Introduction

Align Technology (Align) revolutionized orthodontic treatment with the introduction of the Invisalign® clear aligner system in 1997. Clear aligners are medical devices and orthodontic treatment is a complex discipline that involves the movement of a patient’s teeth through bone. As a result, we believe it is essential that trained orthodontists and/or dentists are directly involved in every step of treatment – from determining whether the potential patient is a good candidate for treatment through the diagnosis and prescription of treatment, to treatment planning, clear aligners fitting, and the ongoing monitoring of the patient throughout treatment.

As a category leader and technological innovator, Align has invested more than $2 billion in technology aimed at improving orthodontic and dental treatment for patients worldwide. Since 2015, Align has consistently increased its annual R&D investment, with annual spending exceeding $345 million in recent years. The company has a significant portfolio of active patents, with nearly half in the U.S. and the remainder internationally, along with hundreds of pending patent applications worldwide, reflecting its ongoing commitment to innovation. With its robust research and development capabilities, Align was acknowledged as a global top innovator in both the 2022 and 2023 Lexis/Nexis Innovation Report ^{1 2} and was included among the top 300 organizations granted US patents in 2023; coming in at #270 in the US Intellectual Property Owners Association annual report with 158 U.S. patents granted, a 36% increase compared to 2022. ³ For more information about Align and its innovation efforts, please visit the Investors portion of our website.

Align continues to drive the technological evolution of dental practice to help dental health professionals transform the patient experience and improve outcomes, not just in orthodontics but in preventive and restorative dentistry as well.

Align is committed to providing facts and serving as a credible source of information about the benefits of comprehensive digital dentistry, including not only clear aligner treatment and intraoral scanning, but digitally supported methods that are improving diagnosis, prevention and restorative care. The views presented on this site reflect our belief that having an accredited dentist direct and monitor every aspect of dental care – especially clear aligner therapy -- is essential to ensure both patient safety and successful outcomes. Our goal is to provide information about the digital evolution occurring in dentistry and the future of dental treatment.

¹https://www.lexisnexisip.com/innovation-report-2023
²https://www.lexisnexisip.com/resources/innovation-momentum-2022-the-global-top-100/
³https://investor.aligntech.com/news-releases/news-release-details/align-technology-among-top-300-worldwide-organizations-granted

Introduction to clear aligners

Clear aligner therapy has revolutionized orthodontic treatment and been embraced by dental practitioners and their patients since 1997. As of December 2024, approximately 19.5 million patients have been treated with Invisalign clear aligners worldwide; of them approximately 5.6 million teen aged patients. It’s a treatment revolution begun and made possible, in large part, by Align’s steady investments in continuous innovation – proprietary software for virtual modeling and treatment planning, rapid state-of-the-art manufacturing processes and mass customization and materials that are simultaneously stiff enough to move teeth, yet flexible enough for a patient to comfortably and easily insert or remove an aligner from their mouth as needed.

All orthodontic treatment including clear aligner therapy, whether complex or straightforward, is a medical treatment that moves a patient’s teeth through the bone of their jaw. In the U.S., the European Union and most other countries around the world, clear aligners are designated as Class IIa⁴ medical devices just like conventional “brackets and wire” braces. However, instead of affixing brackets directly to a patient’s teeth and using wires and in-practice manual adjustments to achieve the desired clinical outcome, a computer-simulated digital treatment plan is created, and a series of doctor-prescribed, clear plastic, removable aligners are manufactured to the specific physical features of each individual patient’s teeth. Align then delivers the clear aligners to the treating dentist or orthodontist, where they are checked for fit by the practitioner and the first sets of clear aligners are provided to the patient. Patients then wear each set of aligners for a period of time as determined by their doctor – usually between 7 and 14 days -- after which patients switch to a new pair, with each set of aligners gradually and gently moving the teeth closer to the desired final position.

Many patients find that orthodontic treatment with removable clear aligners is more easily adapted into their everyday lives. For example, they can be removed to play a musical instrument or to participate in various sports in which a mouth guard is required. This flexibility extends to adult patients who may choose not to wear their clear aligners to an important social event. And because all patients treated with clear aligners can easily remove them for ordinary daily activities such as eating, drinking, brushing, and flossing, patients can maintain good dental hygiene throughout treatment.

