Informed Consent to Invisalign^® Treatment

Your doctor has recommended the Invisalign^® system for your treatment. Although orthodontic treatment can lead to a healthier and more attractive smile, you should also be aware that any orthodontic treatment has limitations and potential risks that you should consider.

Orthodontic treatment promotes a healthy smile, healthier teeth and gums, and a better bite. Much of its success depends on the understanding and cooperation of the patient. This form covers the usual material risks associated with orthodontic treatment.

You may ask your orthodontist to explain anything you do not understand. While recognising the benefits of healthy teeth and a pleasing smile, you should also be aware that orthodontic treatment has limitations and potential risks and there may be alternative treatment options.

Keep in mind that with orthodontic treatment, like other healing arts, results cannot be guaranteed. The unknown factor in any orthodontic correction is the response of the patient to the orthodontic treatment. Should you have any questions, please ask.

Device description

Invisalign^® aligners, developed by Align Technology, Inc. (“Align”) consist of a series of clear plastic, removable appliances that move your teeth in small increments.

Invisalign^®’s product combines your doctor’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 doctor, a series of customised Invisalign^® aligners is produced specifically for your treatment.

Invisalign^® procedure

You may undergo a routine orthodontic pre-treatment examination including radiographs (x-rays) and photographs. Your doctor will take impressions or intraoral scans of your teeth and send them along with a prescription to the Align laboratory.

Align technicians will follow your doctor’s prescription to create a ClinCheck software model of your prescribed treatment. Upon approval of the ClinCheck treatment plan by your doctor, Align will produce and ship a series of customised aligners to your doctor.

The total number of aligners will vary depending on the complexity of your malocclusion and the doctor’s treatment plan. The aligners will be individually numbered and will be dispensed to you by your doctor with specific instructions for use.

Unless otherwise instructed by your doctor, you should wear your aligners for approximately 20 to 22 hours per day, removing them only to eat, drink, brush and floss. As directed by your doctor, you will switch to the next aligner in the series every two weeks or as directed by your doctor. Treatment duration varies depending on the complexity of your doctor’s prescription.

Some patients may require bonded aesthetic attachments and/ or the use of elastics during treatment to facilitate specific orthodontic movements. Patients may require additional impressions or intra-oral scans and/or refinement aligners after the initial series of aligners.

Benefits of Invisalign^® treatment

• Invisalign^® aligners offer an aesthetic alternative to conventional braces.
• Aligners are nearly invisible so many people won't realise you are in treatment.
• Treatment plans can be visualised through the ClinCheck software.
• Aligners do not have the metal wires or brackets associated with conventional braces.
• The wearing of aligners may improve oral hygiene habits during treatment.
• Invisalign^® patients may notice improved periodontal (gum) health during treatment.

Risks of Invisalign^® treatment

Like other orthodontic treatments, the use of Invisalign^® product(s) may involve some of the risks outlined below:

• Failure to wear the appliances for the required number of hours per day, not using the product as directed by your doctor, missing appointments, and erupting or atypically shaped teeth can lengthen the treatment time and affect the ability to achieve the desired results;
• Dental tenderness may be experienced after switching to the next aligner in the series;
• Gums, cheeks and lips may be scratched or irritated;
• Teeth may shift position after treatment. Consistent wearing of retainers at the end of treatment should reduce this tendency;
• 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 Invisalign^® products, or do not use proper oral hygiene and preventative maintenance;
• The aligners may temporarily affect speech and may result in a lisp, although any speech impediment caused by the Invisalign^® products should disappear within one or two weeks;
• Aligners may cause a temporary increase in salivation or mouth dryness and certain medications can heighten this effect;
• 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;
• Attachments may fall off and require replacement;
• Teeth may require interproximal recontouring or slenderising in order to create space needed for dental alignment to occur;
• The bite may change throughout the course of treatment and may result in temporary patient discomfort;
• 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;
• At the end of orthodontic treatment, the bite may require adjustment (“occlusal adjustment”);
• Atypically shaped, erupting and/or missing teeth may affect aligner adaptation and may affect the ability to achieve the desired results;
• Treatment of severe open bite, severe overjet, mixed dentition, and/or skeletally narrow jaw may require supplemental treatment in addition to aligner treatment;
• 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;
• 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;
• Aligners are not effective in the movement of dental implants;
• General medical conditions and use of medications can affect orthodontic treatment;
• Health of the bone and gums which support the teeth may be impaired or aggravated;
• Oral surgery may be necessary to correct crowding or severe jaw imbalances that are present prior to wearing the Invisalign^® product. If oral surgery is required, risks associated with anaesthesia and proper healing must be taken into account prior to treatment;
• 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;
• Existing dental restorations (e.g. crowns) may become dislodged and require re-cementation or in some instances, replacement;
• Short clinical crowns can pose appliance retention issues and inhibit tooth movement;
• 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;
• Product breakage is more likely in patients with severe crowding and/or multiple missing teeth;
• Orthodontic appliances or parts thereof may be accidentally swallowed or aspirated;
• In rare instances, problems may also occur in the jaw joint, causing joint pain, headaches or ear problems;
• Allergic reactions may occur;
• Teeth that are not at least partially covered by the aligner may undergo supraeruption;
• 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 dental procedures.

