PATIENT INFORMED CONSENT AND AGREEMENT

INFORMED CONSENT AND AGREEMENT REGARDING ORTHODONTIC TREATMENT FOR THE PATIENT
Your dentist has recommended the TrioClear™ clear aligner system for your orthodontic treatment. 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 TrioClear™ aligners) has limitations and potential risks that you should consider before undergoing treatment. Results may vary and the Treatment Plan and iDesign Clinical Simulation represent an approximate guide for reference only.

DEVICE DESCRIPTION
TrioClear™ aligners, developed by Perfection Aligner System Hong Kong Limited, consist of a series of clear thermoplastic, removable appliances that move your teeth in small increments. TrioClear™ combines your dentist’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 dentist, a series of customised TrioClear™ aligners are produced specifically for your treatment.

PROCEDURE
You may undergo a routine orthodontic pre-treatment examination including radiographs (x-rays) and clinical photographs. Your dentist will take impressions or intraoral scans of your teeth and send them along with a prescription to the TrioClear™ laboratory. TrioClear™ technicians will follow your dentist’s prescription to create a treatment plan and 3D simulation. Upon approval of the treatment plan by your dentist, TrioClear™ will manufacture and deliver a series of customised aligners to your dentist. The total number of aligners will vary depending on the complexity of your malocclusion and the approved treatment plan. The aligners will be individually numbered and will be dispensed to you by your dentist with specific instructions for use. Unless otherwise instructed by your dentist, you should wear your aligners for approximately 22 hours per day, removing them only to eat, brush and floss. You will switch to the next aligner in the series as directed by your dentist. Treatment duration varies depending on the complexity of your dentist’s prescription. Unless instructed otherwise, you should follow up with your dentist at a minimum of every 6 to 8 weeks. Most patients will require bonded aesthetic attachments and / or the use of elastics during treatment to facilitate specific orthodontic movements. Patients may require additional impressions or intraoral scans and / or refinement aligners after the initial series of aligners.

BENEFITS
Compared to most other clear aligner brands which only use single-thickness aligner materials, TrioClear™ utilises progressive thickness aligners ranging from soft to hard, allowing your teeth to adjust easily when the movement occurs. Our soft aligner is around 0.5mm, which means your teeth may feel less pressure and pain during every first stage of the movement.

TrioClear™ aligners are not only custom-made to fit your teeth, but they are made to comfortably and partially fit over your gums, ensuring that both your teeth and gums are safely protected as they shift into your ideal position.

TrioClear™ aligners offer an aesthetic alternative to conventional braces.

Clear aligners are virtually invisible so many people will not realise you are undergoing an orthodontic treatment.

Treatment plans can be visualised through the TrioClear™ iDesign clinical simulation software.

Aligners allow for normal brushing and flossing tasks that are generally impaired by conventional braces.

Aligners do not have the metal wires or brackets associated with conventional braces.

RISKS AND INCONVENIENCES
Like other orthodontic treatments, the use of TrioClear™ product(s) may involve some of the risks outlined below:

1. Failure to wear the aligners for the required number of hours per day, failure to use the aligner as directed by your dentist, missing appointments, and erupting or atypically shaped teeth can lengthen the treatment time, affect the ability to achieve the desired results, and may increase treatment length and fees. It is possible that the end result of the simulation will not match the clinical end result;
2. Dental tenderness may be experienced after switching to the next aligner in the series;
3. Gums, cheeks and lips may be scratched or irritated;
4. Teeth may shift position after treatment. Consistent wearing of retainers at the end of the treatment should reduce this tendency;
5. Tooth decay, periodontal disease, inflammation of the gums or permanent markings (e.g. decalcification) may occur if patients consume foods or beverages containing sugar, do not brush and floss their teeth properly before wearing the TrioClear™ products, or do not use proper oral hygiene and preventative maintenance;
6. The aligners may temporarily affect speech and may result in a lisp, although any speech impediment caused by the TrioClear™ products should disappear within one or two weeks;
7. Aligners may cause a temporary increase in salivation or mouth dryness and certain medications can heighten this effect;
8. Attachments may be bonded to one or more teeth during the course of treatment to facilitate tooth movement and/or appliance retention. These will be removed after treatment is completed;
9. It is possible that an attachment can come off during the treatment. If this occurs, please contact your dentist to report this immediately.
10. Teeth may require interproximal recontouring or slenderising in order to create space needed for dental alignment to occur;
11. The bite may change throughout the course of treatment and may result in temporary patient discomfort;
12. In rare instances, slight superficial surface wear of the aligner may occur where patients may be grinding their teeth or where the teeth may be rubbing and is generally not a problem as overall aligner integrity and strength remains intact;
13. At the end of orthodontic treatment, the bite may require adjustment (“occlusal adjustment”);
14. Atypically shaped, erupting and/or missing teeth may affect aligner adaptation and may affect the ability to achieve the desired results;
15. Treatment of severe open bite, severe overjet, mixed dentition, and/or skeletally narrow jaw may require supplemental treatment in addition to aligner treatment;
16. Supplemental orthodontic treatment, including the use of bonded buttons, orthodontic elastics, auxiliary appliances / dental devices (e.g. temporary anchorage devices, sectional fixed appliances), and/or restorative dental procedures may be needed for more complicated treatment plans where aligners alone may not be adequate to achieve the desired outcome;
17. Teeth which have been overlapped for long periods of time may be missing the gingival tissue below the interproximal contact once the teeth are aligned, leading to the appearance of a “black triangle” space;