Today many companies offer clear aligners, but not all clear aligners are Invisalign aligners and not all clear aligner treatment and clear aligner technology are the same. Backed by more than two decades of innovation, the Invisalign® System is the most advanced clear aligner system in the world. This is why the Invisalign brand name is at times inappropriately used as a generic term to describe the entire clear aligner category. This may create confusion among potential patients as to which clear aligner options are actually prescribed and monitored by doctors.

Like traditional “brackets and wire” braces, the Invisalign System can be used, sometimes in combination with other orthopedic appliances or surgery, to address all classes of orthodontic malocclusions.

But Align’s vision is more far reaching – digitally-designed fully integrated clear aligner treatments that simultaneously combine effective skeletal, functional or developmental corrections with teeth straightening. This vision is already a reality for growing children and adolescents.

Align introduced the Invisalign® Palatal Expander System⁵ -- a series of direct, 3D-printed orthodontic appliances for skeletal and dental palatal expansion in growing patients and adults (with surgery or other techniques), first available in Canada in 2023. Customized for each patient based on digital scans, the Invisalign Palatal Expander System offers patients and their parents a removable alternative to traditional metal palate expanders with a sequential course of devices that gradually enlarges a patient’s arch over time. This innovation aims to improve the comfort and effectiveness of treatment for young patients with malocclusions, addressing key challenges associated with palatal expansion, such as meticulous oral hygiene, reduced emergency appointments, frequent in-mouth manual screw adjustments, and parental concerns about discomfort during treatment ⁵. Since its introduction in Canada, the Invisalign Palatal Expander System has received further regulatory approvals and been launched in the U.S., Australia, New Zealand, Vietnam, Hong Kong, and Singapore. It has received CE Mark in Europe and has also completed registration with MHRA for the United Kingdom and overseas territories. Additional regulatory approvals expected in other countries in the future.

For children as young as 6 who need Phase I or "interceptive" orthodontic treatments (including arch expansion) to address problems or alignment issues that could become worse as they grow and provide a foundation for permanent teeth, there is Invisalign First™. Designed to accommodate the shorter clinical crowns and erupting teeth of children, Invisalign First can provide predictable dental arch expansion and concurrently adjust the bite relationship⁶ straighten teeth and address a broad range of challenges young patients face without the need for additional appliances.

For children and teens with Class II malocclusion, or “overjet”⁷ , who need bite correction, the Invisalign® System with mandibular advancement is the first clear aligner treatment introduced to allow doctors to simultaneously move the patient’s jaw forward and align their teeth – something traditional braces can’t do without additional functional appliances. ⁸ to allow doctors to simultaneously move the patient’s jaw forward and align their teeth – something traditional braces can’t do without additional functional appliances.

Today with its breadth of capability, the Invisalign System can be used to treat approximately 90%⁹ of cases in patients ranging from children as young as 6 to adults. Our goal is a future where every child is scanned and evaluated between 5 and 8 years old to establish a strong skeletal foundation for lifetime oral health and clear aligners are the first choice of doctors for every patient no matter how complex their orthodontic needs.

⁴ For further reference: Under Regulation (EU) 2017/745 on medical devices (as amended), Annex VIII, Rule 5, clear aligner systems are classified as Class IIa medical devices in the EU [ https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20200424]
⁵ The Invisalign Palatal Expander System is currently available in the U.S., Canada, Australia, New Zealand, Hong Kong, and Singapore, and is expected to be available in additional markets, pending regulatory approvals. The Invisalign Palatal Expander System is expected to be commercially available across EMEA in Q1 2025. https://investor.aligntech.com/news-releases/news-release-details/align-technology-has-received-ce-mark-europe-invisalignr-palatal
⁶ Bite relationship is the position of the upper and lower jaws and teeth
⁷ “overjet” is a dental condition in which the upper front teeth extend horizontally away from the mouth
⁸ Invisalign with mandibular advancement was introduced in 2017
⁹ Q1 Earnings, April 28, 2021

Clear aligner orthodontic treatment is a medical procedure

Clear aligner treatment, like any other orthodontic treatment, is a complex discipline that involves the movement of a patient’s teeth through bone. Clear aligners are medical devices that require a doctor’s prescription, and whether labeled “complex”, “simple” or “cosmetic”, all orthodontic treatments constitute a medical procedure that warrants direct involvement by a licensed orthodontist or dentist beginning with diagnostic assessment through treatment planning, treatment and eventually post-treatment retention.

