Informed Consent to Telehealth and Teledentistry

I hereby consent to use SmileDirectClub’s teledentistry platform so a provincially-licensed dentist (i.e. my Treating Dentist) and I can engage in telehealth as part of my aligner therapy treatment. I confirm that 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 provincially-licensed dental professional who has engaged SmileDirectClub to provide certain non-clinical dental support organization services. I understand that my Treating Dentist will prescribe a personalized treatment plan and then look after my treatment remotely.

I understand that consent is an ongoing process and that I can withdraw my consent at any time by contacting the SmileDirectClub patient care team at (800) 765-8951 or support@smiledirectclub.com to get in touch with one of the SmileExperts, or to get in touch with my Treating Dentist.

I 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 and in accordance with all applicable laws.

I further consent to SmileDirectClub sharing my personal and medical information with dentists and/or dental clinics for the purposes of non-aligner therapy related dental services.

I hereby grant SmileDirectClub the right to use photographs taken of me and my first name for educational and/or marketing purposes. I acknowledge that because my participation is voluntary, I will receive no financial compensation. I also agree that my participation confers upon me no right of ownership.

To the fullest extent permitted by law, I release SmileDirectClub from liability for any claims by me or any third party in connection with my participation or use of the invisible aligner therapy treatment. I also understand that my treatment is not conditioned on my agreement to the use of my photographs or name, and that I can revoke this grant at any time by sending a written revocation to SmileDirectClub, who will then inform my Treating Dentist.

I hereby confirm that I have expressly chosen the English version of this document.  Par les présentes, je confirme avoir expressément choisi la version anglaise de ce document.

Informed Consent to Prescribed Treatment Plan

The licensed dentist or orthodontist responsible for your care throughout your clear aligner therapy (namely, your “Treating Dentist”) will prescribe a treatment plan to address your chief complaint through SmileDirectClub’s aligner therapy system, if you are deemed eligible. The name of your Treating Dentist, along with information to contact your Treating Dentist will be provided to you with your treatment plan. Throughout your clear aligner therapy, your Treating Dentist is available to ‎answer questions about clear aligner orthodontic therapy and your treatment plan - just contact our customer care team via email, chat or telephone and we will arrange for your Treating Dentist to contact you.

SmileDirectClub’s clear aligner therapy involves a series of invisible, BPA-free plastic aligners that apply subtle pressure to gradually shift your teeth. The invisible 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.

While orthodontic treatment may improve your smile, you should be aware that ‎orthodontic treatment (including treatment with SmileDirectClub aligner therapy) has limitations ‎and potential risks. The benefits, inconveniences and risks related to using clear aligners and teeth whitening products are detailed below.

If you would like to speak with a dentist before signing this consent form,‎ or to get in touch with one of our SmileExperts, please contact the SmileDirectClub patient care team at (800) 765-8951 or support@smiledirectclub.com. You can also visit our Frequently Asked Questions (https://smiledirectclub.ca/faq/), as we may have already addressed your question(s) or concern(s) on our webpage.

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

• Have read this Informed Consent to Treatment Plan in its entirety, and only after reading and signing this Informed Consent to Treatment Plan ‎will you be assessed for eligibility;
• Understand that you do not have to proceed with 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 your Treating Dentist; 
• Understand that when you receive your treatment plan as prescribed by your Treating Dentist, you will be provided with this Informed Consent to Treatment Plan and will review it in its entirety and raise any additional questions you may have about SmileDirectClub clear aligner therapy with your Treating Dentist at that time; and
• Understand that you always have the opportunity to ask your SmileDirectClub Treating Dentist any questions you may have about clear aligner therapy in the future.

INFORMED CONSENT TO ALIGNER THERAPY ORTHODONTIC TREATMENT AND ALTERNATIVE COURSE(S) OF ACTION

SmileDirectClub aligner therapy is indicated for the treatment of tooth malocclusion (e.g. alignment and crowding issues). However, aligners are not intended to provide a full orthodontic correction including a correction of your existing bite condition, etc. You may wish to seek advice from your local dental professional (e.g. your regular dentist) on alternative courses of action.

Please be advised that you and your Treating 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. Should your Treating Dentist determine that your chief complaint cannot be addressed using the SmileDirectClub aligner therapy, you may wish to seek advice from your local dental professional (e.g. your regular dentist) on alternative courses of action.

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.

BENEFITS, RISKS, AND SIDE EFFECTS

Further to review of your file,‎ your aligner therapy Treating Dentist has asked us to let you know the following benefits, risks, and side effects:

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 colour of your teeth by removing stains.

Aligner Risks and Side Effects

• 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, as well as the SmileDirectClub patient care team so that we can 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 your local dental professional (e.g. your regular dentist) or another 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 local dental professional (e.g. 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 local dental professional (e.g. 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 local dental professional (e.g. 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 with 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 Treating Dentist.
• 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 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 invisible 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 inherit 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, for example associated with additional impressions or intra-oral scans and/or refinement aligners. 

Difficult cases may require IPR (interproximal reduction) and/or extractions with traditional braces for ideal results, which are services beyond the scope of SmileDirectClub’s aligner therapy. If desired, your Treating Dentist can refer you to another dentist or orthodontist to discuss these options with you, as necessary. 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.

Whitening Risks

• TYPE OF DISCOLOURATION – 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 see a dentist within 6 months 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.

CONSEQUENCES OF NOT HAVING TREATMENT

Please be advised that the SmileDirectClub aligner therapy and teeth whitening systems are elective treatments. As such, there are no overt consequences of not having the SmileDirectClub aligner therapy and teeth whitening systems treatments. Rather, the consequences of not having the SmileDirectClub aligner therapy and teeth whitening systems treatments are merely continuing with your pre-existing state of dental health.

INFORMED CONSENT

I understand that consent is an ongoing process and that I can withdraw my consent at any time by contacting the SmileDirectClub patient care team at (800) 765-8951 or support@smiledirectclub.com to get in touch with one of your SmileExperts, or to get in touch with my Treating Dentist.

I acknowledge that neither the Treating 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 aligners and whitening system.

I have had an opportunity to discuss and ask any questions about aligner therapy treatment with a provincially-licensed dentist who engaged SmileDirectClub to facilitate my treatment. I understand that neither the Treating Dentist who prescribed my aligner therapy treatment nor SmileDirectClub can guarantee any specific result or outcome. I further understand that my invisible aligner therapy treatment will only address the alignment of my ‎teeth and will not provide a full orthodontic correction including a correction of my existing bite ‎condition. I understand that I will need to seek more comprehensive treatment via my local dental ‎professional for a full orthodontic correction as well as to correct my existing bite condition. I further ‎understand that I will need to address any common side effects of orthodontic treatment such as ‎rectifying and managing black triangles and bite adjustments with my local dental professional.  ‎Because I am choosing not to engage the in-patient services of a local dental professional for my ‎SmileDirectClub aligner therapy, I understand and accept that my teeth will be straighter than they ‎currently are but may still be compromised.

I hereby confirm that I have expressly chosen the English version of this document.  Par les présentes, je confirme avoir expressément choisi la version anglaise de ce document.