Informed consent

"Informed Consent."

While Orthoclear aligner treatment can lead to a healthier and brighter smile, you should be aware that every orthodontic treatment has limitations and risks that you should weigh before deciding to undergo the treatment. Learn more about the benefits and risks of Orthoclear treatment below. Have a question? Email us at uk@ortho-clear.com or use our Whatsapp.

What is expected of you

Before we start treatment we ask you to make an appointment with your own dentist, after which your dentist:

  • If necessary, took x-rays of your teeth; 

  • Checked for cavities, loose or defective fillings, crowns or bridges and repaired as needed;

  • Checked x-rays and determined that there were no shortened or resorbed roots; 

  • Checked x-rays and determined that there were no affected teeth;

  • Examined or measured the gums for pockets and determined that you have no periodontal or gum disease;

  • Performed a complete oral cancer screening within the past 6 months and determined that you do not have oral cancer; 

  • Whether dental hygienist cleaned your teeth.

Periodic checkups with your own dentist remain necessary and your own responsibility. With this comes the obligation to inform Orthoclear, and the independent dentist/orthodontist engaged by it who oversees your treatment, of any results of these periodic checkups in a timely manner.

Risks - Orthoclear Clear Aligners

Orthoclear Clear Aligners are not suitable for everyone and may pose certain risks. For example:

  • Allergic reaction
    The plastic used to make your aligners may cause an allergic reaction. Should this happen, stop using them immediately and let Orthoclear and your doctor know.

  • Black triangles
    Teeth that have overlapped for a long time may be missing some gum tissue. If they no longer overlap due to treatment, a "black triangle" (a bit of space between the tooth and gums) may appear at the site of the overlap.

  • Cavities, gum disease or periodontal disease
    While using your clear aligners, you may get cavities, tooth decay, gum disease or permanent markings (e.g., decalcification) sooner or more often. This also happens if you eat or drink a lot of sweet things, or don't brush and floss your teeth before placing the aligners, or don't see a dentist every six months. Sometimes you can also get discoloration or white spots; small cavities can get bigger, causing sensitivity and in some cases pain or tooth breakage; gingivitis can increase and cause pain and or bleeding. If you do not have these types of problems checked or treated regularly, they may become more frequent, leading to tooth loss. You may then have to stop using your aligners.

  • Damage to nerves in teeth
    Tooth movement can accelerate damage or death of a nerve, requiring root canal or other dental treatment, or causing you to lose a tooth. There is no way to predict the likelihood of nerve damage, but if you have had previous dental injuries or restorative work on a tooth, you are at higher risk. If your own dentist sees nerve damage before or during your clear aligner treatment, stop your treatment immediately to prevent possible tooth loss.

  • Discomfort
    When using your clear aligners, you can expect some sensitivity in your mouth, especially during the adjustment period. Your gums, cheek or lips may also become somewhat irritated. Although our clear aligners are aimed at straightening front teeth, your bite may also change and feel some temporary discomfort. Your bite may need adjustment after using the aligners (occlusal adjustment). This requires the advice of a dentist.

  • General health problems
    General medical conditions such as bone, blood or hormonal disorders as well as the use of medications (including bisphosphonates) can affect (the outcome of) your treatment.

  • Impacted, unusually shaped, missing and supernumerary teeth
    Impacted, unusually shaped, missing or supernumerary teeth can affect aligner adjustment and the attainability of desired results If you have impacted, unerupted or supernumerary teeth, clear aligners may not be a good idea. Short clinical crowns can cause difficulty in holding the appliance in place and hinder tooth movement.

  • Oral Piercings
    Piercings can damage your clear aligners or even cause broken teeth. Therefore, you should remove piercings in or near your mouth throughout the treatment process.

  • Previous dental treatment.
    Clear aligners will not move implants and may have no effect with some dental restorations, such as bridges. In addition, the use of clear aligners may result in the need to replace dental restorations, such as crowns, veneers, (large) fillings or bridges, due to tooth movement.