Only accredited orthodontists or dentists have the training and experience to perform a physical clinical examination, including examination of other diagnostic studies such as scans and X-rays, needed to assess the underlying structures that support the teeth, and review the patient’s full dental health history to determine if they are suitable for clear aligner treatment. This professional oversight is also essential to develop and prescribe an appropriate treatment plan and monitor a patient’s progress (all the way through ‘retention’) to ensure the patient’s treatment is progressing as planned and to immediately identify any unintended consequences, or compliance issues.

When conducted in a responsible manner, clear aligner treatment provides patients with an effective, discreet, and convenient treatment option to straighten their teeth.

Clear aligner therapy has been embraced by dental practitioners and patients around the world, and information about it can be obtained from many sources -- not all of which accurately convey important facts that patients and potential patients should know to decide if this particular orthodontic treatment option is appropriate for them. To learn the Five Facts To Know About Clear Aligner Therapy, see our summary here.

Questions to consider before starting clear aligner treatment

Every person is different, and not every individual is a good candidate for clear aligner therapy. Each case must be assessed by a licensed dentist or orthodontist to identify any potential underlying oral health conditions that would preclude or delay the start of treatment until those issues are addressed. In addition, the treatment alternatives and potential risks must be communicated to the potential patient. To find the right treatment, potential patients should keep the following questions in mind when consulting a dentist or orthodontist:

• What treatment options are available to correct my misaligned teeth?

For decades the standard of care for orthodontic treatment was conventional "brackets and wire" braces, which affix brackets directly to a patient’s teeth and use wires and manual adjustments to achieve the desired clinical outcome. But over the past two decades, clear aligner therapy has increasingly become an accepted and desirable treatment alternative. With clear aligner treatment, dentists and orthodontists create a digital treatment plan and provide the patient with a series of made-to-measure removable clear plastic appliances that gradually, and more gently, move the teeth into the desired position.

• Should I have a personal consultation with a trained, independent dentist or orthodontist before starting treatment?

To determine which treatment option is best suited for a patient, a comprehensive in-person clinical examination should be performed by an accredited dentist or orthodontist to determine whether a patient’s oral health makes them a good candidate for treatment. Based on a thorough oral health history and physical exam (including a review of recent X-rays or bone imaging that allow the doctor to visualize the structures under the gumline), an independent dentist or orthodontist can consult with the patient and prescribe the treatment method best suited to the patient, their malocclusion, and their lifestyle.

• What should my dentist or orthodontist and I know about my oral health and oral health history before I undergo clear aligner therapy?

Patients should undergo an in-practice dental exam by a licensed dentist or orthodontist before treatment begins to confirm they do not have any cavities, active periodontal disease, or other contra-indications that preclude beginning orthodontic treatment. In the examination, it is essential for an orthodontist / dentist to review a patient's most recent diagnostic digital or conventional radiographs or other equivalent bone imaging analysis suitable for orthodontia to obtain a clear visualization of the patient’s teeth in the bone of the jaw. Digital scans alone cannot provide data on the periodontium or tooth structures below the gumline. It is also crucial to know whether a patient has any allergies, whether they have any implants or have undergone previous restorations. A treating dental health professional should therefore gain a comprehensive understanding of a patient’s oral health condition and history before recommending any treatment options.

• Who will provide me with medical guidance throughout my treatment and perform the clear aligner fitting?

