The Science of Aligners: What Are They Made Of and Are They Safe?

Curious about what clear aligners are actually made of? This guide explains the medical-grade thermoplastics used in modern aligner trays, BPA-free safety standards, and what UK patients should know before starting treatment.
Who This Article Is For
This guide is for UK adults who are considering invisible braces and want to understand exactly what they would be putting in their mouths for months at a time. It is a reasonable question — and one that deserves a thorough, transparent answer.
You may find this article particularly useful if you:
- Have concerns about plastics, BPA, or chemical safety in dental products
- Have allergies or sensitivities and want to know what materials are involved
- Are comparing different aligner brands and want to understand material differences
- Simply want to make an informed decision before committing to treatment
Note: This article covers the science and safety of aligner materials. If you have specific medical concerns or known allergies, we would always recommend discussing these with your clinician before starting any treatment.
Key Definitions in Plain English
Thermoplastic — A type of plastic that becomes mouldable when heated and hardens when cooled. This property allows aligner trays to be precisely formed over a 3D model of your teeth.
Polyurethane — A family of polymers widely used in medical devices. Most modern aligner materials are polyurethane-based, chosen for their clarity, flexibility, and biocompatibility.
BPA (bisphenol A) — A chemical historically used in some plastics that has raised health concerns. Reputable clear aligner materials are BPA-free.
Biocompatible — A material that is designed to function in contact with living tissue without causing harm. Medical-grade aligner plastics undergo biocompatibility testing before clinical use.
Medical device — In the UK and EU, clear aligners are classified as custom-made medical devices, subject to regulatory requirements covering safety, materials, and manufacturing.
Attachments — Small tooth-coloured bumps made from dental composite (similar to filling material) bonded to teeth during treatment. They help aligners grip and guide more complex tooth movements.
IPR (interproximal reduction) — A technique where tiny amounts of enamel are carefully removed between teeth to create space for movement. No foreign material is introduced.
Refinements — Additional sets of aligner trays produced during treatment to fine-tune tooth positions. Learn more about how refinements work.
What Are Clear Aligners Made Of?
If you have ever wondered what clear aligners are made of, the short answer is: medical-grade thermoplastic polymers. But there is more nuance worth understanding.
The Core Material: Thermoplastic Polyurethane
Most premium aligner systems use a form of thermoplastic polyurethane (TPU) or a closely related co-polyester. These materials are specifically engineered for dental applications and are chosen because they offer:
- Optical clarity: The material is virtually transparent, making aligners far less noticeable than traditional metal braces
- Controlled flexibility: Stiff enough to apply gentle, sustained force to teeth, yet flexible enough to be inserted and removed comfortably
- Durability: Designed to resist cracking, staining, and deformation during the one-to-two-week wear period of each tray
- Biocompatibility: Tested for prolonged contact with oral tissues, saliva, and the fluctuating temperature and pH environment inside the mouth
How the Material Becomes an Aligner
The journey from raw material to finished aligner typically follows these steps:
- A 3D scan of your teeth is taken, creating a precise digital model
- Specialised software maps out the planned tooth movements, stage by stage
- A 3D printer creates a physical model of each treatment stage
- A flat sheet of thermoplastic is heated and vacuum-formed (or pressure-formed) over each model, creating the custom tray shape
- The tray is laser-trimmed to follow the gum line accurately and polished smooth
The result is a set of trays, each slightly different from the last, that guide your teeth through a planned sequence of movements.
Material Variations Between Brands
Not all aligners use identical materials. Different manufacturers have developed proprietary formulations — some are single-layer, others are multi-layer laminates that combine a rigid outer shell with a softer inner layer for comfort. The specific material can affect:
- How much force the tray delivers (and how it changes over the wear period)
- Stain resistance and clarity retention
- Comfort during insertion and removal
- How well the tray maintains its shape over time
Your clinician selects an aligner system based on clinical suitability for your case — material quality is one of many factors in that decision.
Are Clear Aligners BPA-Free and Safe?
This is one of the most common questions patients ask, and it is an important one. Here is what the evidence shows:
✅ BPA-Free
Reputable aligner manufacturers use BPA-free materials. BPA (bisphenol A) is not used in the formulation of modern medical-grade aligner plastics. Independent laboratory testing routinely confirms this.
✅ Biocompatibility Tested
Aligner materials undergo cytotoxicity, sensitisation, and irritation testing (following standards such as ISO 10993) to confirm they are safe for prolonged contact with oral tissues.
