Informed Consent and History Form.
The Kidlet Oral Appliance Program includes a teledentistry platform which connects you with a licensed dental care provider in your home state who may prescribe Kidlet’s oral appliance products which are used to apply subtle pressure to gradually guide your child’s teeth into a straighter smile, while simultaneously promoting the proper development of your child’s arches and airway. Kidlet’s oral appliances are made from BPA/BPS-free plastic and are designed to be worn in a specific sequence as prescribed by your child’s prescribing dentist. With proper compliance each Kidlet oral appliance will gradually guide your child’s teeth as per the dentist’s treatment plan. While each case is unique, the process typically takes approximately four (4) to fifteen (15) months of active treatment, and possibly longer depending upon the age of the child and other factors.
The information below is intended to assist you in your decision whether or not to use Kidlet’s products, including the risks and benefits associated with this process. The Kidlet Oral Appliance Program may not be appropriate for every child. You may contact Kidlet’s customer care team at customerservices@myKidlet.com or your child’s regular dentist with questions.
This Informed Consent and History Form consists of seven (7) parts:
Risks and Benefits of Kidlet’s Oral Appliance Products
Risks and Benefits of Kidlet’s Telehealth Platform
Informed Consent Agreement to Kidlet Telehealth and Kidlet Oral Appliance Treatment
Patient Dental and Medical History
Healthy Teeth and Gums Acknowledgement
Assignment of Name, Image and Likeness Rights to Kidlet.
Agreement to Arbitrate
Part 1. Risks and Benefits of Kidlet’s Oral Appliance Products
BENEFITS
DISCREET. Kidlet’s oral appliances are made of clear BPA/BPS-free plastic. The trays are thin, lightweight and nearly invisible when worn.
HYGIENE. Because the Kidlet oral appliances can be removed, your child can eat, brush and floss normally. Compliant use may improve your child’s oral hygiene habits.
NATURAL GROWTH and DEVELOPMENT. Kidlet’s oral appliances promote the proper, natural growth and development of pediatric arches.
Kidlet’s oral appliances promote nasal breathing, reduce mouth breathing (bruxism) and correct tongue positioning so as to address the underlying root causes of sleep disordered breathing.
RISKS
DISCOMFORT. Your child’s mouth may be sensitive and, if so, then your child can expect an adjustment period and some minor discomfort associated with moving teeth. Your child may also experience gum, cheek or lip irritation when he/she initially uses an oral appliance while these tissues adjust to contact with the oral appliance trays.
• ALLERGIC REACTION. It is possible for some patients to become allergic to the materials used to create Kidlet’s oral appliances. If your child experiences a reaction, please immediately discontinue use and inform your child’s primary care provider and us so that we may advise your child’s treating dentist.
• TEMPORARY SIDE EFFECTS. Your child may experience temporary changes in their speech or salivary flow while using oral appliances because of the presence of the oral appliance tray in their 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 oral appliances. These reactions are more likely to occur if your child eats or drinks lots of sugary foods or beverages, or does not brush and floss his/her teeth before inserting the oral appliances, or does 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. Your child may have to discontinue oral appliance 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 oral appliances. 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.
• 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 child’s regular dentist detects nerve damage prior or during your child’s oral appliance therapy treatment, then treatment may need to be discontinued.
• TEMPOROMANDIBULAR JOINT DYSFUNCTION (TMJ). Problems may occur in the jaw joints during oral appliance therapy treatment, causing pain, headaches or ear problems. Several factors can contribute to this outcome, including past trauma or injury, arthritis, hereditary history, tooth grinding or clenching and some medical conditions. In the event that your child experiences any of these symptoms, please see your child’s regular dentist.
• IMPACTED AND SUPERNUMERARY TEETH. Teeth may become impacted or trapped below the bone or gums. Sometimes some patients are born with “extra”
(supplementary) teeth. If your child has impacted, un-erupted or supplementary teeth, then oral appliances are not an ideal option.
• SUPRAERUPTION. If a tooth is not properly covered by an oral appliance, it may migrate outwards (supraeruption) leading to difficulty cleaning, gum disease, tooth decay and loss of the tooth.
• PREVIOUS DENTAL TREATMENT. Oral appliances 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 oral appliance therapy and therefore should be removed during treatment. In some circumstances, failure to do so could result in fractures to the oral appliances or broken teeth leading to termination of oral appliance therapy treatment.