Before beginning clear aligner treatment, it is crucial for patients to know who will be monitoring their treatment and addressing questions or issues that may arise. To ensure that all advice provided, and decisions made are based on medical expertise and the patient’s individual dental history, patients should ask for and receive contact information for the dentist or orthodontist who prescribed and is following their treatment. This dentist or orthodontist should be a patient’s primary point of contact to answer questions and address concerns throughout treatment. This includes ensuring that the initial set of aligners fit well and need no adjustments. When prescribing the clear aligners and creating the treatment plan, the treating dentist or orthodontist may decide that attachments (extra features which help practitioners execute complicated tooth movements) are needed to achieve the desired outcome. If that is the case the attachments will typically be applied during the first aligner fitting.

• If the outcome of my treatment is not what I was promised or expected, who will be responsible for addressing my concerns?

Patients deciding to have clear aligner therapy should have a thorough understanding of who is legally responsible for his or her treatment and what process will be followed if questions or problems arise. If patients are unsure about who will be legally responsible for their treatment, they should ask. Before treatment begins, patients should always understand who will address their complaints if they are dissatisfied with the outcome of their treatment. Align believes that the treating dentist or orthodontist is best positioned to resolve complaints relating to treatment. In addition, the treating doctor should be independent and not bound to one treatment method or company to ensure patients have a complete understanding of the available treatment options.

• Are continued, periodic in-practice visits important for my treatment? Will I continue to have those visits with this dentist or orthodontist to monitor my treatment?

A number of key factors should be considered when thinking about the need for regular in-practice visits with the treating dentist or orthodontist throughout treatment. Although using digital communications and applications to monitor treatment is fast and potentially more convenient, these digital check-ins should supplement rather than replace all in-practice exams. Periodic physical check-ups by a dentist or orthodontist are crucial and essential to determine whether a patient’s treatment is proceeding as planned. Teledentistry can enhance patient education and the doctor-patient relationship between practice visits and address any questions or concerns that do not require an immediate appointment at the practice. Although in-practice visits are crucial for an efficient and safe clinical outcome, Invisalign treatment requires on average 30% fewer doctor visits than fixed orthodontic appliances¹⁰.

• How long should I expect my clear aligner treatment to take?

The length of each patient’s particular treatment time is a complex question that can and should only be answered by an accredited dentist or orthodontist after an in-practice physical exam. The practitioner’s estimate of the duration of treatment fundamentally depends on many factors, including a patient’s dentition, the desired and achievable outcome, the individual’s dental health history and their willingness to comply with the recommended aligner daily ”wear-times” needed to timely and fully achieve the desired outcome. Simple cases involving only minor tooth movements may be achieved in a few months while more complicated tooth movements, that can only be treated with advanced clear aligner systems and require attachments, may take 12 months or longer¹¹.

• Will I need to sign a contract? If so, what should I expect?

Yes, a contract is generally required to initiate clear aligner therapy. Before a patient signs a contract with their treating dentist or orthodontist, they should take the time to read the terms and conditions carefully and make sure they understand them to make an informed consent. They should also understand who is responsible for their treatment, any complications and where to address potential questions or complaints. Patients should never be deprived of the right to connect with a doctor to discuss potential issues.

The importance of retention.

Orthodontic retention is defined as maintaining teeth in the desired aesthetic and functional position after treatment. Retention is essential to preserve orthodontic treatment results, and use of a suitable retention method is important to prevent relapse and maintain patient satisfaction with their treatment. Align believes that retention [link] is fully as important as any other stage of treatment and is what helps patients maintain and safeguard the investment they’ve made in their smile.

¹⁰ Buschang et al; Comparative time efficiency of aligner therapy and conventional edgewise braces. Angle Orthod 1 May 2014; 84 (3): 391–396; Borda et al; Outcome assessment of orthodontic clear aligner vs fixed appliance treatment in a teenage population with mild malocclusions. Angle Orthod 1 July 2020; 90 (4): 485–490
¹¹ *Gu, J et al. Evaluation of Invisalign treatment effectiveness and efficiency compared with conventional fixed appliances using the Peer Assessment Rating index. Am J Orthod Dentofacial Orthop February 2017;151:259-66
*Buschang, P et al. Comparative time efficiency of aligner therapy and conventional edgewise braces. Angle Orthodontist, Vol 84, No 3, 2014

What is doctor-led treatment and why is it important?

