AACO REFERENCE MATERIAL: FOR USE BY ACTIVE MEMBERS

AACO REFERENCE MATERIAL: FOR USE BY ACTIVE MEMBERS OF AACO DURING

PERIOD OF AACO MEMBERSHIP ONLY. THIS FORM CONTAINS PROPRIETARY

MATERIALS AND MAY NOT BE USED BY NON-AACO MEMBERS.

INFORMED CONSENT TEMPLATE FOR USE IN CONNECTION WITH PATIENTS

UNDERGOING CLEAR ALIGNER ORTHODONTIC TREATMENT

AACO MAKES NO WARRANTY OR REPRESENTATION AS TO THE ADVISABILITY OR ENFORCEABILITY

OF ANY PARITUCLAR PROVISION CONTAINED IN THIS INFORMED CONSENT TEMPLATE.

YOU SHOULD CONSULT WITH A LAWYER FAMILIAR WITH THE LAWS OF THE RELEVANT

JURISDICTION OR JURISDICTIONS BEFORE USING THIS INFORMED CONSENT TEMPLATE.

FOR USE BY DOCTORS ONLY

The eectiveness of your orthodontic treatment depends on your cooperation with your doctor. An informed

and cooperative patient who carefully follows his or her doctor’s prescribed orthodontic treatment plan will have

the best chance to achieve positive results.

Your doctor has recommended that you use a clear aligner orthodontic treatment system. Although you may

already understand the obvious potential benets of using clear aligner treatment, i.e., a beautiful, healthy smile,

it is important that you consider that, as is the case with all medical treatments and procedures, orthodontic

treatment has limitations, risks, and inconveniences, and, occasionally, such risks may warrant foregoing

treatment altogether. Prior to treatment, speak with your doctor about the potential risks of using a clear

aligner orthodontic treatment system and available orthodontic alternatives, including the option of having no

treatment at all.

Please read this information carefully. Be sure to ask your doctor about anything that you do not completely

understand, and make sure that you know exactly what is required of you as the patient (or as the

parent/guardian of a patient) during treatment.

INFORMED CONSENT FORM FOR PATIENTS

UNDERGOING CLEAR ALIGNER ORTHODONTIC TREATMENT

About Clear Aligner Treatment

Clear aligner orthodontic treatment consists of a

series of clear plastic, removable appliances worn

by the patient. The liners are designed to move your

teeth in small increments to improve bite function

and/or esthetic appearance.

Clear aligner orthodontic treatment combines your

doctor’s diagnosis and prescription with specialized

technology to formulate a treatment plan that

species the desired movements of your teeth.

Once your doctor has developed your treatment

plan, a series of customized aligners will be

fabricated specically for you.

Procedure

Your doctor may rst conduct a regular exam and take

x-rays and photographs of your teeth. Impressions/

Scans of your teeth will be taken by your doctor and

sent with a prescription to the laboratory of your

clear aligner treatment system’s manufacturer (the

“Manufacturer”), where technicians will develop your

treatment plan in accordance with your doctor’s

prescription. Based on the treatment plan, a series

of custom-made aligners, designed specically for

you, will be created and sent to your doctor. The

total number of aligners will vary depending on the

complexity of your malocclusion (misaligned bite)

and treatment plan prescribed by your doctor.

Your doctor will provide you with the aligners in

accordance with the treatment plan and give you

specic instructions for their use. Unless your doctor

instructs otherwise, you MUST wear your aligners at

least 22 hours per day, removing them only to eat,

brush, and oss.

Your doctor will inform you when it is time to switch

aligners. Generally speaking, you will wear a given

set of aligners for about two to three weeks before

switching to the next set in the series. The duration

of your treatment plan depends on the complexity of

your doctor’s prescription.

Unless your doctor instructs otherwise, you should

follow up with your doctor at least every four to

six weeks. Missing and cancelling appointments

will negatively impact your treatment and may

result in unwanted teeth shifting. If you miss a

scheduled appointment, your doctor will have no

responsibility for unwanted teeth shifting and/or

incomplete treatment.

Unwanted teeth shifting and/or incomplete

treatment is a risk you assume if you miss a

scheduled appointment.

Benets of Clear Aligner Treatment

The clear aligner treatment system is intended

to provide the end benets of traditional “wired”

orthodontic treatment, such as straight teeth and

Patient must initial for consent.

INFORMED CONSENT FORM FOR PATIENTS

UNDERGOING CLEAR ALIGNER ORTHODONTIC TREATMENT

improved bite function, as well as the following

benets that are only available when going wireless:

• Clear aligners oer an esthetic alternative to

conventional braces.

• The aligners are practically invisible.