• BONDED RETAINER. Bonded retainers, attachments and buttons are contraindications during oral appliance therapy and should be removed prior to oral appliance therapy treatment. Should you choose to proceed with oral appliance therapy treatment for your child, then you must first have your child’s bonded retainers, attachments or buttons digitally removed for purposes of creating your child’s 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 child’s regular dentist before beginning your child’s oral appliance therapy treatment. You are also responsible for consulting with your child’s 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 oral appliances cannot move your child’s teeth effectively with these devices in place and that they must be removed prior to commencing your oral appliance therapy treatment with the Kidlet oral appliances.
• OTHER RISKS. Orthodontic treatment and the movement of teeth present inherent and potential risks and side effects. In the case of oral appliance therapy, such risks include, but are not limited to, discomfort, swelling, sensitivity, numbness, sore jaw muscles, allergic reaction ta 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 oral appliance therapy. The procedure required to treat this, known as a frenectomy, is not a part of your prescribed oral appliance therapy treatment, but is a recommended adjunctive treatment for the best outcome and long-term stability of your child’s smile.
• SAFETY. While it is very unlikely, it is possible that oral appliances may break, be swallowed or inhaled.
• GENERAL HEALTH PROBLEMS. Overall medical conditions such as bone, blood or hormonal disorders, and some prescription and non-prescription drugs (including bisphosphonates) can affect the movement of the teeth and the outcome.
• DURATION AND RESULT. The length of time your child will wear the oral appliances and the results depend on many factors, including, but not limited to the severity of your child’s case, the shape of your child’s teeth, or the amount of time your child wears the oral appliances per day. The average patient generally wears the oral appliances for 4 to 15 months, however your child’s particular rate of tooth movement is impossible to predict with 100% certainty and so 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 your child stops wearing the oral appliances. It is possible that your child may be required to continue to use oral appliances to maintain their teeth’s position for a lifetime. Your child’s 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 child’s bite may change during treatment and may result in temporary discomfort. Your child’s bite may require adjustment after use of the oral appliances.
Alternatives
There are alternatives to oral appliance therapy, including traditional braces, surgical options and simply living with your child’s teeth as they are presently. Your child’s treating dentist can explain these alternatives to you in greater detail.
Part 2. Risks and Benefits of Kidlet’s Telehealth Platform
It is important that you understand the risks and benefits associated with the Kidlet Oral Appliance Program and telehealth technology. The purpose of this Informed Consent agreement is to provide you with important information about the products offered in connection with the Kidlet Oral Appliance Program and the use of the telehealth technology by Kidlet affiliated telehealth dental professionals to determine whether the Kidlet Oral Appliance Program is appropriate for your child. This information is intended to enable you to make an informed decision about whether the Kidlet Oral Appliance Program and the use of telehealth technology is appropriate for your child’s condition and needs.
The Kidlet affiliated telehealth dental professional will be a dentist or orthodontist who is licensed to practice dentistry in the state identified by you during the registration process. The Kidlet affiliated dental professional will assess your request for a Kidlet Starter Kit, which is used by the dental professional to assess whether your child is an appropriate candidate for the Kidlet Oral Appliance Program. This assessment may include an asynchronous review of relevant medical/dental information such as impressions, photographs, images, self-reported data, and a proposed treatment plan. Whether the Kidlet Oral Appliance Program is appropriate for your child is determined by the assessing telehealth dental professional, in his or her sole discretion.
There are benefits associated with receiving care via telehealth technology, including convenience, increased access to care, reduced exposure to infections or diseases and the ability to receive dental/medical care in your home.
There are also risks associated with receiving care via telehealth technology, including that the information you transmit through the telehealth technology may be insufficient or inadequate to allow for appropriate decision-making by the Kidlet-affiliated telehealth dental professional. As with any telehealth platform, Kidlet’s telehealth technology relies upon certain equipment and infrastructure, such as computers, servers, devices, communication lines, power supply and software, which may fail, be subject to interruption and/or result in delay in the provision of care and treatment and/or the loss of information altogether. And while Kidlet employs state of the art security protocols it is nonetheless possible that unscrupulous actors could attempt to gain unauthorized access to your health information. Kidlet strives to prevent unauthorized access to information about you/your child through the encryption of information transmitted by the telehealth technology, however there is no guarantee that your use of the telehealth technology and the information transmitted through same will be private or secure.