Orthodontic treatment is a complex discipline that involves the movement of a patient’s teeth through bone. It is essential that accredited orthodontists or dentists are directly involved in patient assessment, prescription, treatment planning and ongoing monitoring of the patient through treatment, including retention. This oversight is particularly relevant to clear aligner treatment because, with removable appliances, the monitoring of patient compliance with the required daily “wear-time” of their aligners is an essential element to timely and fully achieving the desired outcome. Doctor-led care in clear aligner treatment therefore means that a licensed dentist or orthodontist is responsible for all steps of the treatment to not only ensure the best patient outcome but also to protect the patient’s safety and to serve as a point of contact for any questions or concerns a patient might have.

Furthermore, it should be understood that all orthodontic treatments, including clear aligner treatment, are medical procedures, even when they are referred to as “simple” or “cosmetic” treatments. Clear aligner treatment is no exception and must be planned and regularly monitored by a licensed dentist or orthodontist to ensure the teeth are moving according to plan.

The need for direct doctor involvement starts before treatment begins. An in-practice physical exam before treatment can identify individuals who are not good candidates for treatment or have underlying oral health conditions like periodontal disease (gum recession) that would preclude or delay the start of treatment until those issues are addressed. A thorough in-practice physical clinical exam, including review of radiographs (X-rays) or other bone imaging to “see below the gum line” is key to identifying these individuals. For those who are good candidates, an exam at the practice accompanied by a 3D digital scan of their teeth or professionally taken physical impressions provides the information necessary to create well-designed orthodontic treatment plans. Proper fitting aligners that can improve tooth movement lead to better treatment outcomes and potentially reduce treatment time. The accredited dentist responsible for a patient’s treatment and outcomes should review and approve the treatment plan.

On the contrary, should clear aligner therapy begin without the necessary in-person examination and evaluation of a patient’s mouth, gums, teeth, roots, and underlying structures — including a review or taking of X-rays – by a licensed orthodontist or dentist, could lead to undesirable treatment outcomes. When done improperly or on a patient who is not a good candidate for treatment, clear aligner treatment can create bite or soft tissues problems, or even cause loss of tooth vitality (compromised blood flow to teeth that can lead to loss of sensitivity, color change or necrosis of the pulp tissue and tooth loss).

When questions or complications arise during the course of therapy, patients need to be able to consult with their treating dentist or orthodontist to get resolution or reassurance that their case is continuing to progress according to plan, or have it amended to address their specific situation. Many questions can and should only be answered by an accredited doctor that knows the patient and their medical history, and if action is needed, be able to make the right decisions. Maintaining a strong, direct doctor-patient relationship from start to finish is critical and a right for any patient.

Ensuring patient safety in the age of digital dentistry

Like other dental and orthodontic treatments, clear aligners are medical devices and clear aligner therapy is a medical treatment that requires a doctor’s examination, evaluation and monitoring whether undertaken for functional or aesthetic purposes. Laws, regulations, and practice standards must evolve to ensure that technological advancements that offer improved patient outcomes do not result in the disintermediation (i.e., removal) of dentists and orthodontists whose expertise is key and continue to prioritize and protect patient’s best interests and safety. This includes the use of teledentistry in clear aligner therapy.

Responsible tele-dentistry can deepen doctor-patient relationships and enhance communication.

Digital communication technologies and applications (teledentistry) can serve as an effective, convenient way for doctors and potential new patients to become acquainted before the first office visit. Once a patient begins treatment, teledentistry can further build and enhance established doctor-patient relationships by adding a convenient way for doctors to communicate with patients between office visits.

The responsible use of teledentistry occurs when an authorized, licensed dental health professional uses an electronically supported patient interface (such as telehealth systems, electronic technologies, media, or combinations of these tools) to consult with, monitor or provide advice related to dental treatment to prospective or current patients when the individual is in a different physical location from the dental health professional.

Teledentistry includes two-way audio, audio/video communications and/or written or text communications via telephone, smart phone, tablet computer or PC in which a patient's health information (including questions, requests, photographs, videos) is shared with a dental health professional and an exchange between the doctor and patient takes place. These methods should be used to supplement in person visits and enhance doctor-patient communication.