• Aligners are removable, allowing you to eat, drink,

brush, and oss without diculty.

• There are no cuts or abrasions from metal wires

or brackets, so clear aligners are generally more

comfortable than traditional braces.

In addition, the wearing of clear aligners may improve

oral hygiene habits during treatment, and you may

notice improved overall gum health.

Possible Risks and Inconveniences

As with other orthodontic treatments, clear aligner

treatment product(s) may carry some of the following

risks and inconveniences:

• Treatment time may exceed your doctor’s

estimates. Poor compliance with your doctor’s

instructions, not wearing aligners the required

number of hours per day, missed appointments,

excessive bone growth, poor oral hygiene, and

broken appliances can lengthen treatment time,

increase your costs, and aect the quality of

your results.

• Erupting or atypically shaped teeth can lengthen

the treatment time and aect the ability to achieve

the desired results.

• Dental tenderness may be experienced after

switching aligners.

• Sores and irritation of the soft tissue of the mouth

(i.e., gums, cheeks, tongue, and lips) are possible

but rarely occur due to wearing aligners.

• Teeth may shift position after treatment. Following

your doctor’s post-treatment retention plan, which

will include consistent wearing of retainers at the

end of treatment, should reduce this tendency.

• The aligners may temporarily aect speech,

although any speech impediment caused by the

clear aligner treatment products should disappear

within one or two weeks.

• You may experience a temporary increase

in salivation or mouth dryness and certain

medications can heighten this eect.

• 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).

• Tooth decay, periodontal disease, inammation

of the gums, or permanent markings may occur if

patients consume food or beverages containing

sugar, do not brush and oss their teeth properly

before wearing the clear aligner treatment

products, or do not use proper oral hygiene and

preventative maintenance.

• Teeth may require interproximal recontouring or

slenderizing in order to create space needed for

dental alignment to occur.

• Your bite may change throughout treatment,

which may cause you to experience

temporary discomfort.

• Additional orthodontic treatment, including

the use of bonded buttons, orthodontic

elastics, auxiliary appliances/dental devices

(e.g., temporary anchorage devices or sectional

xed 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 (there

may be an additional cost to you if you require s

uch procedures).

• You may require additional impressions and/or

renement aligners after the initial series

of aligners.

• 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 eective in the movement of

dental implants.

• At the end of orthodontic treatment, the bite may

require adjustment (“occlusal adjustment”).

Patient must initial for consent.

INFORMED CONSENT FORM FOR PATIENTS

UNDERGOING CLEAR ALIGNER ORTHODONTIC TREATMENT

• General medical conditions and use of

medications can aect orthodontic treatment.

• Allergic reactions may occur.

• The 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 clear aligner product(s) (if oral surgery

is required, risks associated with anesthesia and

proper healing must be taken into account prior

to treatment).

• Previously traumatized or signicantly restored

teeth 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/or the tooth may be lost.

• Existing dental restorations, such as crowns and

bridges, may become dislodged and require

re-cementation or, in some instances, replacement.

• Short clinical crowns can pose appliance retention

issues and inhibit tooth movement.

• Root resorption (shortening) can occur during

treatment. Shortened roots are not a problem

under healthy conditions. In rare cases, however,

root resorption can result in loss of teeth (there

is no way to foresee if this will occur during your

treatment and nothing can be done to prevent it).

• In cases of multiple missing teeth, it is more likely

that the aligner may break (if this happens, contact

your doctor immediately to replace it).

• Because orthodontic appliances are worn in the

mouth, accidentally swallowing or aspirating the

aligner may occur.

• In rare instances, problems may occur in the jaw

joint, causing joint pain, discomfort, headaches,

or ear problems (if you experience any of these

symptoms, contact your doctor immediately).

• Teeth that are not at least partially covered by the

aligner may undergo supra-eruption (i.e., come

out of the gums more than other teeth).

Patient Commitment

Your commitment is critical to achieving the best

possible results with the clear aligner treatment

system. It is absolutely crucial that you wear your

aligners at least 22 hours per day, every day,

except when eating, brushing, and ossing. Failure

to do so will negatively impact treatment and

prevent you from achieving the desired results.

Smile Retention

Due to the tendency of teeth to shift in the human

dentition, you can expect that your teeth will naturally

begin to shift back to their original position once your

prescribed course of aligners is complete. For this

reason, you MUST wear the retainer(s) provided

by your doctor for life. This is the most critical part

of your treatment and is essential to maintaining

your results.

Upon completion of your clear aligner treatment,

lingual bars may be installed. These are rigid metal

reinforcements placed behind your teeth to prevent

them from moving.