✅ Regulatory Oversight
In the UK, clear aligners are regulated as custom-made medical devices. Manufacturers must comply with the Medical Devices Regulations 2002 (and forthcoming UKCA requirements), ensuring traceability, safety documentation, and quality controls.
✅ Phthalate and Latex-Free
Quality aligner materials are also free from phthalates (plasticisers linked to health concerns) and latex, making them suitable for patients with common allergies.
A Balanced Perspective on Plastic Safety
While the safety profile of modern aligner materials is strong, it is fair to acknowledge the broader context:
- Micro-level leaching: Some laboratory studies have detected trace amounts of chemicals released from thermoplastics in simulated oral environments. However, the levels measured are typically far below thresholds considered harmful by regulatory bodies.
- Heat sensitivity: Exposing aligners to hot liquids (such as drinking hot tea while wearing them) can theoretically accelerate material degradation. This is one reason clinicians advise removing aligners before consuming hot drinks.
- Long-term data: Clear aligners have been in clinical use since the late 1990s, with no widespread adverse events linked to material toxicity. However, like all medical materials, ongoing research continues to refine our understanding.
The bottom line: plastic braces safety is well-supported by current evidence, regulatory standards, and decades of clinical use. If you have specific concerns about chemical sensitivities, discuss these with your clinician — they can provide information about the exact material used in your treatment.
What Clear Aligners Can Do (and What They Cannot)
What They Can Do
- Correct mild to moderate crowding, spacing, and certain bite issues
- Deliver controlled, gentle forces through a series of custom trays — each moving teeth incrementally (typically 0.2 mm per stage)
- Offer a discreet, removable alternative to fixed braces — often referred to as invisible braces
- Allow normal brushing and flossing, supporting better oral hygiene with aligners compared to fixed brackets
- Be combined with attachments and IPR to handle more complex movements
What They Cannot Do
- Treat severe skeletal discrepancies that require jaw surgery
- Reliably move teeth without patient compliance — 22 hours of daily wear is essential
- Guarantee perfect results; refinements are often needed to fine-tune the outcome
- Replace the need for retainers after treatment — teeth will shift without retention
- Address underlying dental health issues such as decay or gum disease (these must be treated first)
Cleaning and Wear Safety
How you care for your aligners affects both the material's integrity and your oral health. Here are the key points:
Heat
Thermoplastics soften when exposed to high temperatures. Never clean aligners with boiling or very hot water, and avoid leaving them in direct sunlight or a hot car. Warm (not hot) water is fine for rinsing.
Cleaning Products
Use a soft-bristled toothbrush with clear, unscented liquid soap or purpose-made aligner cleaning crystals. Avoid toothpaste (which can be abrasive and create micro-scratches), mouthwash containing strong dyes, and denture cleaners not specifically recommended for aligners.
Micro-Scratches
Abrasive cleaning can create tiny surface scratches that harbour bacteria and reduce clarity. Gentle brushing in lukewarm water is the safest approach.
Staining
Remove aligners before eating or drinking anything other than plain water. Coffee, tea, red wine, and curry are common culprits for staining. Smoking and vaping can also discolour trays and affect oral health.
Storage
Always store aligners in their protective case when not in your mouth. This prevents damage, loss, and bacterial contamination. Wrapping them in tissue is a common cause of accidental disposal.
Step-by-Step: How Treatment Typically Works
Understanding the full process helps put the material science into practical context:
Step 1 — Initial Assessment
Your clinician examines your teeth, gums, and bite. Digital X-rays and a 3D scan create a precise picture of your current alignment. This is also where case suitability is assessed — not every patient is a candidate for aligners.
Step 2 — Treatment Planning
Using 3D software, your clinician maps out the planned tooth movements and reviews the simulation with you. You can see a preview of the expected outcome before committing. The number of aligner stages is determined at this point.
Step 3 — Manufacturing
Your custom aligners are manufactured — each tray thermoformed from medical-grade, BPA-free thermoplastic over a 3D-printed model of each treatment stage. Trays are laser-trimmed and quality-checked before shipping.
Step 4 — Fitting and Attachments
Attachments (small tooth-coloured bumps) may be bonded to specific teeth to help with tracking — ensuring each tray fits precisely and teeth move as planned. Your clinician checks the fit of your first trays and provides wear instructions.
Step 5 — Active Treatment
You wear each set of trays for the prescribed period (typically one to two weeks), aiming for at least 22 hours of daily wear. You progress through the series, with check-ups every six to eight weeks to monitor progress.
Step 6 — Refinements
If teeth have not moved exactly as planned, additional trays (refinements) are produced. This is a normal part of treatment and helps achieve the best possible result.