When used responsibly by independent dental professionals, teledentistry can enhance patient care, improve patient outcomes, and strengthen the relationship between doctor and patient. It should not be used to alter dental practice in ways that minimize or eliminate doctor-directed care and/or increase risk to patients. We believe laws, regulations and practice standards should evolve to incorporate these new tools while continuing to ensure that accredited orthodontists / dentists responsibly direct and manage patient care.

Professional positions on responsible clear aligner treatment

Clear aligner treatment offers doctors an effective way to treat patient malocclusions using digital technology and provides patients a discreet, comfortable, convenient alternative to traditional braces. Several medical societies and associations, who are considered respected authorities in the field of dentistry and orthodontia, have published opinions and expert positions outlining their views on what constitutes responsible clear aligner therapy.

They all stress that clear aligner treatment is always a medical procedure that results in better patient outcomes when a doctor is directly involved from start to finish of a patient’s treatment journey. As no binding standard for responsible clear aligner treatment currently exists, these expert opinions offer crucial guidance to consumers who may be considering therapy and also provide a framework for policy makers whose goals are to reap the benefits brought by technological advancement while assuring that patients continue to receive the benefits of doctor-directed care – great clinical outcomes and safe treatment.

As category inventor, Align is committed to driving and raising awareness of responsible, doctor-directed clear aligner treatment. We appreciate that stakeholders wish for comprehensive information to better understand what is involved in clear aligner therapy and how important oversight and guidance from a trained accredited dentist or orthodontist are to assuring good outcomes. Accordingly, we offer not only our own perspective but also the views expressed by experts to provide another dimension to discussions of this important topic.

Below you will find links to the valuable third-party expert opinions on clear aligner treatment and teledentistry:

• [EUROPE] The European Federation of Orthodontic Specialists Associations (EFOSA) has prioritized patient education on the risks of non doctor-directed clear aligner treatment and published several dedicated materials to raise awareness:
  • a joint declaration, underscoring that any treatment of malocclusions should be exclusively performed by a fully qualified dentist. In addition to a clinical examination of the patient, EFOSA rejects exclusive remote treatment of patients as potentially hazardous to the patient’s health. [> LINK] [LINK TRANSLATION]
  • a patient education section [> LINK] containing market specific videos as well as materials of the American Association of Orthodontists
  • a comprehensive two-part article (part one [> LINK]; part two [> LINK]) outlining risks and concerns as well as steps that EFOSA is taking.

• [EUROPE] The Council of European Dentists (CDE) published a position paper on direct to consumer orthodontics in late 2023 [> LINK] that outlines concerns and recommendations, also highlighting the role AI may have in this area.

• [FRANCE] The French Association of Orthodontic Specialists (SFSO) has launched a campaign [> LINK] in 2022 to highlight the potential dangers of direct to consumer clear aligner treatments. This resulted in broad media coverage in which SFSO members explain the potential risks.

• [FRANCE] The Ordre Chirurgiens-Dentistes published in the September-October issue of their magazine a piece [> LINK] that states they have alerted the Ministry of Health concerning direct to consumer clear aligner treatments and are calling for a necessary regulatory change.

• [GERMANY] In 2021, the BZÄK (Federal Dental Chamber) issued a position paper which underscores that clear aligner treatment constitutes the practice of dentistry. [> LINK] [LINK TRANSLATION]

• [GERMANY] The Dental Chamber North Rhine published an overview of their actions against DTC clear aligner companies, stating it has “been dealing with aligner stores on an almost daily basis for five years, has over 100 cases and proceedings as well as patient complaints on file and has initiated countless political discussions and correspondence.” [> LINK]

• [GERMANY] In 2021 the Free Democratic Party’s (FDP) introduced a motion to promote patient safety in aligner treatment [> LINK] [LINK TRANSLATION] Several associations as well as individual specialists were asked to submit statements for the public hearing held on the motion. The statements can be accessed via the German Bundestag’s website: [> LINK] [LINK TRANSLATION]

• [GERMANY] The German consumer organization ‘Verbraucherzentrale’ (VZBV) published a report on commercial aligner providers in August 2021. [> LINK] [LINK TRANSLATION]

