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Consent Form

Introduction

Self-ie™ provides dental products and services via a digital platform that allows registered, licensed dental professionals to deliver care remotely for patients, at an affordable price.

Why do I need to read this form?

This document outlines all the information you should know and understand before proceeding with Self-ie™ aligners and whitening. It is important that you read and understand it all before agreeing to proceed. Although orthodontic treatment can lead to a healthier and more attractive smile, you should also be aware that any orthodontic treatment (including orthodontic treatment with Self-ie™ aligners and whitening) has limitations and potential risks.

If our dental professionals deem that you are a suitable candidate for Self-ie™ clear aligners and teeth whitening, you should be aware of and fully understand the benefits, risks, limitations and alternative options available to you before you decide to use aligners and tooth whitening products. You should also understand how remote treatment (Teledentistry) differs from conventional methods of providing braces.

If anything is unclear, now or at any time throughout your journey with Self-ie, feel free to contact our care team. We are always here to help.

Device Description

Self-ie™ aligners are a series of clear, removable, BPA-free plastic aligners that apply subtle pressure to the teeth to gradually shift them into improved, straighter positions. Self-ie’s product combines your dental professional’s diagnosis and prescription with sophisticated computer graphics technology to develop a treatment plan which specifies the desired movements of your teeth during the course of your treatment. Upon approval of a treatment plan developed by your dental professional, a series of customised Self-ie™ aligners is produced specifically for your treatment. The clear aligners are made to be worn in a specific sequence, starting from Step 1 and continuing until the endpoint prescribed. While every case Self-ie™ treats is unique, the process typically takes about 6 – 9 months to complete.

During treatment, an optional tooth whitening system may be used, which will also be prescribed by the dental professional treating you. This system uses a special formulation of hydrogen peroxide to gently remove stains and whiten your teeth while you wear your aligners.

Teledentistry description

Teledentistry includes the practice of dental care delivery, diagnosis, consultation, treatment, and transfer of medical/dental information, between you and a treating registered dental professional who has engaged Self-ie™ to provide certain non-clinical dental services. The digital platform used by Self-ie™ allows our registered dentists to deliver great care for patients, remotely involving highly skilled dental professionals, at an affordable price. However, this service is not a replacement for your general dentist. Our aligners are most effective if your teeth and gums are healthy. We will do our best to spot any potential dental problems you may have and advise you appropriately, but it is ultimately your responsibility to see a dentist to verify that your teeth and gums are healthy prior to using Self-ie™ aligners. It is also your responsibility to maintain and have follow-up dental care during and after your treatment with us. At Self-ie™, we will be happy to recommend a dentist to you, if you currently do not regularly see one.

Benefits

Normally, excellent results can be achieved with close cooperation between you, your registered treating dentist, and the team at Self-ie. The benefits you can expect from the Self-ie aligner system are:

Self-ie aligners are designed to improve the alignment of your teeth, making them straighter and giving you a more pleasing smile and appearance.
A simulation of your treatment plan can be viewed before you start treatment
The whitening system may lighten the colour of your teeth.
Aligners are thin, light weight and nearly invisible when worn - many people won't even know you're wearing them.
As the aligners can be removed, you can eat, brush and floss normally, and the process of using aligners may improve your oral hygiene and food consumption habits.

Aligner risks and inconveniences

Like other orthodontic treatments, the use of Self-ie™ product(s) may involve some of the risks outlined below:

It is possible for some patients to have allergies, or to become allergic to the materials used to create your aligners
Orthodontic appliances or parts thereof may be accidentally swallowed or aspirated
The aligners may fracture, especially if not handled carefully
Dental tenderness may be experienced during the first aligner, and after switching to the next aligner in the series
Gums, cheeks and lips may be scratched or irritated
Failure to wear the appliances for at least 22 hours per day, not using the product as directed by your dental professional, missing check-ins and erupting or atypically shaped teeth can lengthen the treatment time and affect the ability to achieve the desired results
You may experience temporary changes in your speech and the amount of saliva in your mouth while wearing aligners
Cavities, tooth decay, periodontal disease, gingival recession, inflammation of the gums or permanent markings on the teeth (demineralisation) 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 drinks, 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
The health of the bone and gums which support the teeth may be impaired or aggravated
If you have underlying periodontal (gum) conditions, these will not be improved/resolved by the use of either the aligners or whitening products
The length of the roots of the teeth may be shortened during orthodontic treatment and may become a threat to the useful life of teeth
If a primary (or "baby") tooth is present, any orthodontic movement will accelerate the resorption of its roots, leading to loss of the tooth
Teeth have a tendency to return to their original positions after orthodontic treatment. Consistent wearing of retainers at the end of treatment should reduce this tendency
Tooth movement may cause or accelerate tooth nerve damage or nerve death, resulting in the need for root canal therapy, other dental treatment, or loss of the tooth
The bite may change throughout the course of treatment and may result in temporary patient discomfort such as dental pain, muscle pain, jaw joint pain, headaches or ear problems
Teeth that are not at least partially covered by the aligner may overerupt which may interfere with the bite
Short teeth can pose appliance retention issues and inhibit tooth movement
Aligners will not move implants or teeth splinted together with a bonded retainer. They may also not be effective on some dental restorations, such as bridges, and may damage or dislodge them. Additionally, dental restorations, such as crowns, veneers, or bridges, may eventually require replacement due to tooth movement.
Oral piercings may fracture the aligners. If these are not removed and cause fractures, treatment may have to be discontinued
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. You should inform us of any medications you are currently taking, and update us if this information changes
Your bite may change during treatment and may result in temporary discomfort. Your bite may require adjustment after use of the aligners
Teeth which have been overlapped for long periods of time may be missing the gum tissue and when these teeth are straightened, a "black triangle" appears between them
In rare instances, patients with hereditary angioedema (HAE), a genetic disorder, may experience rapid local swelling of subcutaneous tissues including the larynx, HAE has been known to be triggered by mild stimuli including dental procedures

