other damage will not lighten. Use of cigarettes, wine, coffee, tea, and similar stain producing agents will also slow whitening process.
• WHITE/TOOTH COLORED FILLINGS – White or tooth colored fillings will not lighten or may become softer after using the whitening system. These fillings may need to be replaced after whitening to match lighter teeth or if they become soft. Please note that the related additional costs will be your responsibility.
• SENSITIVITY AND IRRITATION – Gum irritation may arise from excessive use of whitening system, as might throat irritation if whitening agent is swallowed. Tooth sensitivity may occur during initial use. In addition, discomfort and possible permanent nerve damage can arise if whitening agent leaks into damaged or cracked teeth fillings.
• REVERSIBLE – Whitened teeth can darken again over time. Reduction of certain types of foods and beverages will reduce staining of teeth.

Healthy Teeth & Gums

SmileDirectClub aligners are most effective if your teeth and gums are healthy. It is your responsibility to routinely see a dentist prior to starting SmileDirectClub aligners, to verify that your teeth and gums are healthy prior to using SmileDirectClub aligners. It is also your responsibility to maintain and have follow-up dental care during and after SmileDirectClub aligner therapy.

BINDING ARBITRATION & CLASS ACTION WAIVER AGREEMENT

I agree that any and all disputes, claims or controversies directly or indirectly arising out of or relating to this Agreement or any aspect of the relationship between me, on the one hand, and SmileDirectClub, Inc., SmileDirectClub, LLC, or their parents, subsidiaries, related entities, or affiliates, or affiliated dental professionals (collectively “SDC”), on the other hand, whether based in contract, tort, statute, fraud, misrepresentation or any other legal theory – including, but not limited to, claims relating to my account, SDC products and services, communications from or on behalf of SDC, and medical malpractice disputes (“Disputes”) – shall be submitted to JAMS, or its successor, for confidential, final and binding arbitration to be resolved by a single arbitrator. I further agree that the arbitration will take place on an individual basis, that class arbitrations and class actions are not permitted, and that I am agreeing to give up the ability to participate in any class action. For avoidance of doubt, I am agreeing to give up the ability to bring a lawsuit in court (except small claims discussed below); and I am giving up the ability bring or participate in a class action in any form or forum, even if my Dispute is determined not to be subject to arbitration.

I agree that I will send notice of my Dispute to the mailing address below, and that I must wait 30 days after notice is received by SDC to initiate arbitration. If I initiate arbitration, I will do so in accordance with JAMS Streamlined Rules for Arbitration (“Rules”). The JAMS arbitrator shall resolve the Dispute and is empowered with the exclusive authority to resolve any dispute relating to the interpretation, applicability or enforceability of these terms or the formation of this Agreement, including the arbitrability of any dispute and any contention that all or any part of this Agreement is unconscionable, void or voidable. Any arbitration conducted pursuant to the terms of this Agreement shall be governed by the Federal Arbitration Act (9 U.S.C.§§ 1–16). The party that prevails in the arbitration shall be entitled to recover from the other party all reasonable attorneys’ fees, costs and expenses incurred by the prevailing party in connection with the arbitration; except that this provision shall not apply if I live in California.

The arbitration will be administered by JAMS under its Rules and will comply with the JAMS Consumer Minimum Standards (which are incorporated by reference). Notwithstanding the foregoing, I understand that I may instead litigate a Dispute in small claims court if the Dispute meets the requirements to be heard in small claims court.

I UNDERSTAND THAT I AM WAIVING ANY RIGHT I MIGHT OTHERWISE HAVE TO A TRIAL BEFORE A JUDGE OR JURY. I understand that upon initiating the arbitration in accordance with JAMS rules, I must send a copy of the Demand for Arbitration via U.S. Mail to SmileDirectClub, Inc., Attn: Legal Dept., Phillips Plaza, 414 Union Str., 8th Floor, Nashville, Tennessee 37219.

I understand and agree that SDC may, from time to time, amend this Agreement at its sole discretion, to the fullest extent permitted by law, by providing notice of the amendment to the email address that SDC has for me on file. I understand that any amendments to the Agreement will become effective 30 days after notice is provided by SDC and shall not apply to any Disputes that have accrued before the date of the amendment.

