Informed Consent

Informed Consent and Patient Agreement

This Dental Consent Form is to be read in conjunction with our terms and conditions and forms part of the contract between you and Diamond Whites Aligners Limited (we, us, our) in respect of our orthodontics aligners services. The definitions in our terms and conditions are used here unless otherwise stated.

We recommend you read the below carefully before your telephone appointment with a Registered Dentist. During your telephone appointment a Registered Dentist will talk you through the treatment, including the risks and you will be given an opportunity to ask any questions before giving consent to treatment. Please note that the treatment cannot go ahead until you have had the telephone appointment and then confirmed you have agreed to the terms in this Dental Consent Form.

Treatment Description

Treatment with clear aligners is an orthodontic treatment that consists of the study of a patient's oral health and medical conditions through a doctor’s diagnosis and sophisticated visualisation software to develop a personalised, custom-made individual treatment plan.

The desired movements will be obtained by using a customised series of removable clear aligner braces that progressively move the teeth in steps. Those movements will be designed and planned in the 3D digitalisation software by doctors that use their special knowledge and professionalism to plan it individually for each patient. The success of the personalised treatment plan depends on the dentist/orthodontist's diagnosis and correct planification of the teeth movement in the visualisation software where the doctor plans the physically viable movements of your teeth step by step.

Once your Dentist/Orthodontist has created your personalised custom made treatment plan, an individualised series of clear aligner braces will be printed.

Benefits of aligners

• Clear aligners offer an aesthetic alternative to conventional braces. Diamond Whites aligners are virtually clear so won’t realise you are undergoing treatment.

• The planned final result can be previewed before starting treatment with Diamond Whites 3D planning and visualisation software. Your treatment will consist of a medical plan in which our Dentists/Orthodontists have carefully organised how to move your teeth step by step to reach the optimal position and to achieve a beautiful and healthy smile.

• The aligners are removable, so you can take them out to drink and eat comfortably, as well as continue with your daily activities without any problem, especially when it comes to sports. The aligners will allow you to maintain your current oral hygiene routine as normal, since they generally do promote the accumulation of additional cavity-causing bacteria in the mouth, or create any other dental problems.

• The aligners do not contain metal wires or brackets associated with conventional braces. Since they’re removable, our aligners allow for normal brushing and flossing, which are often affected by other types of braces.

• The use of aligners, in most cases, means an improvement in the patient’s oral hygiene habits. Many patients improve their brushing and flossing routine by becoming more aware of their dental care and focusing on taking care of it to improve their smile.

• Many Diamond Whites patients may even have better periodontal (gum) health during treatment, due to their improved dental hygiene habits.

• Diamond Whites specialists are able to treat most orthodontic cases with our aligners - from easy to complex problems - often leading to excellent results and perfect smiles.

• We strongly recommend that you perform constant digital follow-up and monitoring of the evolution of your teeth during treatment. This will help avoid unnecessary visits to the clinic.

• You will be able to communicate with our Patient Care Department directly through our mobile application.

• Throughout your treatment, you can choose to finish your treatment in any of Diamond Whites clinics. We adapt to your lifestyle, allowing you to freely change cities throughout your Diamond Whites experience.

Process

Experts Dentists/Orthodontists use modern sophisticated equipment in the clinic and own knowledge and judgement to diagnose and analyse patient’s oral health and medical conditions and collect all medical data in order to create a personalised treatment plan to improve patients oral health conditions. The payment of the treatment represents the acceptance to create a personalised treatment plan and plan teeth movements in the 3D visualisation software to achieve the desired tooth position by the end of the treatment step by step. With the signing of the current agreement, Diamond Whites and its doctors will initiate the planification of your personalised treatment plan that will plan teeth movements in the 3D software until the medically desired tooth position is achieved. With the completion and delivery of 3D personalised treatment planification, will be produced the sets of aligners. Diamond Whites will have fulfilled its obligations by producing the digitalised 3D personalised treatment plan since it is the main part of the treatment.

