Invisalign Informed Consent Form

Your doctor has recommended the Invisalign® 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 Invisalign aligners) has limitations and potential risks that you should consider before undergoing treatment.

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 products combine 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 customized Invisalign aligners is produced specifically for your treatment.

Procedure

You may undergo a routine orthodontic pre-treatment examination including radiographs (x-rays) and photographs. Your doctor will take impressions 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 customized 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, brush and floss. As directed by your doctor, you will switch to the next aligner in the series every two to three weeks. Treatment duration varies depending on the complexity of your doctor’s prescription. Unless instructed otherwise, you should follow up with your doctor at a minimum of every 6 to 8 weeks. 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 and/or refinement aligners after the initial series of aligners.

Benefits

• Invisalign® aligners offer an esthetic alternative to conventional braces.
• Aligners are nearly invisible so many people won’t realize you are in treatment.
• Treatment plans can be visualized through the ClinCheck® 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.
• The wearing of aligners may improve oral hygiene habits during treatment.
• Invisalign patients may notice improved periodontal (gum) health during treatment.

Risks And Inconveniences

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

(i) 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;

(ii) Dental tenderness may be experienced after switching to the next aligner in the series;

(iii) Gums, cheeks and lips may be scratched or irritated;

(iv) Teeth may shift position after treatment. Consistent wearing of retainers at the end of treatment should reduce this tendency;

(v) 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;

(vi) 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;

(vii) Aligners may cause a temporary increase in salivation or mouth dryness and certain medications can heighten this effect;

(viii) 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;

(ix) Teeth may require interproximal recontouring or slenderizing in order to create space needed for dental alignment to occur;

(x) The bite may change throughout the course of treatment and may result in temporary patient discomfort.

(xi) At the end of orthodontic treatment, the bite may require adjustment (“occlusal adjustment”).

(xii) 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.

(xiii) 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.

(xiv) Aligners are not effective in the movement of dental implants.

(xv) General medical conditions and use of medications can affect orthodontic treatment;

(xvi) Health of the bone and gums which support the teeth may be impaired or aggravated;

(xvii) 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 anesthesia and proper healing must be taken into account prior to treatment;

(xviii) A tooth that has been previously traumatized, 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;

(xix) Existing dental restorations (e.g. crowns) may become dislodged and require re-cementation or in some instances, replacement;

(xx) Short clinical crowns can pose appliance retention issues and inhibit tooth movement;

(xxi) 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;

(xxii) Product breakage is more likely in patients with severe crowding and/or multiple missing teeth;

(xxiii) Orthodontic appliances or parts thereof may be accidentally swallowed or aspirated;

(xxiv) In rare instances, problems may also occur in the jaw joint, causing joint pain, headaches or ear problems;

(xxv) Allergic reactions may occur; and

(xxvi) Teeth that are not at least partially covered by the aligner may undergo supraeruption;

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® products with my doctor from whom I intend to receive treatment. I understand that I should only use the Invisalign products after consultation and prescription from an Invisalign trained doctor, and I hereby consent to orthodontic treatment with Invisalign products that have 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 practice 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 authorize 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 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 orthodontists and organizations 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.

Congratulations, you are on your way to a beautiful new smile. We hope you are as excited about this new journey as we are. Our team is dedicated to providing exceptional patient care to ensure that your Invisalign treatment progresses as smoothly as possible. It is imperative that you understand the procedures involved in your treatment. Please read this worksheet carefully and make sure to clarify any questions you may have regarding your Invisalign treatment with our team.

The Start of Treatment:

• Invisalign scan will take all the photos and x-rays we have already taken of you will be gathered for Drs. Shaw to properly diagnose your treatment and start the process of aligner fabrication. The majority of patients have a second scan taken towards the end of their first set of aligners in order to fabricate a second set of detailing trays. Thus, your individual treatment time is an estimate based on Dr. Shaw’s surmise at your new patient exam and is not based on the number of aligners your receive in your first set.
• The process of scan submission, communication, and finally aligner fabrication takes 4-6 weeks. We will call you when your aligners have arrived in our office to schedule your Invisalign delivery appointment.
• At your next appointment attachments will be bonded to your teeth as shown below, with placement varying on your specific case and movements. Please plan for your initial delivery appointment to take no more than an hour. Attachments are not visible to the naked eye and act as “grippers” to help with tooth movement. Your general dentist should not remove the tooth-colored attachments.

