Informed Consent and Agreement for the Invisalign Patient The Invisalign System is a new orthodontic treatment that can straighten your teeth while avoiding the compromised appearance associated with wearing the traditional braces. Developed specifically for patients with adult dentition who are no longer experiencing significant jaw growth, the Invisalign System is virtually invisible and it’s removable. The Following information, with the exception of the “Device description” and “Procedure “ sections, is routinely supplied to anyone considering orthodontic treatment. Although orthodontic treatment can provide the benefits of healthy teeth and attractive smile, you should also be aware that orthodontic treatment has limitations and potential risks that should be considered before undergoing treatment. Device Description The Invisalign System, developed by Align Technology, consists of a series of clear polymer; removable appliances (aligners) that move your teeth in small increments from their original state to a more ideal treated state. Some patients may also require bonded aesthetic attachments (small, tooth-colored, dental composites) and/or elastics on their teeth to facilitate specific dental movements. The Invisalign System combines your orthodontist’s diagnosis and treatment plan with sophisticated computer graphics technology to develop your series of customized aligners. You typically wear the aligners in pairs, one on your upper dental arch and one on your lower dental arch. Each aligner fully covers your teeth and is virtually invisible when in place. You wear each pair of aligners as instructed by your orthodontist. Procedure You will undergo a routine orthodontic pre-treatment examination (including x-rays, photographs and study models). Your orthodontist will take impressions of your teeth and send them, along with a prescription, to the Align laboratory. Align technicians will follow your orthodontist’s prescription to create a series of customized aligners. The Align laboratory will then mail the series of aligners back to your orthodontist. The total number of aligners varies depending on the complexity of your orthodontic case. The aligners are individually numbered and will be dispensed to you by your orthodontist with specific instructions for use. You will wear your aligners for approximately 20 to 22 hours per day, removing them only to eat and to brush and floss. Each aligner will be designed to guide your teeth to a more ideal position. Approximately every one to two weeks, you will switch to the next aligner in the series. Treatment duration typically lasts 6 to 30 months. Over the course of treatment your orthodontist will monitor your progress through a series of follow-up appointments. Benefits The Invisalign System offers you an attractive alternative to braces. The anticipated patient benefits of the Invisalign System are: Improved aesthetics. Aligners are nearly invisible when worn Reduced discomfort. Aligners do not cause the intraoral abrasive discomfort associated with conventional braces. Ease of use. Aligners require little or no maintenance or care, and are generally discarded after two weeks of wear. Improved oral hygiene. Aligners allow for normal brushing and flossing, tasks that are impaired by conventional braces. Risks and Inconveniences The use of the Invisalign System in your treatment may involve the kinds of complications or problems that can occur with conventional orthodontic treatment. Many of these problems and inconveniences can occur without orthodontic treatment, but the risk is greater to an individual wearing an orthodontic appliance. The risks associated with conventional or Invisalign System orthodontic treatment may include the following: Periodontal disease, tooth decay or permanent marking (e.g. decalcifications) on the teeth can occur if orthodontic patients eat foods with excessive sugar and/or do not brush their teeth frequently and properly. In some patients the length of the roots of the teeth may be shortened during orthodontic treatment. Some patients are more prone to this happening than others. Usually this does not have significant consequences, but on occasion it may become a threat to the longevity of the teeth. The health of the bone and gums which support the teeth may be affected by orthodontic tooth movement, particularly if a condition already exists and in some rare cases where a condition does not appear to exist. Teeth may shift their position after treatment. Faithful wearing of retainers at the end of orthodontic treatment should reduce this tendency. Throughout life, the bite can change adversely from various causes, including growth changes, playing of musical instruments and other oral habits. All of their causes may be out of the control of the orthodontist. Occasionally, problems may also occur in your temporomandibular joint (jaw joint), causing joint pain, headaches or ear problems. For many patients, orthodontic treatment temporarily affects their speech and they may experience a lisp, although any speech impediment caused by the aligners usually disappears within a few days. A tooth may have been previously traumatized or may have fillings that can cause tooth nerve damage. Orthodontic tooth movement may on occasion aggravate this condition and in rare instances may lead to the need for root canal treatment and caps (crowns). Orthodontic appliances may be accidentally swallowed or aspirated, or may irritate or damage oral tissues (however, there is no greater risk with the aligners than with other appliances, such as dentures or orthodontic retainers). The gums, cheeks and lips may be scratched or irritated by blows to the mouth. Post-adjustment tenderness (or in the case of the Invisalign System, tenderness experienced after switching to the next aligner in the series) should be expected and the period of tenderness or sensitivity varies with each patient and the procedure performed. Oral surgery (e.g. tooth extraction) may be necessary in conjunction with orthodontic treatment, especially to correct crowding or severe jaw imbalances. If such surgeries are necessary, risks associated with treatment and anesthesia should be discussed with the oral surgeon. Atypical formation of teeth may limit the ability to achieve the desired result. It may take longer than expected to complete treatment. Excessive or deficient bone growth, poor cooperation in wearing the appliance the required number of hours per day, not using the aligners as indicated, lost or broken appliances, and missed appointments can lengthen the treatment time and affect the quality of the end results or the ability to achieve the desired results. General medical conditions can affect orthodontic treatment. You should advise your orthodontist of any medical conditions you have. No Assurance/ Guarantees No assurance or guarantee can, has or will be made to you regarding the outcome of the treatment. Orthodontics is not an exact science, and therefore neither Align Technology nor any orthodontist can guarantee any specific outcome. Alternative Treatments For most patients, orthodontic treatment is an elective procedure. One possible alternative is no treatment at all. You could choose to live without orthodontic correction or improvement. The Specific alternative to the orthodontic treatment of any particular patient depends on the nature of the patient’s teeth and supporting structures. Alternatives to the Invisalign System might include conventional orthodontics with braces or possible prosthetic solutions (bonding, veneers, and crowns). Consent I have been given time to read and have read the above information describing the Invisalign System. I understand the benefits and the risks and inconveniences associated with the use of the Invisalign System as outlined above. I acknowledge that no assurances or guarantees have been made to me by Align Technology or any other person or company concerning any specific outcome of my treatment. I have been sufficiently informed about the Invisalign System and have had the opportunity to ask questions. Top
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