Kidlet and its affiliated telehealth dental professionals will rely upon you to provide complete and accurate responses to questions in order to provide products and services to you/your child. This includes the Patient Dental and Medical History and the Healthy Teeth and Gums Acknowledgment found in Part 4 and Part 5 of this Agreement. Your failure to provide accurate or complete information could result in harm or injury to you/your child. You are solely responsible for ensuring that the information submitted by you is, at all times, accurate, complete and current.
Part 3. Informed Consent to Kidlet Telehealth and Kidlet Oral Appliance Treatment
On behalf of myself and my child I hereby consent to use the Kidlet telehealth platform so that a state-licensed dentist and I can engage in telehealth as part of my child’s oral appliance treatment. I understand that ‘telehealth’ includes the practice of health or dental care delivery, diagnosis, consultation, treatment, transfer of medical/dental information, both orally and visually, between me and a state-licensed dentist or orthodontist who has engaged Kidlet, Inc. (d/b/a “Kidlet”) to provide certain non-clinical dental support organization services. I consent to Kidlet sharing my child’s personal and medical information with third parties, business associates and affiliates for the purpose of oral appliance therapy treatment planning and/or product manufacturing.
I understand and acknowledge that Kidlet employees and contractors and the Kidlet-affiliated, licensed dental care professionals in my state responsible for my child’s dental care during the course of my child’s participation in the Kidlet Oral Appliance Program (“Kidlet-affiliated dental professionals”) may provide me/my child with certain products or services, including asynchronous and/or synchronous telehealth technologies.
I certify that I can read and understand the English language. I acknowledge that neither the dentist prescribing my child’s oral appliance therapy treatment nor Kidlet has made any guarantee or assurance to me or my child. I have read this form and fully understand the benefits and risks listed in this form related to my child’s use of Kidlet’s oral appliances. I have had an opportunity to discuss and ask any questions about oral appliance therapy treatment with a licensed state dentist who engaged Kidlet to facilitate my child’s treatment.
I understand that neither the Kidlet-affiliated dentist or orthodontist who prescribed my child’s oral appliance therapy treatment nor Kidlet can guarantee any specific result or outcome. In the event that the reviewing dentist determines that my child is not an appropriate candidate for the Kidlet oral appliance therapy treatment, but that my child is a candidate for more-advanced clear oral appliance treatment protocol, then I consent to having all of my/my child’s records in Kidlet’s possession (including without limitation dental impressions, digital scans, photographs, and medical history documentation) sent to a Kidlet Affiliated Provider for further review and treatment planning, including, but not limited to, contacting me to refer my case to an alternative, Kidlet Affiliated Provider.
Part 4. Patient Dental and Medical History
It is necessary to share your child’s medical or dental history with Kidlet because many diseases, medications and medical/dental conditions can have an effect on how your child’s teeth will respond to oral appliance therapy. A Kidlet affiliated dental professional has at least four years of doctoral and post-doctoral graduate education and is trained and licensed to utilize the information that you provide to determine whether your child is a viable candidate for the Kidlet Oral Appliance Program. It is important that you keep the Kidlet team updated if your child has any changes to their medical or dental history during the course of prescribed treatment. Your child’s medical and dental history is, by law, confidential and will not be released to any other entity or doctor without your written permission.
Dental History
You acknowledge that your child does not have a dental history of:
Pain in any of his/her mouth;
Sores or lumps in or near your child’s mouth;
Head, neck or jaw injuries;
Jaw clicking, pain, difficulty opening and/or closing or difficulty chewing;
Untreated periodontal disease;
Any known allergies to any dental materials.
Medical History
You acknowledge that your child does not have a medical history of:
Currently taking one of the following medications (oral biophosphonates); Fosamax, Actonel, Didronel, Boniva, Aredia, Zometa;
Current acute corticosteroid or immune suppressants;
Bone marrow transplant or treatment of hemotol within the past 2 years.
Authorization and Release:
I certify that I have read and understood the above Patient Dental and Medical History information and that the representations and acknowledgments given by me are true and accurate. I understand that providing incorrect information regarding my child’s dental/medical history could be dangerous to my child’s health. I authorize the prescribing Kidlet-affiliated dental professional to release any information, including the diagnosis and the records of any treatment or examination rendered to my child during the period of such dental care, to third party payors and/or health practitioners. I authorize and request that my insurance company pay directly to the Kidlet-affiliated dental professional (or his/her dental practice) the insurance benefits otherwise payable to me. I understand that my (my child’s) dental insurance carrier may pay less than the actual bill for services. I agree to be responsible for payment of all services rendered for my child.