The total number of aligners will vary depending on the complexity of your case and on the custom treatment created by the specialist. The aligners will be individually numbered with specific instructions for use. You should wear your aligners at least 20-22 hours a day, unless otherwise directed. Only take them off to eat and brush your teeth. Always floss every time you brush your teeth. You should change your aligners for the next ones, with the frequency that is set by your personalised treatment plan. The length of treatment will vary depending on the complexity of your case and specific treatment.

Some patients may require aesthetic attachments attached to their teeth, and/or the use of elastics during treatment, and/or undergo an IPR (interproximal reduction) procedure, in order to facilitate specific movements. This is in order to achieve accurate results in the shortest amount of time possible.

The transparent aligners that are given to you as part of your treatment are produced individually for each patient according to the characteristics and shape of your mouth, and the specific movements to be achieved with said treatment. Each set is totally personalised and unique to you.

Your treatment will begin with a personalised treatment plan demonstrated in 3D. We will design this once you have signed this informed consent, and have paid the entire amount of your treatment, either directly to Diamond Whites, or to a specialised company, if you opt to finance your treatment. To configure your 3D treatment plan, orthodontists will digitally plan the movement of the teeth step by step, in order to achieve your new and improved smile.

As part of the assessment, you may be referred to our partner clinics to perform an intra-oral scanner and a panoramic X-ray. The medical team performing these procedures is acting solely as a service provider for

DIAMOND WHITES and is not responsible for the treatment plan.

The orthodontic treatment provided by Diamond Whites includes the supply of a medical device made according to the characteristics and specifications of your teeth and oral cavity, and produced exclusively and personalised only for you in a non-transferable way. That’s why, given the individualised nature of the aligners, it’s understood that this is a product exempt from the consumers’ and users’ right of withdrawal, included in the dispositions set forth in the Consumers Rights Act of 2015, together with the Consumer Contracts (Information, Cancellation and Additional Charges) Regulations 2013 (Regulations).

Treatment

Treatment with clear aligners is more than just cosmetic, it’s an orthodontic treatment. To accomplish this success, it requires your collaboration and commitment throughout the treatment, as well as constant communication between you and Diamond Whites. In order to achieve the expected results from your treatment plan, you must follow the following instructions:

• Wear your aligners a minimum of 20 to 22 hours a day, and only remove them to eat or drink.

• Maintain a healthy dental routine through proper dental hygiene. You should brush and floss after every meal, and then put your aligners back in, to maintain a healthy mouth.

• Take care of your aligners. Wash the aligners after each meal with neutral soap and a soft toothbrush, with lukewarm water. Be sure not to use hot water, as this can damage the aligners.

• Download the IMPRESS application, through which our team will be able to monitor your progress. You’ll just have to follow the instructions provided in the set up email (you can also contact our team if you need help at any time).

• Use the IMPRESS app to take scans (photos) of your progress every time you change aligners for the next step. Scan your teeth and send photos of these panoramic scans to the patient care team according to the instructions in the mobile app.

• If you have any problems, questions or concerns, please contact Diamond Whites immediately through your mobile application. Problems such as (but not limited to) unusual pain or discomfort, inflammation, blood, gum problems and/or diffculty fitting the aligners properly, must be immediately brought to the attention of our medical team in order to act as quickly as possible and avoid affecting the evolution of your treatment.

• We monitor the application and it is the best way to communicate with us via chat message in the Impress app.

• Keep your aligners secure. When you are not using them, always put them in the case we provide. Since your aligners are actually transparent, it’s very easy to lose them.

• In the event that you lose a set of aligners, please contact our patient service immediately. Your orthodontist will tell you how to proceed. You will most likely be able to continue with the next set of aligners, without needing to make up the missed set. However, in some cases it will be necessary to produce another set of those that were lost. Our medical team will tell you how to proceed. Please note that replacement aligners are custom made and manufactured so will be charged according to the price list.

• Please be on time for your clinic visits. Our price includes emergency visits; however, if you have booked a visit and do not attend it, without having cancelled it at least 24 hours in advance, you will be charged for a visit in accordance with price list. We ask you to collaborate with Diamond Whites to maintain the level of the services that your treatment requires.