Additional aligners

After finishing your initial set of aligners, the cost of your first set of refinement/additional aligners will be covered by Wired Orthodontics. Any extra aligners after that may incur a charge of $650.00.

Risks of orthodontic treatment

All forms of medical and dental treatment including orthodontics have some risks and limitations. Fortunately in orthodontics, complications are infrequent and when they do occur, they are usually of only minor consequence.

1. Oral hygiene

Orthodontic appliances themselves do not cause tooth decay. However, issues like gum disease, tooth decay, and permanent markings (decalcification) can arise if orthodontic patients consume excessive sugar or do not brush their teeth regularly and thoroughly.

While these problems can occur even without orthodontic treatment, the risk is higher for those with braces. Therefore, maintaining excellent oral hygiene and diligent tooth brushing is crucial during orthodontic treatment.

2. Relapse

Teeth can shift position after orthodontic treatment, but consistent and long-term use of retainers can help minimise this tendency. Movement can occur at any time, whether or not orthodontic treatment was received, and is particularly common during late adolescence when facial bone growth slows. Front teeth are especially susceptible.

Throughout life, factors such as the eruption of wisdom teeth, growth or maturation changes, mouth breathing, playing musical instruments, and other oral habits can negatively affect the bite. In rare cases, significant tooth movement may require further treatment to achieve a satisfactory result.

3. Periodontal health

Orthodontic tooth movement can impact the health of the bone and gums supporting the teeth, especially if an existing condition is present, and occasionally even when no condition is apparent.

Generally, orthodontic treatment reduces the risk of tooth loss or gum infections caused by misalignment of the teeth or jaws. However, if bacterial plaque is not removed daily through proper oral hygiene, it can lead to gum inflammation and loss of supporting bone.

4. Root shortening

In some patients the length of the roots of the teeth may be shortened during orthodontic treatment. Some patients are prone to this happening, some are not. It is nearly impossible to predict susceptibility. Usually this shortening does not have significant consequences, but on very rare occasions it may become a threat to the longevity of the teeth involved.

5. Jaw joints

Occasionally, patients may experience pain or dysfunction in the jaw joints (TMJ), which can manifest as joint pain, headaches, or ear issues. These problems can arise with or without orthodontic treatment.

It is important to report any of these symptoms to the orthodontist. While some patients are more prone to TMJ issues than others, research has indicated that tooth movement during orthodontic treatment can be associated with the onset of TMJ problems.

6. Tooth vitality

a tooth may have been traumatised by a previous accident or a tooth may have decayed or have fillings which can cause damage to the nerve of the tooth. Orthodontic tooth movement in some cases aggravates these conditions and in rare instances may lead to loss of tooth vitality and discolouration of the tooth requiring root canal treatment and other dental treatment to restore the colour of the tooth.

7. Loose appliances and discomfort

Newly placed orthodontic appliances or damage to existing appliances can occasionally cause irritation or scratches to the gums, cheeks, or lips, especially if impacted by accidental blows to the mouth. You will receive guidance on how to minimise these effects. In rare cases, loose orthodontic appliances may be accidentally swallowed or inhaled.

If you notice any unusual symptoms or find that an appliance is broken or loose, you should inform your orthodontist immediately. Some tenderness after adjustments is normal and typically lasts between 24 to 48 hours, though the duration can vary depending on the patient and the specific procedure performed.

8. Atypical growth

Insufficient, excessive, or asymmetrical changes in the growth of the jaws may limit the orthodontist’s ability to achieve the desired result. If growth becomes disproportionate during orthodontic management, the treatment may be prolonged.

Growth changes that occur after orthodontic treatment may alter the quality of treatment results and may require further orthodontic treatment. In some cases of atypical growth, the bite may change so much that oral surgery is required to achieve the best possible result.

9. Treatment time

The total time required to complete treatment may exceed the estimate. Poor cooperation in wearing the appliance or the elastic for the required hours per day, poor oral hygiene, broken appliances, and missed appointments can lengthen the treatment time and affect the quality of results.

10. Cooperation

Cooperation throughout treatment is your best guarantee of achieving a pleasing smile and a good bite. Failure to cooperate could force the orthodontist to change the procedures and goals of your treatment. As a last resort, treatment might have to be suspended.