Part 5. Healthy Teeth and Gums Acknowledgment
Kidlet oral appliances are most effective if your child’s teeth and gums are healthy. It is your responsibility to have your child seen by a dentist within six (6) months prior to starting Kidlet oral appliances, to verify that your child’s teeth and gums are healthy prior to using Kidlet oral appliances. It is also your responsibility to maintain and have follow-up dental care during and after Kidlet oral appliance therapy. By submitting this Informed Consent and History Form, you represent, acknowledge and agree that:
My child has a treating dentist located in my home state who has provided my child with dental care on a regular basis.
My child’s dentist has cleaned my child’s teeth.
My child’s dentist took x-rays of my child’s teeth.
My child’s dentist checked for an repaired any cavities, loose or defective filings, crowns or bridges.
My child’s dentist checked my child’s x-rays and my child has no shortened or resorbed roots.
My child’s dentist checked my child’s x-rays and my child has no impacted teeth.
My child’s dentist has probed or measured my child’s gum pockets and says that my child does not have periodontal or gum disease.
My child’s dentist performed a full oral-cancer screen in the last 6 months and my child does not have oral cancer.
My child has no pain in any of his/her teeth.
My child has no pain in his/her jaws.
I have discussed the Kidlet Oral Appliance Program with my child’s treating dentist and was able to ask questions about the use of clear oral appliances generally and the Kidlet Oral Appliance Program in particular;
That in the event that the Kidlet-affiliated dental professional responsible for determining whether your child is an appropriate candidate for Kidlet oral appliance treatment, determines that additional observation by your child’s personal dentist (i.e. the dentist who performed an in-person exam in the past 12 months) is required to proceed, then I agree to make an appointment and re-certify an attestation addressing the identified concerns within 30 days of my receipt of the concern from the Kidlet-affiliated dental professional. I acknowledge that my child’s treatment may be delayed during this time.
Part 6. Assignment of Name, Image and Likeness Rights to Kidlet.
To the fullest extent permitted by law I hereby grant and assign to Kidlet, Inc., d/b/a “Kidlet” the right to use photographs and/or video clips, as well as stand-alone pictures/graphics in which I or my child may appear or be heard, taken of me/my child and to use my/my child’s first name for the purposes of performing on the parties’ contracts, for educational and/or marketing purposes and for the training of Kidlet employees. I acknowledge that because my and/or my child’s participation is voluntary that neither I nor my child will receive any financial compensation in exchange for this grant and assignment of rights.
I understand and agree that I or my child may be identified by first name and/or title in print, website and/or broadcast information that may accompany the photographs and/or video recordings of me/my child. I waive the right to approve the final product and agree that all such portraits, pictures, photographs, video and/or audio records, and any reproductions thereof, and all plates, negatives, recording tapes and digital files are and shall remain the property of Kidlet.
I hereby release, acquit an forever discharge Kidlet, its current and former directors, agents, officers and employees, 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 agree that my and my child’s participation confers upon me and/or my child no right of ownership. On behalf of myself and my child, I hereby release Kidlet from all liability for any claims by me or my child or any third party in connection with my and/or my child’s participation or use of the Kidlet oral appliance therapy treatment. I also understand that my child’s treatment is not conditioned on my agreement to the use of my child’s photographs or name, and that I can revoke this grant at any time by sending a written revocation to Kidlet, who will then inform my child’s treating dentist.
I warrant that I am at least eighteen (18) years old and competent to contract on behalf of myself and/or my child and that this release is and shall be binding on me and my child, and also my heirs, assigns and/or personal representatives.
Part 7. AGREEMENT TO ARBITRATE.
I agree that any dispute regarding the products and services offered through Kidlet and/or any treatment provided by the Kidlet-affiliated dental professionals referenced herein, 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 agree that any arbitration under this agreement will take place on an individual basis, that class arbitrations and class actions are not permitted. I agree to give up the ability to participate in a class action.
I understand that to initiate the arbitration, I must send a Demand for Arbitration via U.S. Mail, postage prepaid to Kidlet, c/o General Counsel, 950 Green Bay Road, Winnetka, Illinois 60093. 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 the dispute administered and resolved by the Arbitrator in accordance with the American Arbitration Association (“AAA”) Consumer Arbitration Rules and the Supplementary Procedures for Consumer Related Disputes (the “AAA Rules”) then in effect, except as modified by this Agreement to Arbitrate. I acknowledge that the AAA Rules are available for review at www.adr.org/rules and/or by calling the AAA at (800) 778-7879.
