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1 Informed Consent Risks and limitations of Orthodontic Treatment The American Association of Orthodontists recommends that you are provided with the following information if you are considering orthodontic care. If you are a parent or guardian of the patient, you are agreeing that you have read, understood and agreed to this information on behalf of the patient. Please take time to read this information carefully, ask if you have any questions, and initial the boxes where requested to indicate you understand and agree. Benefits of Orthodontic Treatment Orthodontics is an exciting treatment that can help to provide better dental health, hygiene, and comfort, improved appearance, and an enhanced sense of self-esteem for the patient. As a general rule, an informed and cooperative patient can achieve very positive results. To help ensure that this happens, we give the following information to all patients considering orthodontic treatment so that, while recognizing the benefits of healthy teeth and a pleasing smile, they are nonetheless aware that orthodontic treatment has limitations and potential risks. These risks are seldom serious enough to indicate that treatment should be avoided, but they should be considered in making the decision whether or not to undergo orthodontic treatment. Orthodontic treatment usually proceeds as planned; however, as in all areas of the healing arts, results cannot be guaranteed, nor can all consequences be anticipated. The purpose of orthodontic treatment is to improve the patient’s bite and to distribute the forces of chewing throughout the mouth to minimize the stresses on the bones, roots, gum tissue and jaw joints. In this way, orthodontics can eliminate certain dental problems, such as abnormal tooth wear, and reduce tooth decay and gum disease by making normal brushing and flossing easier and more effective. Risks of Orthodontic Treatment All forms of medical and dental treatment, including orthodontics, have risks and limitations in addition to their benefits. While orthodontic complications are relatively infrequent considering the thousands of people that undergo orthodontic treatment every day, and even when they do occur are often minor, no medical treatment should be undertaken without a full appreciation of the risks, from slight discomfort to occasional more serious complications. While not all of the following risks may be relevant to your particular situation, you should understand them and accept the possibility of such complications in your case so that you can decide whether the benefits of treatment for you outweigh the possible risks. Please consider the following risks carefully and initial where requested to show that you understand and accept the risk and understand what you can do, if anything, to minimize the risk: 2 Hygiene Tooth decay, gum disease, or decalcification (permanent white markings) on the teeth may occur, particularly if you eat foods containing excessive sugar or do not brush properly and floss frequently enough. Excessive drinking of soda (regular or diet), sports drinks, end even fruit juice can cause or worsen decalcification. While this is a risk with or without braces, the risk is greater to a person wearing braces and can be aggravated if you regularly drink only well or bottled water rather than tap water, which is typically fluoridated. Children who do not drink fluoridated water can be prescribed fluoride drops, and toothpaste containing fluoride can help. To help you to avoid these problems, the bonding agents and cements we use often contain fluoride to protect your teeth underneath and around the braces, though they cannot, of course, protect near or below the gum line or between the teeth. When we bond your braces to your teeth, we will provide you with an oral hygiene kit and instructions on how to care for your teeth and braces. It is mandatory that you continue regular dental visits, maintain good oral hygiene, and rinse with a fluoridated mouth rinse so that your teeth and gums receive the best possible care. We may also require that you see your regular dentist more frequently, especially if you have periodontal problems. Remember, good, daily, oral hygiene is the responsibility of the patient and not the orthodontist. I understand this risk and what I need to do to minimize it. Periodontal Disease While orthodontic treatment overall tends to reduce the possibility of tooth loss or gum infection due to the misalignment of the teeth or jaws, the bone and gum tissue supporting the teeth may be affected by orthodontic tooth movement, especially when poor oral hygiene and unhealthy conditions already exist, and even in some rare cases when there is no prior indication. Inflammation of the gum tissue and loss of the supporting bone can occur during orthodontic treatment, particularly if the bacterial plaque is not removed daily through good oral hygiene. If you have pre-existing periodontal disease, or if such a condition occurs during orthodontic treatment, your periodontist or dentist should monitor this condition throughout your orthodontic treatment. Also, if the teeth were very crowded to begin with, the gum tissue may not fill the space below the contact point of the teeth resulting in the appearance of a triangular space. If the periodontal problem cannot be controlled, orthodontic treatment may have to be discontinued and braces removed prior to completion. I understand this risk and what I need to do to minimize it. Root