  • Safety
    Clear aligners can break, be swallowed or inhaled. Always follow the Orthoclear Clear Aligner instruction guide and never use your clear aligners other than what they are intended for.

  • Shortening or root
    The roots of your teeth can become shorter (resorption) with possible tooth loss while using clear aligners. The likelihood of this cannot be predicted, but if you have ever had braces, or still have baby tooth(s) then you are at higher risk. Resorption can lead to tooth loss. If your own dentist signals resorption, you should stop using your clear aligners immediately.

  • Supra-eruption
    If a clear aligner does not cover a tooth properly, the tooth may move outward, which can lead to problems with cleaning, gum disease, tooth decay and tooth loss.

  • Temporary side effects
    During treatment, you may experience temporary changes in your speech or saliva flow.

  • Temporomandibular joint dysfunction (TMJ).
    The use of clear aligners can create problems in the jaw joints that cause pain, headaches or ear problems. The following factors may contribute: past trauma or injury, arthritis, hereditary history, teeth grinding or clenching and some medical conditions.

molars
Shifting your molars is usually not part of the treatment, therefore your clear aligners will not always cover all molars and therefore have virtually no effect on the position of your molars.

Wisdom teeth
Do you have wisdom teeth? Then you can use clear aligners as usual. Orthoclear does recommend that you first consult with your own dentist or oral surgeon to determine your possible need and timing of removal of your wisdom tooth(s).

Never use clear aligners if any of the following apply to you: 

  • You have a severe open bite, severe overjet or severe overbite,

  • There is malocclusion requiring surgical correction

  • You have both milk and adult teeth

  • You have dentures or dental implants (in the front teeth region)

  • You have active periodontal disease (gum disease), active tooth decay or dental caries

  • You have permanent retainers

  • You have mental illnesses

  • You have a PETG material allergy

Other risks and warnings

Orthoclear is not intended to replace regular dental exams and dental care.

Orthodontic treatment and tooth movement involve potential risks and side effects. In the case of clear aligner therapy, such risks include (but are not limited to) discomfort, swelling, sensitivity, numbness, painful jaw muscles or allergic reaction to dental materials. There may also be unforeseen circumstances that become apparent during treatment, which may require extension of original procedures or information to other clients. 

Duration and results
Orthoclear emphasizes that the treatment you undergo through it under the supervision of an independent dentist it engages is an obligation of effort. It is explicitly not a result commitment. Orthoclear does not guarantee results. In fact, the duration of wearing the clear aligners and the results depend on many factors including, but not limited to: the general condition of your teeth, the shape of your teeth or how long you wear the aligners per day. The average person wears the clear aligners for 4 to 8 months for at least 20-22 hours a day. But the specific rate of tooth movement is impossible to predict and may take longer.

Do not discard your aligners until your treatment is complete and you have received your Orthoclear Night-Time Retainers. If at any time during treatment you are asked to go back to a previous aligner, such as if you lose an aligner, you must have all previous aligners available. If not, any additional costs will be your responsibility. 

Risks - Orthoclear Night-Time retainers

After the treatment is over, your teeth may move back a bit. Orthoclear Night-Time retainers can keep your teeth in their new position for a lifetime when worn every night. On average, a retainer does not last more than a year, but this can vary greatly from client to client. Because of wear and deformation, Orthoclear recommends buying new retainers at least once a year. 

Risks - Orthoclear Home Impression kit

In rare cases, the materials used in the Orthoclear Home Impression kit may cause an allergic reaction. For a complete list of ingredients, contact Orthoclear. As with any dental impression, there is a small risk of damage or loss of tooth structure, crowns, bridges, implants, bonded brackets or other dental work. Do not use Orthoclear Home Impression kit with dentures.

Do not swallow any material from Orthoclear's Home Impression kit. If this does happen, seek medical attention. As with anything placed in the mouth, choking is a risk.

Periodontal disease
Orthoclear Clear Aligners should not be used if you have active periodontal disease (advanced gum disease).