Step 7 — Retention
Retainers — either removable trays worn nightly or a thin bonded wire — are provided to hold teeth in their new positions. Retention is essential; without it, teeth naturally tend to drift back over time.
Suitability Checklist
This is a general guide — only a clinical assessment can confirm whether clear aligners are right for you.
✅ Signs That Treatment May Be Suitable
- Healthy teeth and gums (or willingness to address any issues first)
- Mild to moderate crowding, spacing, or bite concerns
- Good oral hygiene habits and commitment to maintaining them
- Willingness to wear aligners for at least 22 hours per day
- All permanent teeth have erupted (typically from mid-teens onward)
- No known allergy to medical-grade polyurethane or related plastics
⚠️ Signs That Extra Assessment May Be Needed
- Active gum disease, untreated decay, or significant bone loss
- Severe crowding, complex bite issues, or skeletal discrepancies
- Known sensitivities to plastics or adhesive materials
- Bruxism (teeth grinding) that may damage trays or affect treatment
- Medical conditions or medications that affect bone remodelling
- Difficulty committing to the required daily wear time
Risks, Side Effects, and Limitations
All medical treatments carry some degree of risk. Being informed helps you make a balanced decision:
- Temporary discomfort: Mild pressure and tenderness are common when starting a new set of trays. This usually settles within a few days and is a sign that the aligners are working.
- Speech changes: Some patients notice a slight lisp when they first start wearing aligners. This typically resolves within a week as the tongue adjusts.
- Dry mouth or increased saliva: The mouth may react to a new object by producing more (or less) saliva initially. This usually normalises quickly.
- Root resorption: A small degree of root shortening can occur with any orthodontic treatment. Clinicians monitor for this with periodic X-rays.
- Gum irritation: Tray edges can occasionally irritate the gums, especially if trimming is not precise. Your clinician can smooth any rough edges.
- Allergic reaction: Extremely rare with modern materials, but possible. If you experience unusual swelling, rash, or irritation, remove the aligner and contact your clinician.
- Treatment may take longer than expected: Compliance, biology, and case complexity all influence treatment time. Refinements may extend the process.
- Relapse without retention: Teeth will shift if retainers are not worn as prescribed after active treatment.
How Long Treatment May Take
Treatment time varies considerably depending on the complexity of your case and how consistently you wear your aligners. Here is a general guide:
| Case Complexity | Typical Duration |
|---|---|
| Mild crowding or spacing | 3–6 months |
| Moderate alignment + bite correction | 6–12 months |
| Complex full-arch treatment | 12–18+ months |
| Refinement stages | May add 2–4 months |
Key factors that influence timelines include: severity of misalignment, compliance with wear time (22 hours per day), biology (how quickly your bone remodels), and whether refinements are needed. Your clinician will provide an estimated timeline during your assessment — but it is important to understand this is always an estimate, not a guarantee.
Costs in the UK
Clear aligner treatment in the UK typically ranges from around £1,500 for straightforward cases to £5,500 or more for complex full-arch treatment. What drives the cost:
- Number of aligners: More stages of movement generally mean a higher fee
- Material and system: Premium aligner systems with advanced materials and software may cost more than budget alternatives — but the material quality, clinical support, and predictability can differ significantly
- Refinements: Some plans include refinements; others charge separately
- Retention: Retainers are usually an additional cost and are essential for maintaining results
- Clinic location: Fees tend to be higher in London and other major cities
For a more detailed breakdown, visit our clear aligner cost guide. Many clinics offer interest-free payment plans to help spread the cost.
Note: We cannot provide a specific quote without assessing your case. The figures above are indicative ranges and vary by provider and complexity.
Keeping Your Results: Retention and Aftercare
Active treatment is only half the journey. Retention is what keeps your teeth in their new positions long-term:
- Removable retainers: Custom-made clear trays (similar in material to your aligners) worn nightly. Most clinicians recommend indefinite nightly wear, or at minimum for the first 12 months.
- Fixed retainers: A thin bonded wire on the back of the front teeth, providing passive retention without daily effort. Not suitable for everyone.
- Retainer care: Clean retainers the same way you cleaned your aligners — soft brush, lukewarm water, no abrasive toothpaste. Replace them when they become worn or ill-fitting.
- Ongoing check-ups: Regular dental visits help catch any early signs of relapse, decay, or gum issues.
- Oral hygiene: Maintaining excellent brushing and flossing habits protects your investment in a straighter smile.
