Patient Consent
(Updated June 2023)
How Smiles Club Helps You
Smiles Club’s program makes it easy to have a beautiful smile, without the hassle of surgery or braces. Smiles Club provides a series of clear, plastic aligners which gently apply pressure to your teeth. Through this process, the series of aligners carefully guides your teeth into a more beautiful smile. Our orthodontists and dental software techs design your aligners for each stage of the straightening process, which typically lasts between 3 to 18 months depending on the complexity of your case and the comfort you desire in the process. The information below provides you information to assist in your decision whether or not to use Smiles Club’ straightening products, including the lasting benefits, potential difficulties and risks associated with this process, which you should discuss with a dentist. If you have questions or concerns, you should always feel free to contact the Smiles Club’ patient care team. We are here to help you meet your goals.
Benefits
Smiles Club offers a clear aligner made from a premium aligner material. Unlike traditional braces, Smiles Club’s aligner trays are unlikely to gain attention due to their clear, thin, and light weight structure. The removable aligners allow you to eat, brush, and floss normally, and without the undesirable side effects of braces.
Risks
Smiles Club’ clear aligners are not appropriate for all patients and may pose certain risks. Although rare, you may experience possible:
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 discontinue use, and inform us and your primary care doctor immediately.
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 inter-proximal contact.
Cavities, Gum, or Periodontal Disease - Cavities, tooth decay, periodontal disease, 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 leading 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.
Damage to Nerves 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 or had restoration work on a tooth are at higher risk. If your family dentist detects nerve damage prior or during your aligner treatment, treatment may need to be discontinued or eventual tooth loss could occur.
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. Further, your bite may change during treatment and may result in temporary discomfort. Your bite may require adjustment after use of the aligners.
General Health Issues - Overall medical conditions such as bone, blood or hormonal disorders, and many prescriptions and non – prescription drugs (including bisphosphonates) can affect the movement of the teeth and the outcome.
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, unerupted or supplementary teeth, aligners may not be an ideal option. If you have impacted teeth you may go through the digital scanning or impression kit process to determine if Smiles Club is right for you.
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 fractured aligners or broken teeth leading to termination of aligner treatment.
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.
Safety - Aligners may break, be swallowed, or inhaled. You may also have an allergic reaction to the materials used in the aligners.
Shortening or Root/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 family dentist during orthodontic treatment, treatment may need to be discontinued or eventful tooth loss could occur. If a primary (or “baby”) tooth is present, any orthodontic movement would accelerate the resorption process leading to its loss.
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.
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.
Temporomandibular Joint Dysfunction (TMJ) - Problems may occur in the jaw joints during aligner therapy 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.
Do Not Use the product if you have the following conditions:
- Severe open bites, severe overjet, severe overbite, tooth malocclusion requiring surgical correction, mixed dentition (both infant and adult teeth), dental prosthetics or dental implants, active periodontal disease, active tooth decay or dental caries, permanent retainers, mental illness or PETG material allergy.
- A Warning: In rare instances, some people may be allergic to the aligner material or other included materials. If you happen to be one of them, stop using immediately and contact a health care professional immediately. Orthodontic appliances can be accidentally swallowed or aspirated and may be harmful.
- Smiles Club’ clear aligners are suitable for non-bone Malocclusion deformity correction. When in doubt, play it safe. Call your medical professional if you’re experiencing any adverse effects and get in touch anytime at support@Smiles.club.
- Smiles Club clear aligner therapy should not be used by people with active periodontal disease.
- If you have any medical conditions listed here or otherwise which you believe will interfere with your use of Smiles Club products, please consult with your physician before proceeding.
Other Risks and Warnings
Smiles Club's Aligner Program is not intended as a replacement to regular dental examinations and dental care. 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 Smiles Club treatment, but is a recommended adjunctive treatment for the best outcome and long-term stability of your smile.
Duration and Results
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 3 – 18 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.
You acknowledge that your treatment results may not be the same as the simulation shown in the treatment plan videos. You also acknowledge that Smiles Club does not guarantee that your teeth will move following the video simulation. To finetune results’ discrepancies, your treatment plan includes a refinement plan with up to 4 extra aligners. A new impression kit and extra aligners are not included.
Do not throw away your aligners at any point until your treatment is 100% complete and you have retainers. If at any point during treatment you are asked to go back to a previous aligner, for example if you lose an aligner, we need for you to have all of your previous aligners available.
Future 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 no more than one year, but this can vary greatly from patient to patient. Due to wear and tear we recommend buying new retainers at least once every six months.
Alternatives
Alternatives to Smiles Club's Aligner Program include traditional braces, surgical options, and living with your teeth as they are.
Informed Consent
I accept this Informed Consent, by purchasing a product, and I understand that I am certifying that:
- My dentist cleaned my teeth.
- My dentist took x-rays of my teeth.
- My dentist checked for and repaired cavities, loose or defective fillings, crowns, or bridges.
- My dentist checked my x-rays and I have no shortened or resorbed roots.