Resorption In some patients, particularly adults and patients in treatment for a long time, the stress of the treatment may cause the roots of some teeth to become shorter during orthodontic treatment. This is usually minimal and relatively insignificant, but in more serious cases it may become a threat to the longevity, stability, or mobility of the teeth. Also, impacted teeth (teeth that have become blocked while pushing through the gum into your mouth) can sometimes resorb the roots of adjacent teeth as well as those teeth with very small, thin roots. Because we cannot predict which patients will have root resorption, we may require periodic x-rays to check that the roots of your teeth remain healthy. I understand this risk and what I need to do to minimize it. Relapse Orthodontics is about moving teeth in a carefully planned and monitored way. However, teeth may continue to change their positions after treatment. For this reason, you will be provided with retainers after your braces are removed, which you will likely wear for several years at least and which should help the teeth to remain in place. Throughout life, as the jaw grows, as new teeth (particularly wisdom teeth) come in, or as other changes occur, your bite may change. This can be caused by genetic influences controlling the size of the tongue, teeth and the jaws or by mouth breathing, tongue thrusting, playing musical instruments, and other “oral habits” that are beyond the control of the orthodontist. Sometimes tooth or jaw positions may change adversely following treatment to a degree that additional treatment or even surgery is recommended. I understand this risk and what I need to do to minimize it. 3 Tooth Development, Eruption The development and eruption of teeth is a complex processes. Sometimes primary (baby) teeth become fused to the bone (ankylosis) and will not move. This is particularly true when there is no permanent tooth to follow the primary tooth. The fused primary tooth then remains lower than the rest of the teeth that continue to erupt during normal development. Often these teeth need to be removed. This problem can also occur in permanent teeth, particularly if they have suffered trauma, have an unusual eruption path, or require surgical exposure. Sometimes, impacted teeth that require surgical exposure may be ankylosed and therefore need to be removed. There is no way to assess ankylosis prior to attempted movement of the tooth. Teeth requiring removal may need to be replaced with an implant. I understand this risk. Extractions Some orthodontic treatment will require the removal deciduous (baby) teeth or permanent teeth. There are additional risks associated with the removal of teeth which you should discuss with your family dentist or oral surgeon prior to the procedure. I understand this risk and what I need to do to minimize it. Orthognathic Surgery Orthognathic surgery (surgical realignment of jaws) is sometimes necessary in conjunction with orthodontic treatment, especially to correct crowding or severe jaw imbalances. There are additional risks associated with these procedures which you should discuss with your oral and maxillofacial surgeon prior to the procedure. If you require orthognathic surgery and elect to discontinue the orthodontic treatment without completing the recommended surgery, you may have a malocclusion that is worse than when you began treatment. I understand this risk and what I need to do to minimize it. TMD, TMJ Occasionally problems may occur in the jaw (temporomandibular) joints (TMJ), causing pain, headaches, ear problems, popping of the jaw, or difficulty in opening or closing the mouth. These symptoms are more common in a patient who clenches or grinds his or her teeth, chews on hard objects, has suffered trauma to the face or jaws, or has a poorly balanced bite. These problems may occur with or without orthodontic treatment. Any of these symptoms should be reported to the orthodontist immediately and may require treatment from a variety of specialists. I understand this risk and what I need to do to minimize it. Nerve Damage. A tooth that has been traumatized by an accident or deep decay may have experienced damage to the nerve of the tooth. Orthodontic tooth movement may, in some cases, aggravate this condition. In some cases, root canal treatment may be necessary. In severe cases, the tooth or teeth may be lost. Similarly, a tooth that has been previously traumatized by an accident or that has a large filling may have suffered damage to the nerve of the tooth that orthodontic movement may, in some cases, aggravate and which may require root canal therapy or even removal of the tooth. Often in such situations, root canal therapy or extraction may have eventually been required even if orthodontic treatment had not been done. I understand this risk. General Discomfort The mouth is a very sensitive area, so you can expect an adjustment period and some discomfort due to the orthodontic appliances. Tenderness is normal and usually does not last more than a few days. If you are suffering more than minor discomfort, you should call your orthodontist immediately for an evaluation of your condition. Non-prescription pain relievers such as ibuprofen may be used to relieve the discomfort, though their use is not recommended for extended periods. Standard precautions should be taken not to mix medications with alcohol consumption. I understand this risk and what I need to do to minimize it. 4 Injury from Orthodontic Appliances Your orthodontic appliances are composed