The formation, existence, construction, performance, and validity of this agreement shall be governed by the laws of the State of Tennessee and the United States, without reference to choice or conflict of law principles.

Informed Consent

TELEHEALTH – I hereby consent to use SmileDirectClub’s teledentistry platform so a state-licensed dentist and I can engage in telehealth as part of my aligner therapy treatment. I understand that "telehealth" includes the practice of health or dental care delivery, diagnosis, consultation, treatment, and transfer of medical/dental information, both orally and visually, between me and a state licensed dental professional who has engaged SmileDirectClub to provide certain non-clinical dental support organization services.

By signing this Informed Consent, I understand that I am certifying that: During my most recent visit, my dentist has cleaned my teeth and has checked for and repaired cavities, loose or defective fillings, crowns or bridges. My dentist assessed me for dental nerve damage. My dentist checked my last x-rays or has otherwise verified that I have no shortened or resorbed roots or impacted teeth. My dentist has probed or measured my gum pockets and confirmed that I do not have periodontal or gum disease. My dentist performed a full oral-cancer screening and confirmed that I do not have oral cancer. I confirm that I do not have pain in any of my teeth or jaws. I further confirm that none of my teeth are loose, that I do not have any “baby teeth” and that all of my permanent teeth are present. I further consent to SmileDirectClub sharing my personal and medical information with third parties, business associates, or affiliates for the purposes of aligner therapy treatment planning and/or manufacturing purposes.

I certify that I can read and understand English. I have read this form and fully understand the benefits and risks listed in this form related to my use of SmileDirectClub aligners and whitening system. I understand that SmileDirectClub contracts with professional corporations which have engaged licensed dentists and orthodontists in the state in which I reside. I hereby provide my consent for one or more of the dentists or orthodontists affiliated with that professional corporation to review my records for potential evaluation, diagnosis, and treatment. I understand that my acceptance of the treatment plan approved by my treating dentist and presented to me prior to the onset of treatment reflects the results I expect to achieve through clear aligner therapy. I understand that my treatment plan may have to be modified and as a result, I may have to undergo adjustments (“touch-ups”) during my clear aligner therapy to achieve results agreed to in my original treatment plan. I also understand that neither the dentist who prescribes my clear aligner therapy treatment nor SmileDirectClub can, with certainty, predict the events that may lead to touch-ups. I further understand that my clear aligner therapy treatment will only address localized bite issues and will not specifically treat Angle’s orthodontic classifications II and III of malocclusion. In order to correct Angle’s orthodontic classifications II and III of malocclusion directly, I will need to seek more comprehensive treatment via my local dental professional. I understand that the dentist who prescribes my aligners will determine the best course of treatment for me and that I may be prescribed 22-hour clear aligners even if I prefer Nighttime Clear Aligners. Lastly, I understand that for aligner therapy to achieve results agreed to in my treatment plan, I must be compliant with the treating dentist’s prescribing instructions, including those that are required via touch-ups, if applicable.

I hereby authorize SmileDirectClub’s use of photographs taken of me, including certain personal health information such as my first name and likeness, for educational and/or marketing purposes, which may result in disclosure to the general public. I acknowledge this authorization is voluntary, I will receive no financial compensation, and my participation in clear aligner treatment does not confer upon me any right of ownership in such photographs. I hereby release SmileDirectClub from any and all liability for any copyright, trademark, or other intellectual property-related claims by me or any third party in connection with my clear aligner treatment. I also understand (i) my treatment is not conditioned on my authorization of SmileDirectClub’s use of my name or likeness, (ii) I have the right to access, inspect, and receive a copy of any such photograph used by SmileDirectClub, and (iii) I can refuse to provide or otherwise revoke such authorization by contacting SmileDirectClub at CustomerCare@smiledirectclub.com. This authorization is valid in perpetuity from the date of my consent hereto, unless earlier revoked in the manner prescribed above.

In the event that the SmileDirectClub affiliated doctor who reviews my chart and other information that I submit determines that I am not an appropriate candidate for the SmileDirectClub aligner therapy treatment, but that I am a candidate for more advanced orthodontic treatment, I hereby consent to having all of my records in SmileDirectClub's possession (including without limitation dental impressions, digital scans, photographs, and medical history documentation) sent to a licensed dentist or orthodontist for further review and treatment planning, and I agree to being contacted directly by that dental or orthodontic provider.