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. You should be aware of the benefits, inconveniences and risks related to using aligners. Please be advised that you and your registered 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 registered 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.

This Informed Consent outlines the risks and benefits clear aligner therapy. By clicking “accept,” you agree that you:

• Have read this Informed Consent in its entirety, and only after reading this Informed Consent and discussing any questions about clear aligner therapy with the dental professional will you be assessed for eligibility;
• Understand that you do not have to proceed clear aligner therapy treatment even if you are deemed eligible for it;
• Had the opportunity to discuss any questions you may have about SmileDirectClub clear aligner therapy with the dental professional in the SmileShop; and
• Understand that you always have the opportunity to ask your SmileDirectClub treating dentist or orthodontist any questions you may have about clear aligner therapy in the future.

 

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.
• MEDICAL TREATMENT – The aligners, through the therapeutic effect on alignment of the teeth, may treat localized bite issues, which can impact an individual’s maxillofacial health.

 

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 see a dentist for preventative check-ups at least every six months. 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 – Tooth movement may accelerate nerve damage or nerve death, resulting in a root canal, other dental treatment, or loss of the tooth. It is not possible to predict which patients may experience nerve damage, but patients who have experienced tooth injury in the past or had restoration work on a tooth are at higher risk. If your regular dentist detects nerve damage prior or during your 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 one year, 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.

 

Healthy Teeth & Gums

 

SmileDirectClub aligners are most effective if your teeth and gums are healthy. It is your responsibility to see a dentist within 6 months prior to starting SmileDirectClub aligners, to verify that your teeth and gums 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.

 

AGREEMENT TO ARBITRATE

 

AGREEMENT TO ARBITRATE – To the maximum extent permitted by applicable law, I hereby agree that any dispute regarding the products and services offered through SmileDirectClub and/or by my affiliated dental professionals, including but not limited to medical malpractice disputes, will be resolved through final and binding arbitration before a neutral arbitrator and not by lawsuit filed in any court, except claims within the jurisdiction of Small Claims Court. I understand that I am waiving any right I might otherwise have to a trial by a jury. I understand that to initiate the arbitration, I must send a Demand for Arbitration via U.S. Mail, postage prepaid to: Office of the General Counsel, SmileDirectClub, LLC, Bank of America Plaza, 414 Union Str., 8th Floor, Nashville, Tennessee 37219. The Demand for Arbitration must be in writing to all parties, identify each defendant, describe the claim against each party, state the amount of damages sought, and include the names of the patient and his/her attorney. I agree that the arbitration shall be conducted by a single, neutral arbitrator selected by the parties and shall be resolved using the rules of the American Arbitration Association.

 

I further agree that any arbitration under this agreement 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 a class action.

 

British Users

 

 

If you live in the UK, the parties will endeavor to minimize the need for long distance travel through the use of telephonic communications and will agree on a reasonable location, in the event the United States is an inappropriate forum for arbitration or court proceedings.

 

 

In the event the foregoing provision is not appropriate if you live in the UK, you agree to follow the following process: Arbitration will be pursued by the parties before the parties go to court and such arbitration will be conducted by a single arbitrator under the rules of arbitration of the Arbitration Rules of the International Chamber of Commerce (and, appreciating the location of SmileDirectClub, you acknowledge and agree that we may, in partaking in such arbitration, elect to use telephonic communications to minimize the need for long distance travel). If the parties are not able to decide on an arbitrator, the International Chamber of Commerce will decide the arbitrator. Notwithstanding the foregoing, either party may pursue the protection of intellectual property rights and confidential information and to stop other illegal activities through injunctive relief or other equitable relief through the courts. By using the Services, you agree that English law will govern these terms and any dispute related to the Service that might arise between You and Us. If you live in the UK and court action is initiated, the parties will agree on a reasonable location via which the dispute will be heard, including using telephonic communications to minimise the need for long distance travel. This section will survive termination of your relationship with SmileDirectClub.

 

 

Informed Consent

 

TELEHEALTH – I hereby consent to use SmileDirectClub’s teledentistry platform so a registered dentist and I can engage in telehealth as part of my clear 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 registered dental professional who has engaged SmileDirectClub to provide certain non-clinical dental support organisation services.

 

By signing this Informed Consent, I understand that I am certifying that: My dentist has cleaned my teeth and has checked for and repaired cavities, loose or defective fillings, crowns or bridges. 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 in the last 6 months 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 certify that I can read and understand English, and that if I cannot read and understand English, that I notified SmileDirectClub so that language assistance could be provided to me so that I understand this History & Consent. I acknowledge that neither the dentist prescribing my aligner therapy treatment nor SmileDirectClub has made any guarantee or assurance to me. I have read this form and fully understand the benefits and risks listed in this form related to my use of SmileDirectClub clear aligners. I understand that SmileDirectClub contracts with professional corporations which have engaged registered dentists and orthodontists. 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 neither the dentist who prescribed my aligner therapy treatment nor SmileDirectClub can guarantee any specific result or outcome. 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. Because I am choosing not to engage the in-patient services of a local dental professional, I understand and accept that my teeth will be straighter than they currently are but may still be compromised

 

I release SmileDirectClub from liability for any claims by me or any third party in connection with my participation or use of the clear aligner therapy treatment.

 

 

Data Protection Consent

 

 

By checking the box linked to this Informed Consent & History form, I hereby consent to the processing of personal data relating to my oral and dental health, and any other relevant health information, for the purposes of receiving the aligner therapy products and services for which I have contracted with SmileDirectClub. Further information about the types of personal data and purposes for which they are processed, as well as my rights, can be found in the Privacy Policy.

 

 

I also understand that I am free to choose whether to provide my consent, and that my consent can be withdrawn at any time by contacting SmileDirectClub at CustomerCare@SmileDirectClub.co.uk. Withdrawal of my consent will not affect the lawfulness of processing previously based on consent. The effects of withdrawing consent will vary, depending on the stage at which consent is withdrawn. However, I understand that, if I withdraw my consent, SmileDirectClub may be unable to continue providing me with the contracted products and services.

 

I further understand that my dentist's processing of my health data is not contingent on this consent and will be carried out under a separate legal basis.

 

 

 

 

Last Revised: November 2021