Summary: The American Dental Association (ADA) has released the first US standard related to orthodontic sequential aligners for public comment, aiming to establish consistent criteria for comparing aligner materials across different manufacturers.
Key Takeaways:
- First U.S. Standard: This is the first U.S. standard specifically addressing materials used for orthodontic sequential aligners.
- Comparison and Testing: The standard allows for comparisons of aligners based on their physical, thermal, and mechanical properties.
- Public Comment Period: The draft standard is open for public comment until October 10.
The first United States standard related to orthodontic sequential aligners is available for review and comment from the American Dental Association.
“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,” said Hera Kim-Berman, DDS, project lead for proposed ANSI/ADA Standard No. 188 for Dentistry — Materials Used to Produce Orthodontic Sequential Aligners. “This makes it difficult for practitioners, patients and regulators to compare them.”
Standard Requirements for Aligners
The standard will allow sequential aligners to be compared in a like manner with respect to their physical, thermal, and mechanical behaviors. For example, the standard requires specific mechanical testing that will allow comparisons to be made between the strength and flexibility of products made by different manufacturers.
Comprehensive Testing and Labeling
The standard specifies requirements and test methods for materials used in the production of orthodontic sequential aligners, along with requirements for packaging and labeling. The document includes materials that are thermoformed into sequential aligners, as well as materials that are used to additively manufacture sequential aligners.
“Developing specific standard test methods and criteria to address important dental materials is crucial for researchers, industry professionals and clinicians to better understand and identify their optimal characteristics for enhanced patient care,” said Spiro Megremis, PhD, chair of the ADA Standards Program Working Group 1.7 on Orthodontic Products.
Public Comment Deadline
A copy of the draft standard is available online. The deadline for comments on the new standard is Oct 10.
Proposed ANSI/ADA Standard No. 188 for Dentistry – Materials Used to Produce Orthodontic Sequential Aligners. Regarding this attempt to standardize the above I suggest to start with reviewing the patent by Craig A Andreiko US20130078593A1 “Orthodontic appliance and method of orthodontic treatment”. Having personally made thousands of alignrs for laboratory customers there are many attributes to consider. Obviously the efficacy of tooth movements but also clarity and ease of manufacturing. All of which have to pass required toxcity profile.