Treatment Progress:

• The most important variable for the success of your Invisalign treatment is your compliance to wear the aligners as instructed. Aligners need to be worn at minimum 22 hours per day, without exception. This includes faithful wear of rubber bands, if indicated, during treatment.
• You will wear each Aligner in the series for 1 week (or as prescribed by Dr.Shaw)
• After a week period, provided there are no air-gaps between the Aligner and the biting edges of your teeth, remove and clean your Aligners and put them into your Ziplock bag to be saved; you can now change into the next set of Aligners
• Aligners should feel “loose and comfortable” before moving-on to the next Aligner

Additionally, your aligners should have no visible space seen between the edge of the teeth, and the aligner itself. The aligners should always fit tight over the teeth so no space is visible at the edge of the teeth. If a gap exists, aligner chewies should be used faithfully until the aligner fits properly.

Do not transition to your next aligner until all gaps between the teeth and the aligner are resolved.

To use the chewie, bite down and hold in the area where the aligner needs to fit better for 5 seconds, then release. Repeat this process for 10 minutes at a time, up to three times per day, until the gap is reduced.

**If you have a history of TMJ, do not use the chewies, but instead use steady figure pressure to push the aligner in place instead, always making sure not to put pressure on your lower jaw if the problem is on the lower teeth.

During treatment, we may polish in between certain teeth in order to alleviate crowding. This process will not hurt you or your enamel and may be necessary in order to achieve detailed and optimal results.

Storing Your Aligners

• You will be given a Blue Case (Current Aligner): Use this case to store your Active Aligners when they are not in your mouth
• Keep all of your Aligners; store the rest of the “Old Aligners” in a Ziploc bag until the end of treatment
• On the bottom of each Aligner there is a number, which will help you keep track of the Aligner you are presently in: Ex. U-01: Upper Arch Aligner #1 OR L-01: Lower Arch Aligner #1
• Always store your Aligners in their case when not being worn to avoid loss
  • Please do not put the Aligners in a napkin, too frequently they will get thrown away & Keep them away from pets, they love to chew on them
• Aligners should be stored in a cool, dry place
• Never leave Aligners in any location warmer than your mouth (i.e. boiling water)

Brushing and Flossing

Now that you have your Invisalign aligners, you must be sure to brush and floss better than ever before.

• Brushing Instructions: Brush your teeth, gums, cheeks, roof of mouth and tongue with a soft-bristled toothbrush, in circular motions after you wake up in the morning, every time you get done eating or drinking anything other than water & before you go to bed.
• Flossing Instructions: Floss between teeth 1x/day; flossing helps remove the plaque from between the teeth and under the gum line.

***It is absolutely essential that you continue regular visits to your family dentist for checkups and cleanings throughout your orthodontic treatment!

Cleaning Your Aligners

• Before placing your Aligners in your mouth please be sure to brush and floss your teeth
• Aligners should be cleaned using any kind of denture cleaner tablets when they are removed. DO NOT USE TOOTHPASTE OR SOAK IN LISTERINE.

Appointments

• Keep your scheduled appointments, this is the only way we can ensure your treatment is progressing as planned
• We will give you 6-8 weeks worth of aligners at each appointment (ie. 6-8 aligner bags, marked with the dates they should be changed out).

Dental Work During Treatment

• You should consult our office prior to having any dental restorations done, as this may affect the fit of the Aligners

Foods to Avoid

Don't worry, since you have chosen to have Invisalign aligners you have the luxury of eating whatever you want. However, it is important that you do not eat or drink anything other than water while your aligners are on your teeth.

Emergency Care

While we recognize that orthodontic “emergencies” are not life-and-death situations, we also understand that situations may occur that cause discomfort. We provide the information below to help you prevent those types of emergencies and also to answer some of the most common questions regarding these special situations.

• Loose Teeth: If your teeth being feeling loose, don’t worry, it’s normal! Your braces must first loosen your teeth to move them in the right position. Once your teeth have been repositioned, they will no longer be loose.
• Broken Attachments: It is possible that the attachments can come off of your teeth. If they do please contact our office as soon as possible to set an appointment to have them replaced.
• Lost/Broken Aligners: If your aligner becomes lost, cracks, etc. after one week of wear, it may be OK to move into your next aligner. However, please call our office to confirm if this is OK.
• Rough Areas: If you have a rough spot on your aligner, gently use an emery board to smooth out the area.

Please contact our office at 972-899-1465 or info@Shaworthodontics.com should you need any kind of orthodontic repair & we will get you in as soon as possible. Please note emergency appointments can only be performed at designated hours each day. It is unfair to our regularly scheduled patients to have their appointments affected by an “add in” emergency. If you have an emergency after hours or on non-patient day you can text us at 954-980-7877 and our dental assistant on duty will return your message as soon as possible.

I have read and understand the procedures necessary for the success of my Invisalign treatment.