Notice to treating office: This form is to be signed by your Invisalign® patients prior to treatment and kept for your
records
and should not be sent to Align Technology, Inc.
INFORMED CONSENT AND AGREEMENT
FOR THE INVISALIGN PATIENT
Align Technology, Inc.
(888) 822-5446
[Link]
INFORMED CONSENT AND AGREEMENT FOR THE INVISALIGN PATIENT 1 of 3
PATIENT’S INFORMED CONSENT AND BENEFITS
AGREEMENT REGARDING INVISALIGN® t *OWJTBMJHO® aligners offer an esthetic alternative to conventional
ORTHODONTIC TREATMENT braces.
Your doctor has recommended the Invisalign® system for your t "MJHOFSTBSFOFBSMZJOWJTJCMFTPNBOZQFPQMFXPOUSFBMJ[FZPV
orthodontic treatment. Although orthodontic treatment can are in treatment.
lead to a healthier and more attractive smile, you should also t 5SFBUNFOUQMBOTDBOCFWJTVBMJ[FEUISPVHIUIF$MJO$IFDL®
be aware that any orthodontic treatment (including orthodontic software.
treatment with Invisalign aligners) has limitations and potential t "MJHOFSTBMMPXGPSOPSNBMCSVTIJOHBOEGMPTTJOHUBTLTUIBUBSF
risks that you should consider before undergoing treatment. generally impaired by conventional braces.
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DEVICE DESCRIPTION
with conventional braces.
Invisalign® aligners, developed by Align Technology, Inc.
t 5IFXFBSJOHPGBMJHOFSTNBZJNQSPWFPSBMIZHJFOFIBCJUT
(“Align”) consist of a series of clear plastic, removable
during treatment.
appliances that move your teeth in small increments. Invisalign
t *OWJTBMJHOQBUJFOUTNBZOPUJDFJNQSPWFEQFSJPEPOUBM HVN
products combine your doctor’s diagnosis and prescription
health during treatment.
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 RISKS AND INCONVENIENCES
treatment plan developed by your doctor, a series of customized Like other orthodontic treatments, the use of Invisalign®
Invisalign aligners is produced specifically for your treatment. product(s) may involve some of the risks outlined below:
(i) Failure to wear the appliances for the required number of
PROCEDURE
hours per day, not using the product as directed by your doctor,
You may undergo a routine orthodontic pre-treatment
missing appointments, and erupting or atypically shaped teeth
examination including radiographs (x-rays) and photographs.
can lengthen the treatment time and affect the ability to achieve
Your doctor will take impressions or intra-oral scans of your teeth
the desired results;
and send them along with a prescription to the Align laboratory.
Align technicians will follow your doctor’s prescription to create (ii) Dental tenderness may be experienced after switching to the
®
a ClinCheck software model of your prescribed treatment. Upon next aligner in the series;
approval of the ClinCheck treatment plan by your doctor, Align
(iii) Gums, cheeks and lips may be scratched or irritated;
will produce and ship a series of customized aligners to your
doctor. The total number of aligners will vary depending on the (iv) Teeth may shift position after treatment. Consistent wearing
complexity of your malocclusion and the doctor’s treatment plan. of retainers at the end of treatment should reduce this tendency;
The aligners will be individually numbered and will be dispensed
to you by your doctor with specific instructions for use. Unless (v) Tooth decay, periodontal disease, inflammation of the
otherwise instructed by your doctor, you should wear your gums or permanent markings (e.g. decalcification) may occur if
aligners for approximately 20 to 22 hours per day, removing them patients consume foods or beverages containing sugar, do not
only to eat, brush and floss. As directed by your doctor, you will brush and floss their teeth properly before wearing the Invisalign
switch to the next aligner in the series every two to three weeks. products, or do not use proper oral hygiene and preventative
Treatment duration varies depending on the complexity of your maintenance;
doctor’s prescription. Unless instructed otherwise, you should (vi) The aligners may temporarily affect speech and may result in
follow up with your doctor at a minimum of every 6 to 8 weeks. a lisp, although any speech impediment caused by the Invisalign
Some patients may require bonded aesthetic attachments products should disappear within one or two weeks;
and/or the use of elastics during treatment to facilitate specific
orthodontic movements. Patients may require additional (vii) Aligners may cause a temporary increase in salivation or
impressions, or intra-oral scans, and/or refinement aligners mouth dryness and certain medications can heighten this effect;
after the initial series of aligners.
Align Technology, Inc.
(888) 822-5446
[Link]
INFORMED CONSENT AND AGREEMENT FOR THE INVISALIGN PATIENT 2 of 3
(viii) Attachments may be bonded to one or more teeth during (xxi) Oral surgery may be necessary to correct crowding or
the course of treatment to facilitate tooth movement and/or severe jaw imbalances that are present prior to wearing the
appliance retention. These will be removed after treatment is Invisalign product. If oral surgery is required, risks associated with
completed; anesthesia and proper healing must be taken into account prior
to treatment;
(ix) Attachments may fall off and require replacement.