Your orthodontic treatment is a personalised and exclusive product for your own use as a patient and is therefore not reimbursable once this Informed Consent is signed.

Risks and Disadvantages

Like all medical treatments, dental and orthodontic treatments in particular and the use of clear aligners involve some risks and disadvantages. By reading and signing these Informed Consent, you are certifying that you understand that any of the risks and/or disadvantages described in this section may occur, and, therefore, you agree that you will not be able to make any claim against Diamond Whites if any of the following situations occur:

• The aligners may temporarily affect your pronunciation. Until you adapt to using each set, it’s possible that when the aligners are changed, you may notice that your speech is altered. However, most patients adapt quickly, and it is unusual for pronunciation to be affected for a long period of time.

• The aligners can cause a temporary increase in salivation, or, conversely, dry mouth. If you regularly take certain medications, this can increase these symptoms.

• If the patient uses the aligners out of the sequence prescribed by the Dentist/Orthodontist, it could delay the results of the treatment and cause complications and discomfort for the patient. Use the aligners only in the order indicated by your specialist, and proceed to change them sequentially as indicated.

• The initial treatment plan can be altered for different reasons and extend over time longer than initially planned. This can be due to many situations, such as not using the aligners the minimum number of hours indicated per day, not submitting your oral scans to your specialist at the indicated time, not maintaining proper oral hygiene and/or not properly cleaning the aligners. It could also be due to individual and particular characteristics of your teeth, roots, gums, the atypical shape of your teeth, and/or the general state of health of your mouth, or if periodontal diseases, decalcification, or any other problems that arise appear unexpectedly. In any of these situations, your treatment may be temporarily suspended, lengthened, or even stopped, until your oral health is fully restored.

• There may be an adaptation period to using the aligners, during which they may cause discomfort. There is also potential for cases of excessive dental sensitivity due to the forces exerted on the teeth or jaw.

• Aligners can cause discomfort to the teeth and irritation to the gums, lips, cheeks and tongue, including sores or soft tissue irritation. These discomforts are generally felt during the start of treatment or when changing the aligners, but in most cases they disappear within a few days.

• There is a possibility that additional orthodontic treatment will be needed, including the use of attachments bonded to your teeth, elastics, orthodontic chewies, auxiliary appliances, dental appliances (ex. temporary anchorage devices, fixed sectional appliances), and/or restorative dental procedures. They can be required in more complicated treatments in which it is necessary to resort to alternative measures to be able to perform diffcult dental movements. The use of such auxiliary devices may mean that you are more sensitive to treatment. Such devices may fall off and require replacement. They will be removed once the treatment is finished.

• In cases of crowded teeth, it may be necessary to apply the interproximal reduction (IPR) technique, in order to reduce the thickness of your dental enamel to create enough space for tooth movement. In any case, you will be notified by your specialist.

• If you consume sugary foods or drinks, do not maintain proper dental hygiene by frequent brushing and flossing before putting on your aligners, or do not perform preventive maintenance of your oral health during treatment, cavities, periodontal diseases, inflammation of the gums or permanent marks (eg, decalcification) may occur.

• Allergic reactions may occur.
• Your bite may change throughout the treatment, which may cause temporary discomfort.

• Treatments for severe open bite, severe overhang, mixed dentition and/or skeletally narrow jaw may require complementary treatments in addition to aligner treatment.

• General medical conditions and the use of medications may affect orthodontic treatment.

• The dental pieces that have been damaged or significantly restored prior to the treatment, are especially vulnerable to damage by the orthodontic treatment. In some cases, these alterations can cause changes in the useful life of the tooth, reducing it, so that said dental pieces may require additional dental treatment, such as a root canal and/or additional restoration work and/or in cases serious, the loss of the tooth.

• Pre-existing dental restorations to orthodontic treatment (ex. crowns), can become detached and even require new cementation or, in some cases, replacement.

