OrthoFX has announced the launch of its new generation of advanced clear aligner polymer, NiTime clear aligners. NiTime is designed for improved predictability and compliance offering a patented HyperElastic polymer with AirShell technology, which requires 9-12 hours of wear time to straighten teeth according to the company.
NiTime is reportedly the first and only clear aligner system explicitly designed for shorter wear time and cleared by the US Food and Drug Administration (FDA) 510(k) and is now available nationwide in the US for doctors to treat all classes of dental malocclusions. OrthoFX is showcasing the new material at the American Association of Orthodontists (AAO) annual meeting in New Orleans, US, from 3-6 May 2024.
According to OrthoFX, the NiTime clear aligner differs from conventional aligners in the market with a shorter wear time. It is designed for 9-12 hours of wear time without extended treatment duration versus the standard 22 hours required by leading aligner brands*. The NiTime is also designed for better predictability and compliance, with 92% of NiTime aligner treatments completed without refinements*.
Moreover, OrthoFX announced that NiTime outperforms the industry standard of 22 hours wear for almost all orthodontic movements, demonstrating up to 30% greater movement efficiency compared to other leading clear aligners*.
The NiTime is also said to nearly eliminates refinements with standard leading aligners exhibiting a 14% predictability of tooth movement compared to the treatment plan, whereas, NiTime’s AirShell technology demonstrated an astonishing 86% predictability, nearly eliminating the need for refinements throughout the entire treatment plan*.
“NiTime Clear Aligners are truly the most advanced innovation the category has seen in polymer science in decades. It is a testament to our commitment to solving real treatment challenges faced by providers and their patients. OrthoFX is the only aligner manufacturer for this proprietary polymer material compared to leading aligner manufacturers who are using off the shelf materials like Zendura A and Zendura FLX,” said OrthoFX co-founder, Ren Menon.
He added: “Our patented technology behind NiTime Aligners make patient compliance effortless by reducing wear time in half, and nearly eliminating the need for extended treatment time given most cases do not need refinements.”
According to the company, the HyperElastic polymer, featuring AirShell technology is designed to provide sustained optimal forces delivery, supporting natural bone tissue remodelling at its natural pace to straighten teeth and to compensate against daytime relapse. The patented HyperElastic polymer also aims maintains biologically favoured force levels, allowing predictable tooth movement with 9-12 hours of wear time.
Furthermore, the design of the new aligners aim to support favourable cellular physiology, fostering an ideal environment for biological tissue remodelling. This process involves the orchestrated activity of osteoclasts and osteoblasts, the key cells responsible for bone remodelling, ensuring optimal treatment outcomes.
“OrthoFX has disrupted the orthodontic industry by developing a real solution for lack of patient compliance with their NiTime Clear Aligners. Their distinctive and patented method, from polymer formulation to aligner design to manufacturing processes, effectively mitigates drastic drops in appliance pressure,” said Dr Neil Warshawsky, Assoc Prof of Orthodontics at the Craniofacial Center at the University of Illinois Health Center on the benefits of the aligner.
He added: “NiTime Clear Aligners are as gentle as NiTi wires commonly used in orthodontics due to its exceptional springiness and working range, meaning high elasticity at a relative constant force. The force levels applied by NiTime’s HyperElastic polymer are significantly lower than conventional aligners. As a result, my patients feel almost no discomfort while in treatment. I am seeing outcomes consistent with my treatment plans without the need for multiple refinements.”
OrthoFX was founded by a team of clear aligner industry pioneers who are said to have played a critical role in innovating and scaling the first and second-generation aligner materials and systems. The NiTime aligner system became available to a limited group of orthodontic practices in 2023, and is now available for doctors to provide patient treatment. *Data on file at OrthoFX
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