The symptoms
With periodontitis, the gums may be red, flabby, swollen and bleed when brushing or eating. Over time, the gums may begin to recede. A foul taste or bad breath may also indicate periodontitis. Teeth may also become more sensitive to temperature changes and biting force. Sometimes teeth loosen or a space develops between teeth that was not there before. Often these symptoms can also be absent! As a result, periodontitis can go undetected for a long time. So again, have your teeth checked regularly by your dentist and/or dental hygienist.

How to know if you have periodontitis
Your dentist and/or dental hygienist can determine with certainty whether you have periodontitis. They check the depth of the pockets (spaces between your teeth and gums) with a so-called pocket probe. They will also note, among other things, whether the gums bleed while measuring the pockets and the mobility of your teeth. X-rays can then determine whether and how much jawbone has broken off around the roots of the teeth as a result of the inflammation.

Risks - Orthoclear Whitening kit

  • Type of discoloration.
    Orthoclear's whitening kit will not lighten fillings or restorations in teeth. Blue, gray, multicolored or striped discoloration may not respond to whitening. If you have receding gums or advanced gum disease, the area of the tooth near the gum line may not respond to whitening. Similarly, fillings, cavities or other damage will not lighten. The use of cigarettes, wine, coffee, tea and similar stain-producing substances will also slow down the whitening process.

  • White/tooth colored fillings
    White or tooth-colored fillings do not lighten or may soften after using the whitening system. These fillings may need to be replaced after whitening.

  • Pregnancy
    Women who are or may become pregnant may start or continue whitening treatment during pregnancy only if she has received permission from her treating physician before starting or continuing treatment. While you do not need to provide a copy of this consent to Orthoclear, you agree that it is your duty to communicate with your physician before initiating or continuing whitening treatment during pregnancy. Orthoclear assumes no liability for complications that occur if the foregoing is not followed.

  • Sensitivity and irritation.
    Gum irritation may result from overuse of the bleaching system, such as throat irritation from swallowing the bleach. Tooth sensitivity may occur during initial use. In addition, discomfort and possible permanent nerve damage can occur if the bleach leaks into damaged or cracked dental fillings.

  • Reversible
    Bleached teeth can darken again over time. Reducing certain types of discoloring foods and beverages will reduce staining of teeth.

Alternatives

Alternatives to Orthoclear's clear aligner treatment include traditional braces, surgical options and living with your teeth as they are.

Informed Consent

By signing this Informed Consent, I confirm that:

  • My dentist/ dental hygienist cleaned my teeth;

  • My dentist took x-rays of my teeth; 

  • My dentist checked and repaired cavities, loose or defective fillings, crowns or bridges;

  • My dentist checked my x-rays and I have no shortened or resorbed roots; 

  • My dentist checked my x-rays and I have no affected teeth;

  • My dentist has examined or measured my gum pockets and says I have no periodontal or gum disease;

  • My dentist performed a complete oral cancer screening within the past 6 months and I do not have oral cancer; 

  • I have no pain in my teeth;

  • I have no pain in my jaws;

  • I don't have loose teeth;

  • I have no baby teeth and all my permanent teeth are present;

I also agree that, in the event that an independent dentist hired by Orthoclear to supervise my clear aligner treatment determines that additional observation by my personal dentist is required in order to proceed, that I will schedule an appointment and have any complications corrected within 30 days of such dentist notifying me of this.

I certify that I can read and understand the Dutch language. I understand the risks, benefits and alternatives described above when deciding to enter into an agreement to participate in clear aligner treatment from Orthoclear. I understand that in addition to discussing the information in this form with a clear aligner treatment dentist and giving my written consent by signing this form, I may be asked for verbal consent or other forms of consent.