- My dentist checked my x-rays and I have no impacted teeth.
- My dentist has proved or measured my gum pockets and says I do not have periodontal or gum disease.
- My dentist performed a full oral-cancer screening in the last 6 months, and I do not have oral cancer.
- I have no pain in any of my teeth.
- I have no pain in my jaws.
- I have no loose teeth.
- I have no “baby teeth” and all my permanent teeth are present.
I also agree that, in the event that a Smiles Club Dental Professional who is overseeing my aligner treatment determines that additional observation by my personal dentist is required to proceed, that I will make an appointment and re-certify an attestation addressing the identified concern within 30 days of my receipt of the concern from a dentist.
Pregnancy - For women who are or may become pregnant: I agree that, although I may start or continue treatment during pregnancy, in order to do so, I will receive authorization from my treating physician prior to starting or continuing aligner treatment. While I do not have to provide this authorization to Smiles Club, by agreeing to this section, I agree that it is my obligation to communicate with my doctor prior to starting or continuing the aligner process during pregnancy.
I certify that I can read and understand English. Or that I have had an accurate translation of all of the materials informing me about the Aligner Program. I understand the risks, benefits, and alternatives described above in deciding to enter into an agreement to participate in Smiles Club’s Aligner Program. I understand that, in addition to discussing the information contained in this form with a dentist, and giving my consent, by purchasing a product, I may be required to provide oral consent or other forms of consent consistent with my local state laws. I hereby voluntarily consent to engage in the Smiles Club Aligner Program, as part of my clear aligner treatment program, after having been advised of the risks and disadvantages of the treatment. I understand that the Aligner Program includes the provision of health or dental care evaluation, diagnosis, consultation, treatment, electronic and/or oral transfer of dental information or photographs and, if necessary medical information, to a participating licensed dental professional within my state. I understand that in order for this process to proceed, Smiles Club will share my personal and medical information with third parties, business associates, or other persons for the purposes of diagnosis, aligner and treatment plans and for product manufacturing and I hereby consent to the sharing of this information with such parties. Neither Smiles Club nor any affiliate has made any guarantees or assurances to me. I understand no specific results or outcomes are guaranteed. Prior to accepting this Informed Consent, by purchasing a product, I discussed Smiles Club’ Aligner Program with a dentist and was afforded the opportunity to ask questions about the use of clear aligners and Smiles Club’s Aligner Program. By purchasing a product, I agree that my questions have been answered to my satisfaction. I further understand that while Smiles Club clear aligner treatment will not correct any existing bite condition. I understand I will need to seek dental advice from a separate dental professional if I desire to correct any bite condition, because, although my teeth will be straighter, any preexisting bite condition will remain compromised after my Smiles Club participation in Smiles Club’s Aligner Program.
Exchanges and Returns
If you receive a product that is damaged let us know by sending an email to
support@Smiles.club and we will replace it.
For your safety, we do not accept returns. Most products ship the same day they are ordered, or in the case of custom aligners we begin production of your custom aligners as soon as you complete your aligner purchase. Once an order has been placed, we cannot accept exchanges or returns.
Disputed or Past Due Accounts
Disputed or past due accounts may result in delayed or discontinued treatment.
Video/Photograph Release
I hereby grant Sonrisas, LLC (hereby “Smiles Club”) the irrevocable right and permission to use photographs and/or video recordings of me to use and disclose information about me for the purposes of creating photographs or video clips, as well as stand-alone pictures/graphics in which I may appear and/or be heard, for use in internal Smiles Club publications and for the purpose of training of Smiles Club employees. Smiles Club’s use of any photographs or video recordings will be limited to internal websites and publications. Smiles Club agrees that any photographs or video clips will not be used on social media or any public media platforms. The purpose of these recordings is for training purposes and for internal use only.
I understand and agree that such photographs and/or video recordings of me may be placed on the internal Smiles Club websites. I also understand and agree that I may be identified by name and/or title in such internal printed, website, or broadcast information that might accompany the photographs and/or video recordings of me. I waive the right to approve the final product. I agree that all such portraits, pictures, photographs, video and audio recordings, and any reproductions thereof, and all plates, negatives, recording tape and digital files are and shall remain the property of Smiles Club.
I hereby release, acquit and forever discharge Smiles Club, its current and former directors, agents, officers and employees of the above-named entity, its affiliates or assigns, from any and all claims, demands, rights, promises, damages, and liabilities arising out of or in connection with the use or distribution of said photographs and/or video recordings, including but not limited to any claims for invasion of privacy, appropriation of likeness or defamation.
I hereby warrant that I am eighteen (18) years old or more and competent to contract my own name or, if I am less than eighteen years old, that my parent or guardian accepting this Informed Consent, by purchasing a product. This release is binding on me and my heirs, assigns and personal representatives.
AGREEMENT TO ARBITRATE AND CLASS ACTION WAIVER
READ THIS SECTION CAREFULLY BECAUSE IT REQUIRES THE PARTIES TO ARBITRATE THEIR DISPUTES AND LIMITS THE MANNER IN WHICH YOU CAN SEEK RELIEF FROM SONRISAS, LLC.