of very small parts connected together. They could be accidentally swallowed, aspirated, or could irritate or damage your lips, cheeks, tongue and gums, especially if they break unexpectedly. You should avoid activities and foods that may damage your braces. Cheeks and lips may be scratched or irritated by loose or broken appliances or by trauma to the face or mouth. If you are prescribed headgear as a part of your treatment, and if headgear is handled inappropriately, pulled or caught unexpectedly, or treated roughly, the appliance may cause injury to the face or eyes, even blindness (there have been a few reports of injury to the eyes of patients from wearing headgear). You should never play sports, roughhouse or engage in horseplay while wearing headgear, and we urge caution at all times when wearing any orthodontic appliances. You are encouraged to wear a protective mouth guard when playing sports or in activities where there is a risk of injury. Ask your orthodontist what the best type of mouth guard is for you. I understand this risk and what I need to do to minimize it. Tooth Injury Damage to a tooth, restoration, veneer, or crown is possible when your braces are removed or in the event of impact or abuse while wearing braces. Abnormal wear of the teeth is also possible if a patient grinds the teeth excessively. If a patient treats his or her braces without proper care, the enamel of the teeth may be damaged since the braces are bonded to the teeth. You should report any damage to teeth or tissue to your dentist or orthodontist immediately and understand that restoration or other emergency treatment may be required. I understand this risk and what I need to do to minimize it. Third Molars As third molars (wisdom teeth) develop, your teeth may change alignment. The orthodontist will monitor them in order to determine when and if the third molars need to be removed. I understand this risk and what I need to do to minimize it. Materials Sensitivity Most braces are made of stainless steel that contains nickel, though the type of appliance, construction and material content may vary. Some patients may be allergic to nickel or may have allergies to other components or bonding materials that may result in adverse reactions and require alteration of cessation of orthodontic treatment with corresponding limits on the success of the treatment. Although exceedingly rare, medical management of dental material allergies may be required. Immediately inform your dentist or orthodontist if you experience swelling, redness, hives, prolonged discomfort, pain, or any symptom of an allergic reaction. I understand this risk and what I need to do to minimize it. Occlusal Adjustment. You can expect minimal imperfections in the way your teeth meet following the end of the treatment. An occlusal equilibration procedure may be necessary, which is a grinding method to use fine-tune the occlusion. It may also be necessary to remove a small amount of enamel in between the teeth, thereby “flattening” surfaces in order to reduce the possibility of a relapse. I understand this risk and what I need to do to minimize it. Non-Ideal Results Due to the wide variation in the size and shape of teeth, missing teeth, or abnormal position of the teeth such as transposition, an ideal result (for example, complete closure of space) may not be achieved. Restorative procedures may be required for a successful treatment. The most common types of dental treatment are cosmetic bonding, crown and bridge restoration and/or periodontal therapy. You should ask your dentist or orthodontist about the types of adjunctive care recommended for you. I understand this risk and what I need to do to minimize it. Treatment Time The total time required to complete treatment may be more than or less than the estimate you have been given. Excessive or deficient bone growth, poor cooperation in wearing the appliances including headgear and elastics for the prescribed time, poor oral hygiene, broken appliances, missed appointments and other factors can lengthen the treatment time and can adversely affect the quality of the end result. I understand this risk and what I need to do to minimize it. 5 Health General medical problems, such as bone, blood or endocrine disorders, can affect the orthodontic treatment. You should keep your orthodontist informed of any changes in your health status. I understand this risk and what I need to do to minimize it. Use of Tobacco Products Smoking or chewing tobacco has been shown to increase the risk of gum disease and interferes with healing after oral surgery. Tobacco users are also more prone to oral cancer, gum recession, and delayed tooth movement during orthodontic treatment. If you use tobacco, you must carefully consider the possibility of a compromised orthodontic result. I understand this risk and what I need to do to minimize it. Temporary Anchorage Device (TAD) Your treatment may include the use of a temporary anchorage device(s) (i.e. metal screw or plate attached to the bone.) There are specific risks associated with these devices. It is possible that a screw could become loose which would require its removal and possible relocation or replacement with a larger screw. The screw and related material may be accidentally swallowed. If the device cannot be stabilized for an adequate length of time, an alternate treatment plan may be necessary. It is possible that the tissue around the device could become inflamed or infected, or the soft tissue could grow over the device, which could