(xxii) A tooth that has been previously traumatized, or
(x) Teeth may require interproximal recontouring or slenderizing
significantly restored may be aggravated. In rare instances
in order to create space needed for dental alignment to occur;
the useful life of the tooth may be reduced, the tooth may
(xi) The bite may change throughout the course of treatment require additional dental treatment such as endodontic and/or
and may result in temporary patient discomfort. additional restorative work and the tooth may be lost;
(xii) In rare instances, slight superficial wear of the aligner may (xxiii) Existing dental restorations (e.g. crowns) may become
occur where patients may be grinding their teeth or where the dislodged and require re-cementation or in some instances,
teeth may be rubbing and is generally not a problem as overall replacement;
aligner integrity and strength remain intact.
(xxiv) Short clinical crowns can pose appliance retention issues
(xiii) At the end of orthodontic treatment, the bite may require and inhibit tooth movement;
adjustment (“occlusal adjustment”).
(xxv) The length of the roots of the teeth may be shortened
(xiv) Atypically-shaped, erupting, and/or missing teeth may affect during orthodontic treatment and may become a threat to the
aligner adaptation and may affect the ability to achieve the useful life of teeth;
desired results.
(xxvi) Product breakage is more likely in patients with severe
(xv) Treatment of severe open bite, severe overjet, mixed crowding and/or multiple missing teeth;
dentition, and/or skeletally narrow jaw may require supplemental
(xxvii) Orthodontic appliances or parts thereof may be
treatment in addition to aligner treatment.
accidentally swallowed or aspirated;
(xvi) Supplemental orthodontic treatment, including the use
(xxviii) In rare instances, problems may also occur in the jaw joint,
of bonded buttons, orthodontic elastics, auxiliary appliances/
causing joint pain, headaches or ear problems;
dental devices (e.g. temporary anchorage devices, sectional
fixed appliances), and/or restorative dental procedures may be (xxix) Allergic reactions may occur; and
needed for more complicated treatment plans where aligners
(xxx) Teeth that are not at least partially covered by the aligner
alone may not be adequate to achieve the desired outcome.
may undergo supraeruption;
(xvii) Teeth which have been overlapped for long periods of
(xxxi) In rare instances patients with hereditary angioedema
time may be missing the gingival tissue below the interproximal
(HAE), a genetic disorder, may experience rapid local swelling of
contact once the teeth are aligned, leading to the appearance of
subcutaneous tissues including the larynx. HAE may be triggered
a “black triangle” space.
by mild stimuli including dental procedures.
(xviii) Aligners are not effective in the movement of dental
implants.
(xix) General medical conditions and use of medications can
affect orthodontic treatment;
(xx) Health of the bone and gums which support the teeth may
be impaired or aggravated;
Align Technology, Inc.
(888) 822-5446
[Link]
INFORMED CONSENT AND AGREEMENT FOR THE INVISALIGN PATIENT 3 of 3
INFORMED CONSENT impressions of teeth, or intra-oral scans, prescriptions,
I have been given adequate time to read and have read the diagnosis, medical testing, test results, billing, and other
preceding information describing orthodontic treatment with treatment records in my doctor’s possession (“Medical Records”)
Invisalign aligners. I understand the benefits, risks, alternatives (i) to other licensed dentists or orthodontists and organizations
and inconveniences associated with treatment as well as the employing licensed dentists and orthodontists and to Align, its
option of no treatment. I have been sufficiently informed and representatives, employees, successors, assigns, and agents for
have had the opportunity to ask questions and discuss concerns the purposes of investigating and reviewing my medical history
®
about orthodontic treatment with Invisalign products with my as it pertains to orthodontic treatment with product(s) from Align
doctor from whom I intend to receive treatment. I understand and (ii) for educational and research purposes.
that I should only use the Invisalign products after consultation
I understand that use of my Medical Records may result in
and prescription from an Invisalign trained doctor, and I hereby
disclosure of my “individually identifiable health information”
consent to orthodontic treatment with Invisalign products that
as defined by the Health Insurance Portability and Accountability
have been prescribed by my doctor.
Act (“HIPAA”). I hereby consent to the disclosure(s) as set forth
Due to the fact that orthodontics is not an exact science, I above. I will not, nor shall anyone on my behalf seek legal,
acknowledge that my doctor and Align Technology, Inc. (“Align”) equitable or monetary damages or remedies for such disclosure.
have not and cannot make any guarantees or assurances I acknowledge that use of my Medical Records is without
concerning the outcome of my treatment. I understand that compensation and that I will not nor shall anyone on my behalf
Align is not a provider of medical, dental or health care services have any right of approval, claim of compensation, or seek or
and does not and cannot practice medicine, dentistry or give obtain legal, equitable or monetary damages or remedies arising
medical advice. No assurances or guarantees of any kind have out of any use such that comply with the terms of this Consent.
been made to me by my doctor or Align, its representatives,
A photostatic copy of this Consent shall be considered as
successors, assigns, and agents concerning any specific outcome
effective and valid as an original. I have read, understand and
of my treatment.
agree to the terms set forth in this Consent as indicated by my
I authorize my doctor to release my medical records, including, signature below.
but not be limited to, radiographs (x-rays), reports, charts,
medical history, photographs, findings, plaster models,
Signature Witness
Print Name Print Name
Address Signature of Parent/Guardian:
City, State, Zip
If signatory is under 21, the parent or legal Guardian must also sign to signify agreement.
Date
Align Technology, Inc.
(888) 822-5446
[Link]
© 2013 Align Technology, Inc. All rights reserved. | F16015 Rev E