By agreeing to the Patient Consent, you agree with and have taken time to consider the terms of Sonrisas, LLC (hereby “Smiles Club”) and the consequences thereof, to arbitrate and waive any class action lawsuit. You agree that you are required to resolve any claim that you may have against Smiles Club, or any of their affiliated dental professionals, including but not limited to medical malpractice disputes, as set forth in this Arbitration Agreement. This will preclude you from bringing any class, collective, or representative action against Smiles Club and will also preclude you from participating in or recovering relief under any current or future class, collective, consolidated, or representative action brought against Smiles Club by someone else.
Release and Limitations of Liability
You hereby agree that you will release and hold harmless your referring insurance company and/or referring agent, broker, agency, or company from and against any claim, injury, demand, judgment, or cause of action, arising from any acts, omissions or dissatisfaction associated with Smiles Club.
You therefore waive the right to claim any damages whatsoever from your referring insurance company and/or referring agent, broker, agency, or company, from any claims and causes of action arising out of, or connected with Smiles Club, including, but not limited to, punitive, consequential, direct, or indirect damages.
Agreement to Binding Arbitration Between You and Smiles Club.
You and Sonrisas, LLC (hereby “Smiles Club”) agree to arbitrate any and all Disputes arising out of or related to this agreement or any aspect of the relationship between you and Smiles Club. Arbitration is more informal than a lawsuit in court and seeks to resolve disputes more quickly. Instead of a judge or a jury, the case will be decided by a neutral arbitrator who has the power to award the same damages and relief that a court can.
THIS ARBITRATION CLAUSE INCLUDES ALL DISPUTES ARISING OUT OF OR RELATED TO THIS AGREEMENT OR ANY ASPECT OF THE RELATIONSHIP BETWEEN YOU, ON THE ONE HAND, AND SMILES CLUB OR ITS CONTRACTORS, PERSONNEL, DIRECTORS, AFFILIATES OR SUPPLIERS, ON THE OTHER HAND, WHETHER BASED IN CONTRACT, TORT, STATUTE, FRAUD, MISREPRESENTATION OR ANY OTHER LEGAL THEORY, THAT IT WILL BE RESOLVED THROUGH FINAL AND BINDING ARBITRATION BEFORE A NEUTRAL ARBITRATOR INSTEAD OF IN A COURT BY A JUDGE OR JURY AND YOU AGREE THAT YOU ARE WAIVING THE RIGHT TO TRIAL BY A JURY. YOU AGREE THAT ANY ARBITRATION UNDER THIS AGREEMENT WILL BE ONLY ON AN INDIVIDUAL BASIS; CLASS ARBITRATIONS, CLASS ACTIONS, PRIVATE ATTORNEY GENERAL ACTIONS, AND CONSOLIDATION WITH OTHER ARBITRATIONS ARE NOT PERMITTED, AND YOU ARE WAIVING YOUR RIGHTS TO HAVE YOUR CASE DECIDED BY A JURY AND TO PARTICIPATE IN A CLASS ACTION AGAINST SMILES CLUB.
If any provision of this arbitration agreement is found unenforceable, the unenforceable provision shall be severed, and the remaining arbitration terms shall be enforced (but in no case shall there be a class arbitration). All Disputes shall be resolved finally and exclusively by binding individual arbitration with a single arbitrator administered by Utah ADR Services, according to this provision and the applicable arbitration rules for said forum.
Consumer claimants (individuals whose transaction is intended for personal, family, or household use) may elect to pursue their claims in their local small-claims court rather than through arbitration. The Federal Arbitration Act, 9 U.S.C. §§ 1-16, fully applies. If you are a consumer bringing a claim relating to personal, household, or family use, any arbitration hearing will occur within the county or parish where you reside or at another mutually agreed upon location.
The arbitrator will conduct hearings, if any, by teleconference, videoconference, or based solely on written submissions, rather than by personal appearances, unless the arbitrator determines upon request by you or by us that an in-person hearing is necessary. Any in-person appearances will be held at a location which is reasonably convenient to both parties with due consideration of their ability to travel and other pertinent circumstances. If the parties are unable to agree on a location, such determination should be made by Utah ADR Services, or a location ordered by the arbitrator.
The arbitrator’s award shall be binding on the parties and may be entered as a judgment in any court of competent jurisdiction. If you prevail on any claim for which you are legally entitled to attorney’s fees, you may recover those fees from the arbitrator. For any claim where you are seeking relief, Smiles Club will not seek to have you pay its attorney’s fees, even if fees might otherwise be awarded, unless the arbitrator determines that your claim was frivolous. The entire arbitration, including the arbitrator’s decision, shall be confidential unless otherwise agreed upon by the parties. For purposes of this arbitration provision, references to you and Smiles Club also include respective subsidiaries, affiliates, agents, employees, predecessors, successors, and assigns.