also require its removal, surgical excision of the tissue and/or the use of antibiotics or antimicrobial rinses. It is possible that the screws could break (i.e. upon insertion or removal.) If this occurs, the broken piece may be left in your mouth or may be surgically removed. This may require referral to another dental specialist. When inserting the device(s), it is possible to damage the root of a tooth, a nerve, or to perforate the maxillary sinus. Usually these problems are not significant; however, additional dental or medical treatment may be necessary. Local anesthetic may be used when these devices are inserted or removed, which also has risks. Please advise the doctor placing the device if you have had any difficulties with dental anesthetics in the past. I understand this risk and what I need to do to minimize it. Possible Alternatives to Orthodontic Treatment Orthodontic treatment is an elective procedure for most patients. One possible alternative to orthodontic treatment is no treatment at all. You could choose to accept your present condition and decide to live without orthodontic correction or improvement. Alternatives to orthodontic treatment vary from patient to patient and may include, among others, extraction of permanent teeth, orthognathic surgery, or prosthetics (bridge work or false teeth). You may wish to discuss these treatment alternatives with your orthodontist before beginning orthodontic care. I understand the alternatives to orthodontic treatment. Limited or Incomplete Treatment If your treatment is terminated for any reason, whether or not it is your choice to do so, before the course of treatment is complete, or if you seek treatment to address only a specific area (e.g. aligning only the front teeth for aesthetic reasons), this may not result in a favorable alteration of the bite or alignment of the jaw and may not lead to the result that you expect. Therefore, selecting an option less than the ideal therapy may have less than ideal results. I understand this risk and what I need to do to minimize it. In any of the complications mentioned above does occur, a referral may be necessary to your family dentist or another dental or medical specialist for further treatment. Whether treatment for such complications is performed by us or by a specialist to whom you have been referred, fees for these services are NOT INCLUDED in the cost you have been quoted for orthodontic treatment. I understand and accept this risk. By signing this authorization where provided below, I hereby acknowledge that: I have read the materials provided to me in this “Informed Consent” detailing the Risks and limitations of Orthodontic Treatment and fully understand the treatment considerations and risks presented and discussed. I have had the opportunity to ask, and I have asked, any questions that I wish to ask, and I have received full and satisfactory answers and explanations. 6 I understand that there may be other problems not covered in the materials with which I have been presented because they may occur less frequently or are less severe. I understand and acknowledge that no specific result is guaranteed in my orthodontic treatment and that the actual results of orthodontic treatment vary from patient to patient, are dependent on many factors beyond the control of the orthodontist, and may be different from the anticipated results. Consent to Undergo Treatment I have been asked to make a choice about my treatment and hereby give my fully informed consent to orthodontic treatment. I hereby further consent to making and keeping of diagnostic records, including x-rays, during and following orthodontic treatment and acknowledge that those records may be used by the orthodontist and dental staff in connection with my treatment, for billing and collections purposes, for teaching or instructional purposes, and to support insurance claims. I fully understand the risks associated with the treatment. Without limitation, I understand the relationship of orthodontic treatment and the following: Hygiene, Root Resorption, Periodontal Disease, Retainers, TMJ/TMD, Tooth Development/Eruption, Traumatized Teeth, Orthodontic Discomfort, Tooth Injury, Headgear, Jaw Surgery, Growth, Occlusal Adjustment, Treatment Time, Ceramic Braces, Material Sensitivity, Tooth Variation, TAD, Nerve Damage, Use of Tobacco Products, Allergies and overall Health, Limited or Incomplete Treatment. Authorization for Release of Patient Information I hereby give my permission for the release of my records to other health care providers as deemed appropriate by the treating doctors in accordance with the HIPAA Privacy Act. I understand that once released, the releasing party has no responsibility for any further release by the recipient. I am either a patient over the age of 18 years (“Patient”) or, if the patient is under 18, I am the patient’s parent, guardian, or authorized representative with legal authority to sign on behalf of the patient (“Responsible Party”). If I am the Responsible Party, I understand that I am giving consent, for the patient and I am fully responsible for all fees, costs, and charges exactly as if I were the Patient. AUTHORIZATION Signature of Patient (if over 18) Date Signature of Orthodontist Date Witness Date Responsible Party (if not Patient) If you are consenting to the care of another: I have the legal authority to sign on behalf of the Patient. Name: _____________________________________________Relationship to Patient: ________________________ Signature Date Witness Date 7