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Informed Consent 

How Does Strayt Clear Aligner Therapy Work?

Strayt's clear 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 Strayt aligner therapy system - and you follow your treating dentist’s instructions - you will receive the best possible outcome available using the Strayt clear aligner therapy treatment. Feel free to contact the Strayt 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 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.
  • 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 Strayt 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. 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.

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 IRRITAION – 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

Strayt 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 Strayt aligners, to verify that your teeth and gums healthy prior to using Strayt aligners. It is also your responsibility to maintain and have follow-up dental care during and after Strayt aligner therapy.

AGREEMENT TO ARBITRATE

AGREEMENT TO ARBITRATE – I hereby agree that any dispute regarding the products and services offered through Strayt 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 Paul Heapy, Strayt, LLC, 9482 W Frank Avenue, Peoria, AZ 85382. 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.

Informed Consent

TELEHEALTH - I hereby consent to use Strayt’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 Strayt to provide certain non-clinical dental support organization services.

By signing this Informed Consent, 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 probed 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 of my permanent teeth are present.

I further consent to Strayt 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 acknowledge that neither the dentist prescribing my aligner therapy treatment nor Strayt 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 Strayt aligners and whitening system. I have had an opportunity to discuss and ask any questions about aligner therapy treatment with a licensed state dentist who engaged Strayt to facilitate my treatment. I understand that neither the dentist who prescribed my aligner therapy treatment nor Strayt can guarantee any specific result or outcome. I further understand that my clear aligner therapy treatment will only address the alignment of my teeth and will not correct my existing bite condition. In order to correct the current condition of my bite, I will need to seek more comprehensive treatment via my local dental professional. 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 hereby grant Strayt 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. I release Strayt from liability for any claims by me or any third party in connection with my participation or use of the clear 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 Strayt, who will then inform my treating dentist.

In the event that the dentist who reviews my chart and other information that I submit determines that I am not an appropriate candidate for the Strayt aligner therapy treatment, I hereby consent to having all of my records in Strayt's possession (including without limitation dental impressions, digital scans, photographs, and medical history documentation) sent to a dentist or orthodontist for further review and treatment planning, including, but not limited to, contacting me to refer my case to an provider of my choosing or to market and sell me products or services.

 
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