In addition, all patients will need to wear retainers

indenitely. Retainers are to be worn full time over

your lingual bar, at least 22 hours a day, for the rst

two weeks of use. After a few months of gradually

wearing the retainers less frequently throughout

the day, you may, with permission from your doctor,

begin wearing your retainers at night only.

Retainers should be cleaned with a toothbrush and

water every time you brush your teeth, and should be

replaced every nine to 12 months due to cleanliness

and rmness issues. You must clean around your

lingual bar carefully and diligently every night to

prevent plaque and gum disease.

If either your lingual bar or retainer is lost or broken

it should be replaced immediately. If your lingual bar

breaks, you MUST immediately begin wearing your

last set of aligners until it is replaced to prevent your

teeth from shifting.

Patient must initial for consent.

INFORMED CONSENT FORM FOR PATIENTS

UNDERGOING CLEAR ALIGNER ORTHODONTIC TREATMENT

Fees

Payment of your bills is considered part of your

treatment, and all charges incurred are your

responsibility. Please note that our relationship is

with you, the patient, not your insurance company.

Depending on your insurance company, we may, as

a courtesy, bill your insurer directly; however, you are

responsible for any co-payment and the portion that

your insurance does not cover.

Please keep in mind that insurance is strictly an

estimate not a guarantee of payment. Our practice is

committed to providing the best treatment for our

patients and we charge what is usual and customary.

Understand that clear aligner treatment involves

signicantly more steps and higher laboratory fees

than traditional braces, and you are responsible for

payment regardless of any insurance company’s

arbitrary determination of usual and customary

rates based on traditional braces. Our oce will

cooperate fully with the regulations and requests of

those specic insurance companies for which we are

providers. However, we will not enter into a dispute

with your insurance company over any claim.

If your treatment time is extended and/or the

treatment plan changes beyond the estimated time

due to your choice, or specically because of missed

appointments, and/or failure to comply with your

doctor’s instructions, there may be additional fees

until completion of your treatment.

Any patient who cancels or breaks a scheduled

appointment on less than 24 hours notice may incur a

cancellation fee.

If you do not comply with your doctor’s

instructions and, as a result, your aligners do not

conform to your teeth, there will be an additional

charge to get more aligners fabricated for correction.

Old aligners will be discarded after one year from

your last appointment if you fail to continue your

treatment and new impressions will be required

to restart.

If supplemental orthodontic treatment or additional

cosmetic procedures (e.g., crowns or veneers) are

necessary to complete treatment, there may be an

additional cost to you if you require such procedures.

If for any reason you fail to pay while in treatment,

and, after receiving adequate notice of your failure

to pay, your account remains in arrears, treatment

may be discontinued until your balance is paid, at

which time treatment will resume. Unless otherwise

agreed, acceptance of late payment, partial payment,

or nonpayment shall not constitute a waiver of our

entitlement to have all bills paid in full and on time;

nor shall such acceptance constitute a waiver of any

legal rights and remedies available to us.

Patient must initial for consent.

Informed Consent and Agreement

I have been given adequate time to read and have read the preceding information describing clear aligner

orthodontic treatment. I have discussed with my doctor and understand the benets, risks, alternatives

and inconveniences, required patient commitment and smile retention practices, and fees associated

with treatment as well as the option of no treatment. I have been suciently informed and have had the

opportunity to ask questions and discuss concerns about clear aligner orthodontic treatment products

with my doctor from whom I intend to receive treatment. I understand that I should only use clear aligner

orthodontic treatment products after consultation and prescription from a trained doctor, and I hereby

consent to orthodontic treatment with clear aligner treatment products that have been prescribed by

my doctor.

INFORMED CONSENT FORM FOR PATIENTS

UNDERGOING CLEAR ALIGNER ORTHODONTIC TREATMENT

I agree to follow my doctor’s treatment exactly as my doctor prescribes and provides it for me, and I understand

that any questions, concerns, or complaints I have regarding my treatment must be communicated to my doctor

as soon as they arise.

Due to the fact that orthodontics is not an exact science, I acknowledge that my doctor and the

Manufacturer have not and cannot make any guarantees or assurances concerning the outcome of my

treatment. I understand that the Manufacturer 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 the Manufacturer, its representatives, successors, assigns, and

agents concerning any specic 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, ndings, 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 the Manufacturer, 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

Manufacturer’s product(s) and [ii] for educational and research purposes.

I understand that use of my Medical Records may result in disclosure of my “individually identiable health

information” as dened 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 eective and valid as an original. I have read,

understand, and agree to the terms set forth in this Informed Consent and Agreement as indicated by my

signature below.

Patient Name

Signature of Patient or Parent/Guardian (if patient is a minor) Date Time

Signature of Dentist/Orthodontist

Witness Name

Witness Signature Date Time