I agree to conduct any such Arbitration before an Arbitrator located in Chicago, Illinois. I consent to the Chicago, Illinois-based Arbitrator’s exercise of personal jurisdiction over me/my child and for purposes of Venue. I agree that any party who desires to initiate arbitration must provide the other party with a written Demand for Arbitration as specified in the AAA Rules and that the Arbitrator will be either a retired judge or an attorney specifically licensed to practice law in the state of Illinois and who will be selected by the parties from the AAA’s roster of consumer dispute arbitrators. I agree that if the parties are unable to agree upon an Arbitrator within seven (7) days of delivery of the Demand for Arbitration then the AAA will appoint the Arbitrator in accordance with its Rules.
I agree that the Arbitrator - but not any federal, state or local court or agency - shall have exclusive authority to resolve any disputes relating to the interpretation, applicability, enforceability and/or formation of this Arbitration Agreement, including any claim that all or part of this Arbitration Agreement is void, voidable or otherwise unenforceable. The Arbitrator shall also be responsible for determining all threshold arbitrability issues and any defenses thereto, including, but not limited to, waiver, delay, laches or estoppel.
Notwithstanding any choice of law or other provision of this Informed Consent and History Form, I agree and acknowledge that this Arbitration Agreement evidences a transaction involving interstate commerce and that the Federal Arbitration Act, 9 U.S.C. §1, et seq. (“FAA”), will govern its interpretation and enforcement and proceedings pursuant thereto. I agree that the FAA and AAA Rules shall apply and that supersede and/or supplant all state laws to the fullest extent permitted by law. If the FAA and AAA Rules are found to not apply to any issues that arise under this Arbitration Agreement or the enforcement thereof, then that issue shall be resolved under the laws of the commonwealth of Puerto Rico, USA.
I agree that if my/my child’s claim does not exceed $10,000, then the arbitration will be conducted solely on the basis of documents that I and Kidlet submit to the Arbitrator, unless I request a hearing or the Arbitrator determines that a hearing is necessary. I acknowledge that if my claim exceeds $10,000 then my right to a hearing will be determined by the AAA Rules. Subject to the AAA Rules, the Arbitrator will have the discretion to direct a reasonable exchange of information by the parties, consistent with the expedited nature of the arbitration.
The Arbitrator will render an award within the time frame specified in the AAA Rules. Judgment on the arbitration award may be entered in any court having competent jurisdiction to do so. The Arbitrator may award declaratory or injunctive relief only in favor of the claimant and only to the extent necessary to provide relief warranted by the claimant’s individual claim. An Arbitrator’s decision shall be final and binding on all parties. An Arbitrator’s decision and judgment thereon shall have no precedential or collateral estoppel effect.
The Arbitrator shall, in reaching its decision, declare there to be a prevailing party and, further, that the prevailing party shall be awarded, in addition to such other relief as the Arbitrator may deem appropriate and just, the prevailing party’s reasonable attorneys’ fees, litigation-related expenses, court and other costs incurred by the prevailing party in such proceeding or otherwise in connection with the bringing and/or defense of such suit or action. I acknowledge that my responsibility to pay any AAA filing, administrative and arbitrator fees will be pursuant to the AAA Rules then in effect.
If the terms of this Arbitration Agreement are changed after the date first agreed to this Informed Consent and History Form then I may reject any such change by providing Kidlet with written notice of such rejection within thirty (30) days of the date such change became effective, as indicated in the “Effective” date above. This written notice must be provided by mail or hand delivery to Kidlet’s registered agent for service of process, c/o Kidlet, Attention General Counsel, 950 Green Bay Road, Winnetka, Illinois 60093. In order to be effective, any such Notice must include my/my child’s full name and clearly indicate my intent to reject changes to this Arbitration Agreement. By rejecting changes, I acknowledge and agree to arbitrate any disputes in accordance with the provisions of this Arbitration Agreement as of the date that I first agreed to the Informed Consent and History Form.
If any portion of this Arbitration Agreement is found to be unenforceable or unlawful for any reason, then (1) the unenforceable or unlawful provision shall be severed from these terms; (2) the severance of the unenforceable or unlawful provision shall have no impact whatsoever on the remainder of the Arbitration Agreement or on the parties’ ability to compel arbitration of any remaining claims on an individual basis pursuant to the Arbitration Agreement.
Electronic Signature of Parent/Guardian for Patient: ___________________
On behalf of Name of Pediatric Patient:___________________