ADA releases first standard for clear aligner materials

Dental Tribune International

Fri. 20 September 2024

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CHICAGO, US: Aligner therapy has revolutionised the treatment of malocclusion; however, regulators have been unable to keep pace with the rapid market expansion. US dental associations played a pivotal role in reigning in direct-to-consumer providers to improve patient safety, and efforts are well under way to regulate the materials used in the aligner manufacturing process. Last month, the American Dental Association (ADA) released a draft version of the first national standard on aligner materials. The public has until 10 October to provide feedback on the standard, which aims to provide a framework for characterisation of the mechanical, physical and thermal properties of aligner materials.

The proposed standard mandates specific mechanical testing to enable comparison of the strength and flexibility of aligners made by different manufacturers. It outlines the necessary requirements and test methods for both thermoforming and additive manufacturing materials used in the production of aligners and stipulates requirements for the packaging and labelling of aligners.

Dr Hera Kim-Berman, leader of the project behind the draft standard, commented in an ADA press release: “Clear aligner therapy is widely used in orthodontic treatment. However, there is no dental standard that specifically addresses the characteristics of the materials used to produce orthodontic sequential aligners, neither for thermoformed nor additively manufactured aligner materials.” She added: “This makes it difficult for practitioners, patients and regulators to compare them.”

The ADA is accredited by the American National Standards Institute to develop standards for dental applications and has been doing so since 1928. According to the ADA, “these standards establish requirements for safe and effective dental products and technologies through a consensus-based process”. The ADA Standards Program working groups consist of volunteers who contribute their expertise to the development of standards and represent clinicians, health bodies, academic institutions and the dental industry.

“Developing precise test methods and criteria for key dental materials is essential for researchers, industry professionals and clinicians to better understand and identify their optimal characteristics, ultimately improving patient care,” commented Dr Spiro Megremis, chair of the ADA Standards Program Working Group 1.7 on Orthodontic Products, which helped develop the standard.

The proposed standard—American National Standards Institute/ADA Standard No. 188—can be accessed here. Visit ADA.org/dentalstandards to learn about more about the standards programme.

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