18. Aligners are not effective in the movement of dental implants;
19. General medical conditions and use of medications can affect orthodontic treatment;
20. Health of the bone and gums which support the teeth may be impaired or aggravated;
21. Oral surgery may be necessary to correct crowding or severe jaw imbalances that are present prior to wearing the TrioClear™ product. If oral surgery is required, risks associated with anesthesia and proper healing must be taken into account prior to a TrioClearTM treatment;
22. A tooth that has been previously traumatised, or significantly restored may be aggravated. In rare instances the useful life of the tooth may be reduced, the tooth may require additional dental treatment such as endodontic and/or additional restorative work and the tooth may be lost;
23. Existing dental restorations (e.g. crowns) may become dislodged and require re-cementation or in some instances, replacement;
24. Short clinical crowns can pose appliance retention issues and inhibit tooth movement;
25. 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;
26. Product breakage is more likely in patients with severe crowding and/or multiple missing teeth;
27. Orthodontic appliances or parts thereof may be accidentally swallowed or aspirated;
28. In rare instances, problems may also occur in the jaw joint, causing joint pain, headaches or ear problems;
29. Allergic reactions may occur;
30. Teeth that are not at least partially covered by the aligner may undergo supraeruption;
31. In rare instances, patients with hereditary angioedema (HAE), a genetic disorder, may experience rapid local swelling of subcutaneous tissues including the larynx, HAE may be triggered by mild stimuli including dentalprocedures.
32. As third molars (wisdom teeth) develop, your teeth may change alignment. Your dentist should monitor them in order to determine when and if the third molars need to be removed.
33. During treatment, it may be necessary to rewear previous (worn) aligners so it is important to keep all worn aligners properly until the end of treatment.

RETENTION
At the end of the treatment, we recommend the use of retainers or else the teeth will shift and move back to the original position. Your dentist will discuss and prescribe the most appropriate retention protocol for you. Be it fixed wires, removable retainers or a combination of both. We recommend the “Ecodont™ Retainer” if the removable option is prescribed for you. They should be worn long-term to prevent your teeth from moving and will need to be changed from time to time as they will wear, soften or break depending on how you treat them and your grinding habits. You should continue seeing your dentist who will monitor your retainers and they will advise you how often to change them.

INFORMED CONSENT
I have been given adequate time to read and have read the preceding information describing an orthodontic treatment with TrioClear™ aligners. I understand the benefits, risks, alternatives and inconveniences associated with treatment as well as the option of no treatment. I have been sufficiently informed and have had the opportunity to ask questions and discuss concerns about orthodontic treatment with TrioClear™ products with my dentist from whom I intend to receive treatment. I understand that I should only use the TrioClear™ product after consultation and prescription from my dentist, and I hereby consent to orthodontic treatment with the TrioClear™ product that has been prescribed by my dentist. Due to the fact that orthodontics is not an exact science, I acknowledge that my dentist and Perfection Aligner System Hong Kong Limited have not and cannot make any guarantees or assurances concerning the outcome of my treatment. I understand that TrioClear™ is not a provider of medical, dental or health care services and does not and cannot practice medicine, dentistry or give medical advice. No assurances or guarantees of any kind have been made to me by my dentist or Perfection Aligner System Hong Kong Limited, its representatives, successors, assigns, and agents concerning any specific outcome of my treatment.

I authorise my dentist to release my medical records, including, but not limited to, radiographs (x-rays), scans, reports, charts, prescriptions, medical history, photographs, findings, plaster models or impressions of teeth, diagnosis, medical testing, test results, invoicing, and other treatment records in my dentist’s possession (“Medical Records”) (i) to other licensed dentists or and organisations employing licensed dentists and orthodontists and to TrioClear™, its representatives, employees, successors, assigns, and agents for the purposes of investigating and reviewing my medical history as it pertains to orthodontic treatment with the product(s) from Perfection Aligner System Hong Kong Limited and (ii) for educational and research purposes. A photocopy of this Consent shall be considered as effective and valid as an original. I have read, understand and agree to the terms set forth in this Consent as indicated by my signature below.