This includes at least the online questionnaire provided by Orthoclear with a statement about the state of my teeth. I agree that any complications that may arise because I have not stated truthfully will be my responsibility. It is also my duty to have had a recent checkup of my teeth prior to treatment. Therefore, I also cannot claim that I was unaware of any complication or condition. Periodic checkups with my own dentist are and remain my own responsibility. With this comes the duty to notify Orthoclear, and the independent dentist engaged by it to oversee my treatment, of any results thereof in a timely manner. If I fail to do so, all risks of continuing the treatment are also my own responsibility. 

I hereby voluntarily consent to the Orthoclear Aligner treatment, having been informed of my obligations and of the risks and disadvantages of the treatment. I understand that the clear aligner treatment also evaluates the effect of treatment on health and dental care. This care evaluation includes diagnosis, consultation, the treatment itself, electronic and/or oral transmission of dental information or photographs and, if necessary, also medical information provided to a participating licensed dental professional. I understand that in order for this process to continue, Orthoclear will share my personal and medical information with third parties, in the context of diagnosis, clear aligner and treatment plans as well as for product manufacturing. I hereby consent to the sharing of this information with such parties. 

I hereby grant permission to Orthoclear to notify my dentist of my Orthoclear Clear Aligner treatment.

Neither Orthoclear nor any affiliated company has made any guarantees to me. The agreement with Orthoclear and the treatment agreement with the independent dentist it engages, is at all times an obligation of effort and never guarantees results. 

After reading this form, I fully understand the benefits and risks stated in this form regarding my treatment with Orthoclear Clear Aligners and whitening system. I understand that no specific results or overall results are guaranteed. Before signing this, I discussed Orthoclear Clear Aligner treatment with a dentist and was given the opportunity to ask questions about the use of aligners and Orthoclear's Clear Aligner treatment. By signing this form, I agree that my questions have been answered to my satisfaction. I further understand that the Orthoclear Clear Aligner treatment will not correct an existing bite condition. I understand that I should seek dental advice from a separate dental professional if I wish to correct a bite condition because although my teeth will be straighter, any pre-existing bite condition remains a risk.

Arbitration clause
All disputes that may arise as a result of the present agreement or further agreements resulting from it, will be settled in accordance with the Arbitration Rules of the Netherlands Arbitration Institute (NAI). The arbitral tribunal shall consist of one arbitrator who shall be appointed in accordance with the list procedure. The place of arbitration will be Amsterdam and the proceedings will be conducted in the Dutch language. Merging the arbitral proceedings with another arbitral proceeding, as provided for in Article 1046 of the Code of Civil Procedure and Article 39 of the NAI Arbitration Rules, is excluded.

Video/Photo Release
I hereby grant Orthoclear the irrevocable right and permission to use and disclose photographs and/or video recordings of me for the purpose of creating photographs or video clips, as well as stand-alone photographs/images in which I may appear and/or be heard, for use in internal Orthoclear publications and for the training of Orthoclear employees. Orthoclear's use of photographs or video recordings is limited to internal websites and publications. Orthoclear agrees that photographs or video clips will not be used on social media or public media platforms unless written permission is provided. In principle, the purpose of these recordings is for training purposes and internal use only. Photosand/or video recordings may also be posted on Review Sites, but only in response to a posted review.

I understand and agree that such photographs and/or video recordings of me may be posted on internal Orthoclear websites. I also understand and agree that I may be identified by name and/or title in such internal in print, as websites or broadcast information that might accompany the photographs and/or video recordings of me. I waive the right to approve the final product. I agree that all such portraits, photographs, video and audio recordings and all reproductions thereof, and all records, negatives, recording tape and digital files are and shall remain the property of Orthoclear.

I hereby release Orthoclear, its current and former directors, agents, officers and employees of the above entity, its affiliates or assigns, from all claims, demands, rights, promises, damages and liabilities arising out of or related to the use or distribution of said photographs and/or video recordings, including but not limited to claims for invasion of privacy, appropriation of likeness or defamation.

I hereby warrant that I am eighteen (18) years of age or older and competent to contract in my own name. This indemnification is binding upon me and my heirs, assigns and personal representatives.