When to Seek Advice
If you are considering clear aligners and have any of the following concerns, it is worth speaking to a clinician:
- Known allergies to plastics, adhesives, or dental materials
- A history of severe gum disease or significant bone loss
- Concerns about a specific health condition and how it might interact with orthodontic treatment
- Previous orthodontic treatment that did not go as planned
- Uncertainty about whether your case is suitable for aligners versus other options
A good clinician will welcome these questions and take the time to address them. If a provider dismisses your concerns, consider seeking a second opinion.
Frequently Asked Questions
Are clear aligners made of BPA-free plastic?
Yes. Reputable aligner manufacturers use BPA-free medical-grade thermoplastics. BPA is not used in the formulation of modern aligner materials, and independent testing routinely confirms the absence of BPA in finished trays.
Can I be allergic to clear aligners?
Allergic reactions to aligner materials are extremely rare, but not impossible. If you have a known allergy to polyurethane, methacrylate, or other plastics, inform your clinician before treatment. They can check the specific material data sheet and, if needed, arrange a patch test.
Do aligners release chemicals into my mouth?
Some laboratory studies have detected trace amounts of substances released from thermoplastics in simulated environments. However, the levels measured are consistently well below safety thresholds set by regulatory bodies. In over 25 years of clinical use, no widespread adverse effects from aligner material chemistry have been reported.
Is it safe to wear aligners for 22 hours a day?
Yes, when used as directed. Aligner materials are specifically designed and tested for prolonged oral contact. The 22-hour daily wear time is the clinical recommendation for effective tooth movement. The remaining two hours allow for eating, drinking, and oral hygiene.
What happens if I drink hot liquids with my aligners in?
Hot drinks can warp the thermoplastic, distorting the tray's shape and reducing its effectiveness. This could also theoretically accelerate low-level chemical release. Always remove your aligners before drinking anything other than cool or lukewarm water.
Are cheaper direct-to-consumer aligners made from the same materials?
Not necessarily. While some direct-to-consumer brands use comparable materials, the quality can vary. More importantly, the clinical oversight, treatment planning, and ongoing monitoring may differ significantly. The material is only one part of a safe and effective treatment — the clinical process matters just as much.
How do I know if my aligners are from a reputable manufacturer?
Ask your clinician which aligner system they use and request information about the material. Reputable systems will have ISO-certified manufacturing, published biocompatibility data, and clear regulatory documentation. Your clinician should be able to provide this information transparently.
Can aligners cause gum problems?
Aligners themselves do not cause gum disease. However, poor oral hygiene during treatment — such as not cleaning teeth before reinserting trays — can increase the risk of plaque build-up and gum inflammation. Removable aligners actually make oral hygiene easier than fixed braces, provided you maintain a consistent routine.
Are the attachments safe too?
Yes. Attachments are made from dental composite resin — the same material widely used for tooth-coloured fillings. It is biocompatible, well-studied, and has been used in dentistry for decades. Attachments are removed at the end of treatment without damaging the tooth enamel.
Do I need to worry about microplastics from aligners?
The topic of microplastics is an area of active research across many consumer products. Currently, there is no clinical evidence suggesting that wearing aligners contributes meaningful microplastic exposure compared to everyday sources. However, following care instructions — avoiding abrasive cleaning and hot temperatures — helps maintain the material's integrity throughout each tray's lifespan.
📚 References and Further Reading
- Alexandropoulos A, Al Kentucky S, Al-Jundi M. — Cytotoxicity and genotoxicity of orthodontic thermoplastic aligners, European Journal of Orthodontics (2015)
- Eliades T, et al. — Characterisation and cytotoxicity of ions released from orthodontic appliances, American Journal of Orthodontics and Dentofacial Orthopedics (2004)
- Pratt M, et al. — Evaluating bisphenol A release from dental materials, Dental Materials (2003)
- MHRA — Medical Devices Regulation in the UK
- British Orthodontic Society — Patient Information and Resources
- ISO 10993 — Biological Evaluation of Medical Devices (International Organization for Standardization)
Curious About Clear Aligners? Let Us Answer Your Questions
Book an assessment and we will examine your teeth, explain the materials and process, and give you honest advice about whether clear aligners are the right option for you. No obligation — just clear, personalised answers.
Book Your AssessmentDisclaimer: This article is for general information only and does not constitute dental or medical advice. The safety and suitability of clear aligner materials may vary by manufacturer, and individual responses can differ. Treatment suitability, timelines, and costs can only be determined through an in-person assessment by a GDC-registered dental professional. If you have concerns about allergies or material sensitivities, please discuss these with your clinician before starting treatment.
Written by Pro Aligners Team
Medically reviewed by Pro Aligners Team • GDC: 195843