• In cases of severe crowding or missing teeth, the chances of the aligner breaking increase. If this occurs, please contact your Diamond Whites orthodontist and our Patient Care Department immediately so that we can provide a replacement as soon as possible.

• Any dental eruption (for example, wisdom teeth), as well as growth of the jaw or bone subjected to orthodontic forces, may require changes to the treatment plan initially developed by your orthodontist. Sometimes requiring extractions of permanent teeth to create space and therefore, the duration of the treatment is extended in time. Dental eruptions developed after treatment can cause alterations in the results obtained, and can even modify the alignment of the teeth. The factors of dental eruption are very diffcult for the specialist to predict even after carrying out the tests prior to developing your plan. In some cases, it may be due to temporary (baby/milk) teeth, which have not fallen out for any reason. On these occasions it will be necessary to extract them. Due to the process of bone development and the unforeseen eruption of teeth, treatment may take longer than planned.

• Some patients are more susceptible to root resorption (shortening) when they are subjected to orthodontic forces. This phenomenon is rare and is unpredictable. Usually, this does not have significant consequences, but on occasions it can affect the longevity of the tooth and would imply altering the treatment plan. In isolated cases, root resorption could cause the loss of the affected tooth. The nerves of the teeth are also at risk if they have previously suffered trauma from an accident or deep decay. It is possible that due to orthodontic movement, this situation worsens and a root canal or any type of endodontic treatment should be performed.

• During orthodontic treatment, due to the effect of dental movements, periodontal diseases can develop or worsen (if pre-existing). This can also lead to receding gums, which are impossible to predict at the time of your treatment plan. Likewise, they may appear hypertrophied as a consequence of the accumulation of bacterial plaque. If periodontal, gum, and bone problems cannot be controlled, orthodontic treatment may need to be withheld until periodontal stability is achieved.

• There is a possibility of discomfort or pain in the temporomandibular joint due to the modification of the occlusal pattern necessary for correct dental alignment. Jaw joint problems can occur, causing jaw pain, headaches, or ear problems. There are many factors that can affect joint health, including past trauma, arthritis, bruxism, an unbalanced bite, and multiple medical conditions. Temporomandibular joint problems can occur with or without orthodontic treatment. Any temporomandibular joint symptoms should be reported immediately to your orthodontist.

• Embedded, retained, ankylosed and/or non-erupted teeth have a more complex treatment and the result of these cannot be guaranteed even once the treatment is finished. Teeth can become trapped under the bone or gum, become stagnant (fused to the bone), or fail to erupt. Often these situations occur for no apparent reason and are generally not foreseeable. There is also the possibility that a damaged tooth damages the root of neighbouring teeth, sometimes even causing the loss of the tooth. Sometimes treatment can fail due to dental ankylosis, which is impossible to diagnose before treatment and would require extraction. Your specialist may recommend that you remove the impacted tooth before treatment and replace it with an implant if necessary.

• At the end of orthodontic treatment, the bite may require adjustment ("occlusal adjustment").

• If you wear aligners and dental prosthetics (such as crowns or dental bridges), they may be affected and/or weakened and may require adjustment or replacement. Before beginning treatment with dentures, please talk to our team to see if it’s possible and if it could affect the way your aligners fit in your mouth.

• Teeth that are not at least partially covered by the aligner may suffer from supraeruption.

• In extreme cases, root resorption could lead to tooth loss.

• Rarely, patients with hereditary angioedema (HAE), a genetic disorder, may experience rapid local swelling of subcutaneous tissues, including the larynx. HAE can be triggered by mild stimuli, including dental procedures.

• Orthodontic devices or parts thereof can be accidentally swallowed or aspirated.

• The bones and gums that support the teeth can be affected by the use of aligners. In some cases, the condition of these bones and gums could be affected or worsened by the treatment itself.

• In some cases, a “black triangle” related to missing gingival tissue may be seen below the interproximal contact, when the teeth align after being superimposed for a long period of time.

Our Promise

The movement of the teeth depends on the state of health, care, hygiene and allergies of the individual. Each person and their characteristics are unique. In rare cases, clients may require refinement with extra clear aligners, other conventional techniques, and/or aesthetic procedures, such as crowns or onlays, to achieve the final result.

