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Dentistry On 66

Invisalign Form

PATIENT’S INFORMED CONSENT AND
AGREEMENT REGARDING INVISALIGN®
ORTHODONTIC TREATMENT
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;
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.
(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) Af 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 the 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.