Introduction
Aligners are customised plastic trays that are used to correct any dental misalignments. They can easily fit over your teeth, and move them to the desired position over time.
To show the desired results, aligners must be worn nearly all the time except while eating or brushing.1 It is therefore crucial to ensure the materials used in aligners are safe and compatible with the oral environment. Non-biocompatible materials can cause problems, like allergies or harmful effects, when they react with teeth, gums, or other dental materials.
In this blog, we will discuss how dental aligners are made safe for the body, their effect on comfort and health, and the safety tests they go through. This knowledge ensures you get healthy, strong smiles without any side effects with your aligner material.2
Why Aligners Need to be Biocompatible: Impact on Patient Health and Comfort
Biocompatibility in dental aligners is important because they remain in contact with the mouth for long hours every day. Aligners are exposed to saliva, heat, bacteria, and even habits like teeth grinding or jaw clenching. If the materials are unsafe, they could cause irritation, allergic reactions, or discomfort.1 The materials used should not release harmful substances that could adversely affect health. For example, some materials like latex used in some aligners might cause allergic reactions leading to burning sensations, tingling, or swelling in the mouth, and in some cases, even difficulty breathing.1,2 Others like Bisphenol-A (BPA), can break down inside the mouth and release harmful substances. BPA, found in some plastic aligners, can lead to health problems like hormonal effects or damage to cells.1 These if occur can be an issue for both patients and doctors. This is why choosing safe and biocompatible materials is crucial for patient health and comfort.3
Orthodontists must consider the patient’s oral health, treatment goals, and preferences to ensure the chosen aligner material enhances both comfort and overall health during treatment.2
Biocompatibility of Dental Aligner Materials
Clear aligners are made from different materials that have specific features that can affect how well they work and how safe they are for the body. Understanding how these materials work in the mouth helps orthodontists choose the right materials for treatment and avoid complications.
The commonly used materials in aligners are:
- PeT-G: This material is smooth and gentle on your gums. It does not cause much irritation, so it is very comfortable to wear.
- PP (Polypropylene): While a little stiffer, PP aligners might feel a bit uncomfortable at first, but this usually goes away as your mouth adjusts.
- PC (Polycarbonate): Known for being strong and durable, PC aligners can sometimes cause some gum irritation, especially when you first start using them.
- TPUs (Thermoplastic Polyurethanes): These are more flexible and elastic, making them more comfortable and less painful during the beginning of treatment.
- EVA (Ethylene-Vinyl Acetate): Soft and comfortable, EVA aligners are great for sensitive mouths and are less likely to irritate.4
Newer materials made using polymer blending techniques are also coming into use. These materials are more durable and biocompatible, ensuring the efficacy and safety of the aligner treatment.5 These advancements allow aligners to deliver desired results while maintaining patient comfort and overall well-being.
Ensuring Aligners Meet Safety Standards: Testing and Regulations
Aligners must go through strict safety tests to make sure they are safe for use in orthodontic treatments.6 These tests follow specific standards set by international organizations. Two key guidelines for testing aligners are ISO 10993-01 and ISO 7405. These standards explain these tests to verify that aligners are safe when in contact with the body. The tests evaluate if aligners cause harm, focusing on areas such as:
- Cytotoxicity: Ensuring they do not damage cells.
- Acute Toxicity: Checking for harmful effects in short-term use.
- Irritation and Sensitisation: Ensuring they do not irritate the mouth or cause allergies.
- Genotoxicity: Verifying they do not affect genetic material.7
This thorough testing process helps make sure the aligners are safe for patients.6
When choosing aligners, look for those made by manufacturers with strong safety and quality practices. Ensure the aligners are customized to your needs and monitored closely by your dentist during treatment. It’s also important to pick aligners that are BPA-free and latex-free to avoid any harmful reactions and ensure safe, effective use.7
By following these safety guidelines dentists, patients, and regulators can trust that aligners are reliable and suitable for orthodontic care.
Conclusion
Biocompatibility ensures dental aligners are safe, comfortable, and effective for long-term use. By using advanced materials and undergoing strict safety testing, aligners provide a reliable way to correct malocclusions. Considering the aligner cost, their discreet design and safety make them a valuable orthodontic option. Aligners not only enhance oral health but also boost confidence, offering a modern, patient-friendly approach to achieving a healthy smile without compromising on safety or comfort.