Whitening risks and inconveniences

Like other whitening treatments, the use of Self-ie™ product(s) may involve some of the risks outlined below:

The whitening system will not lighten all types of stains. Blue, grey, multi–coloured, or striped discoloration may not respond well to whitening.
Restorations such as fillings, crowns, veneers, or implants will not lighten in colour. Cavities or other damage to the teeth will not lighten either
Existing white fillings may no longer match the colour of teeth after whitening and may need to be replaced
Tooth sensitivity may occur during initial use
Gum irritation may arise from improper use of whitening system, as might throat irritation if whitening agent is swallowed.
Whitened teeth will darken again over time. Cigarettes, wine, coffee, tea, soy sauce and similar stain producing agents will cause darkening of the teeth more quickly.

Limitations of aligner treatment

Aligners are not suitable for all orthodontic problems, nor do they deliver the same result as traditional braces in all cases
The advantages of Self-ie™ clear aligners make them the right choice for many people, but if the perfect outcome is your goal, aligners may not be right for you
Your treating registered dental profession may not be able to design a treatment plan that achieves all aspects of your treatment goals
The length of time you need to 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, and any damage or loss of aligners throughout treatment
The average person generally wears the aligners for 6 – 9 months, but your particular rate of tooth movement is impossible to predict and could take longer
If you do not wear the aligners for a minimum of 22 hours per day, your treatment time may be extended or you may need additional aligners at the end of treatment to reach your treatment goals. These may be charged at additional cost.
If aligners are lost/damaged during treatment and require replacement, the time taken to manufacture and deliver a replacement set will result in an extension of your overall treatment time. There will be additional charges for replacement aligners.

Alternative options to Self-ie™ Aligners

Do nothing. No one has ever died from having crooked teeth! We would be sorry to see you go, but will fully support your decision if you decide not to proceed with any orthodontic treatment.
Comprehensive orthodontic treatment: For optimum results, orthodontic brackets and wires placed and regularly adjusted by a registered specialist orthodontist will still be expected to give the best outcomes. This type of treatment carries its own risks and limitations, which are generally similar to that outlined above, and there are differences in terms of time and costs involved. If you feel this option is right for you, however, we won’t stand in your way. In fact, Self-ie has curated a list of top orthodontists in multiple countries across South East Asia, and we will even arrange to refer you to one of their clinics if you wish.

Informed Consent

By signing/indicating my agreement with this Informed Consent document, I understand that I am certifying that:

I certify that I can read and understand English
I have been given adequate time to read and have read the preceding information
I acknowledge that neither the dentist prescribing my aligner therapy treatment nor Self-ie™ has made any guarantee or assurance to me.
I understand that neither the dental professional who prescribes my aligner therapy and whitening treatment nor Self-ie™ can guarantee any specific result or outcome.
I have read this form and fully understand the benefits, risks and limitations listed in this form related to my use of Self-ie™ aligners and whitening system.
I understand that Self-ie™ provides convenience through the use of "teledentistry". In other words, most or all of my interaction with the treating dental professional is indirect and through the internet. It is unlikely that I will have a face to face interaction with the treating orthodontist, and certain care that may be typical in face to face treatment (such as dental cleaning, general oral examination) will NOT occur. I understand treatment is being rendered by a licensed dental professional. I accept that teledentistry treatment is different from face to face treatment, and that it is advisable that I obtain face to face treatment for regular dental care, screening and other dental issues. I specifically prefer to obtain this service, related to the development of an aligner treatment plan and the use of aligners, through a teledentistry approach.
I understand that Self-ie™ is not a provider of medical, dental or healthcare services and does not and cannot practice dentistry, medicine, or give health advice.
I have had an opportunity to discuss and ask any questions about aligner therapy and whitening treatment with a treating licensed dental professional who has engaged Self-ie™ to facilitate my treatment.
I further understand that my clear aligner therapy treatment will only address the alignment of my teeth and will not correct underlying skeletal/jaw problems or problems with my bite. In order to correct these, if present, 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 release Self-ie™ 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 hereby consent to the processing of personal data relating to my oral and dental health, and any other relevant health information, for the purposes of receiving the aligner therapy products and services for which I have contracted with Self-ie™.
I understand that I am free to choose whether to provide my consent, and that my consent can be withdrawn at any time by contacting Self-ie™. Withdrawal of my consent will not affect the lawfulness of any actions by Self-ie™ or my registered treating dental professional previously based on consent. The effects of withdrawing consent will vary, depending on the stage at which consent is withdrawn. However, I understand that, if I withdraw my consent, Self-ie™ may be unable to continue providing me with the contracted products and services. I further understand that my dentist's processing of my health data is not contingent on this consent, and will be carried out under a separate legal basis.
I confirm that I have no pre-existing dental conditions that I am aware of, and that I undergo routine dental care.