The consequences of early suspension may be worse than no treatment at all.

11. Complementary aesthetic dentistry

If your teeth vary from normal in the number, size, or shape of the teeth, achievement of the ideal result (e.g. complete closure of excessive space) may require restorative treatment. The most common types of complementary treatment are cosmetic bonding, crowns, and bridge restorative dental and periodontal therapy.

12. General health

General medical problems can affect orthodontic treatment. You should keep your orthodontist informed of any changes to your medical health.

13. Interproximal Reduction (IPR)

Some minor cosmetic reshaping, polishing, or IPR might be performed to improve the result cosmetically and to achieve a better bite. Although this procedure is done very carefully, there is an increased risk of tooth sensitivity, decay and/or gum complications if oral hygiene is not satisfactory.

14. Damage to existing crowns or restorations

Orthodontic treatment may compromise the integrity of existing dental crowns or restorations, potentially causing damage or breakage, necessitating their repair or replacement.

Informed consent

I have been given adequate time to read and have read the preceding information describing orthodontic treatment with Invisalign^® 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 Invisalign^®`s product with my doctor from whom I intend to receive treatment. I understand that I should only use the Invisalign^® product after consultation and prescription from an Invisalign^® trained doctor, and I hereby consent to orthodontic treatment with Invisalign^®’s product that has been prescribed by my doctor.

Due to the fact that orthodontics is not an exact science, I acknowledge that my doctor and Align Technology, Inc. (“Align”) have not and cannot make any guarantees or assurances concerning the outcome of my treatment. I understand that Align is not a provider of medical, dental or health care services and does not and cannot practise medicine, dentistry, or give medical advice. No assurances or guarantees of any kind have been made to me by my doctor or Align, its representatives, successors, assigns, and agents concerning any specific outcome of my treatment.

I authorise my doctor to release my medical records, including, but not be limited to, radiographs (x-rays), reports, charts, medical history, photographs, findings, plaster models or impressions or intraoral scans of teeth, prescriptions, diagnosis, medical testing, test results, billing, and other treatment records in my doctor’s possession (“Medical Records”) (i) to other licensed dentists or and organisations employing licensed dentists and orthodontists and to Align, its representatives, employees, successors, assigns, and agents for the purposes of investigating and reviewing my medical history as it pertains to orthodontic treatment with product(s) from Align and (ii) for educational and research purposes.

I understand that use of my Medical Records may result in disclosure of my “individually identifiable health information” as defined by the Health Insurance Portability and Accountability Act (“HIPAA”). I hereby consent to the disclosure(s) as set forth above. I will not, nor shall anyone on my behalf seek legal, equitable, or monetary damages or remedies for such disclosure. I acknowledge that use of my Medical Records is without compensation and that I will not nor shall anyone on my behalf have any right of approval, claim of compensation, or seek or obtain legal, equitable or monetary damages or remedies arising out of any use such that comply with the terms of this Consent.

A photostatic copy 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.

I hereby authorise Dr Sep Tabatabaee to carry out orthodontic treatment and any other related procedures deemed necessary including radiographs, for the welfare and treatment of my smile.

I have had the proposed treatment plan explained to me along with the risks of orthodontic treatment explained to me, and been given a document that outlines these risks.

I confirm that the risks attached to the proposed treatment have been explained to me by my practitioner and that I fully understand those risks and have determined to proceed with treatment.

I will make every effort to attend appointments, and wear the orthodontic appliances as instructed.

I understand that any more than 3 attendance failures to appointments without at least 48 hours’ notice will incur a no-show fee of $70.

FINANCIAL AGREEMENT

I agree to pay the fees for treatment, as outlined below:

Payment plan:

I agree to follow all of Wired Orthodontics policies and procedures and acknowledge that these will change from time to time.

I agree to the use of the records obtained by the orthodontist including photographic and X-rays images, and orthodontic models for demonstration, display or social media.

Some minor cosmetic reshaping/polishing might be performed to improve the result cosmetically.

I understand that the orthodontist does not do fillings or other general dental work. I will continue to attend for regular dental examinations, and treatment as required during the course of the orthodontic treatment.

I understand that retainers follow my orthodontic treatment. Failure to wear these as prescribed may lead to tooth movement. Fees could apply if re-treatment is needed to correct this. I understand that the fees cover 2 years of retainer visits; if the retainer is lost or broken a fee for the new retainer will be charged.

I acknowledge that orthodontic appliances will not be removed if there is an outstanding account

I acknowledge that late fees will be incurred on overdue invoices, our invoices are 30-day invoices. To avoid a late payment fee of $15 please pay new charges by the due date.

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