• [PORTUGAL] The Portuguese dental association Ordem dos Médicos Dentistas (OMD) has launched a public education campaign out of concern about the growing availability of clear aligner remote treatments without the direct and physical involvement of a dental professional. [>LINK] [LINK TRANSLATION]

• [SPAIN] The Spanish Association of Orthodontists (AESOR) has published a report listing 50 risks associated with remote orthodontic treatments. [>LINK] [LINK TRANSLATION]

• [SPAIN] The Sociedad Española de Ortodoncia (SEDO) published a protocol outlining ten points the organization considers necessary in clear aligner treatment. [> LINK] [LINK TRANSLATION]

• [SPAIN] The Consejo General de Dentistas de España issued a press release strongly emphasizing the need for medical supervision in aligner treatments. [> LINK] [LINK TRANSLATION]

• [United Kingdom] The British Orthodontic Society (BOS) published guidance on teledentistry, explicitly addressing digital monitoring of clear aligner treatments and emphasizing that patient care must continue to be provided by orthodontists or adequately trained dentists. [LINK]

• [UNITED KINGDOM] The British General Dental Council (GDC) published guidance on its website that explicitly addresses patients to educate them on what to keep in mind to ensure safe clear aligner treatment. [> LINK] [LINK TRANSLATION]

• [UNITED KINGDOM] The English Care Quality Commission (CQC) issued a statement, underscoring all companies providing clear aligner treatment need to register with them, so patient safety can be monitored and ensured. [> LINK] [LINK TRANSLATION]

• [EUROPE] The European Federation of Orthodontic Specialists Associations (EFOSA) published a joint declaration, underscoring that any treatment of malocclusions should be exclusively by a fully qualified dentist. In addition to a clinical examination of the patient, EFOSA rejects exclusive remote treatment of patients as potentially hazardous to the patient’s health. [> LINK] [LINK TRANSLATION] 

• [North America] The American Dental Association (ADA) reaffirmed in December 2023 its policy [>LINK] opposing direct-to-consumer dentistry, highlighting the potential for irreversible harm to individuals, who are treated as “customers” rather than as patients. This includes potential bone loss, lost teeth, receding gums as well as bite problems and jaw pain.

The Safe Smiles Campaign in the UK

The Oral Health Foundation, together with the British Orthodontic Society, the British Society of Dental Hygiene and Therapy, the British Dental Industry Association, and other partners, have launched a campaign in the UK that stresses the importance of dental treatment being provided by trained and registered professionals in dental practices. Safe Smiles is a dental industry response to concerns about increased consumer acceptance of treatment options where the degree of direct doctor involvement, and the risks of undergoing treatment without that close doctor oversight, are poorly understood. Research conducted prior to the campaign found that people are motivated to change their smiles, and that the pandemic has driven changes in consumer behavior.

Commenting on the research findings, Dr. Nigel Carter OBE, CEO of the Oral Health Foundation said, “We are extremely concerned by evidence suggesting the UK’s oral health habits have declined during the pandemic, and that many people are taking to DIY treatments at home to either fix or cover up any problems. We have seen first-hand the severe and long-term damage that can be caused. Never take risks when it comes to your smile. For the best, safest, and most effective treatment, always see a dental professional in a dental practice.” The Safe Smiles campaign urges every UK citizen or resident to visit local dental practices and have treatment carried out by clinicians registered with the UK’s General Dental Council.

Dental Technology

News/ Positions

“Patient’s Bill of Rights”

Position on Responsible Practice of Clear Aligner Therapy

Position on NCDs

Position on teledentistry

Position on Use of Artificial Intelligence (AI) in Dentistry

Position on Prenatal Dental Care

More about Align Technology

To learn more about Align, our technologies and our work to drive continued evolution in dental practice please see the following information:

Align Overview Document
Align comments to WHO consultation
Align comments to MHRA consultation

Invisalign, Align, iTero, and exocad, among others, are trademarks and/or service marks of Align Technology, Inc. or one of its subsidiaries or affiliated companies and may be registered in the United States and/or other countries.