However, we will try to ensure that you get the best possible results with the treatment that we suggest:

• We may use additional IPR and orthodontic techniques in addition to the planned treatment (there will be an extra charge for this).

• An orthodontic treatment is a medical treatment and Diamond Whites cannot guarantee any results. In particular, we are under no obligation to provide any refinement aligners or treatment if the treatment is not achieving the results you expected.

• In order to maximise your chances of a successful treatment, you must comply with the orthodontist's instructions: to reiterate, you must wear your aligners for a minimum of 20-22 hours per day, complete your scans via the app every 7 days as needed, and attend any required clinic visits.

• If refinement aligners are required, they will cost £250 which will increase to
£500 after 90 days of last check in. If this time exceeds 12 months, the charge will be 50% off full price. If you inform us about your dissatisfaction within 30 days from the last check, we may at our sole discretion waive these charges (and you acknowledge that we are under no obligation to provide any refinement aligners for free).

• In order to finish your treatment successfully you must provide scans of your teeth via our app as instructed by your doctors.

• From time to time, an aligner may not fit for reasons relating to the material or due to the individual and personalised nature of the product. In this case, provided we agree that there are issues with the aligners we provided and you have informed us within 7 days of receiving them, we will provide you with new aligners.

Post Treatment

Teeth continue to move as a natural part of life. They may change position after treatment. Consistent use of retainers at the end of treatment should reduce this tendency. To maintain the best long-term results, we recommend that you visit Diamond Whites 6 months after finishing treatment for your first check-up, 12 months later for the second check-up, and 18 months later for the third check-up. We recommend changing your retainers every 6 months to keep them fresh and maintain a constant level of pressure on your teeth overnight.

If you purchased a retainer at the start of your treatment and you have received refinement aligners, we may at our sole discretion waive the charge for replacement retainers.

Declaration

I have been given adequate time to read the above information describing orthodontic treatment with clear aligners. I understand the benefits, risks, alternatives and disadvantages associated with the treatment, and I accept and assume them as part of it; as well as the option of not continuing with the treatment.

In any case, I assume that, in the event of wanting to discontinue with the treatment, I will not have the right to be reimbursed for the amount paid and committed for it, as Diamond Whites has started a personalised custom-made medical treatment that represents the orthodontic study and medical planification of the treatment for me with the help of digital tools designed solely for my personal and non- transferable use.

I have been suffciently informed and have had the opportunity to ask questions and discuss concerns about orthodontic treatment with the professional from whom I intend to receive treatment. Due to the fact that orthodontics is not an exact science, I acknowledge that my orthodontist, Diamond Whites have not and cannot guarantee the outcome of my treatment. No assurances or guarantees of any kind have been given to me by my orthodontist, Diamond Whites their representatives, team members, and agents with respect to any specific result of my treatment.

I understand and consent to the collection and use of my medical records by my orthodontist, including, but not limited to, radiographs (X-rays), reports, charts, medical history, photographs, findings, plaster models, dental or intraoral impressions, scans, prescriptions, diagnoses, medical tests, test results, ethnicity, billing, and other treatment records in the possession of my orthodontist as deemed necessary for the progress of treatment. I also consent to their use by Diamond Whites so that they can offer me proper Patient Care service, and billing. If I do not consent to these uses of my medical records, I may not be able to receive Diamond Whites orthodontic treatment.

I will not, nor will anyone on my behalf, pursue legal, equitable, or monetary damages or actions for any such disclosure. I acknowledge that the use of my medical records is without financial compensation and that neither I nor anyone on my behalf shall have any rights of approval, claim for compensation, nor will I seek or obtain legal, equitable or monetary damages or actions arising out of any such use. I agree to comply with the terms of this consent. I give permission to use my anonymous data and share the results of orthodontic treatment for study in materials for physicians, social media, and Diamond Whites websites.

A copy of this Consent will be considered as effective and valid as the original. I have read, understood and agree to the terms set forth in this Consent.