NiTime Clear Aligners Designed to Solve Patient Compliance Obstacle

On Monday, OrthoFX^TM announced the nationwide availability of NiTime^TM Clear Aligners, a new generation of advanced clear aligner polymer designed to straighten teeth with less wear time.

NiTime, the first and only clear aligner system explicitly designed for shorter wear time and cleared by the U.S Food and Drug Administration (FDA) 510(k), is now available for clinicians to treat all classes of dental malocclusions. OrthoFX will be showcasing the new material at the Anaheim Convention Center this week as the CDA Presents The Art and Science of Dentistry takes place Thursday through Saturday.

“NiTime Clear Aligners are truly the most advanced innovation the category has seen in polymer science in decades. It's a testament to our commitment to solving real treatment challenges faced by providers and their patients,” OrthoFX Co-founder Ren Menon says in a press release. “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. 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."

The NiTime Clear Aligner benefits and features include:

• Shorter Wear Time—Designed for 9 to 12 hours of shorter wear time without extended treatment duration versus the standard 22 hours required by leading aligner brands (according to OrthoFX)*.
• Greater Movement Efficiency—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*.

• Predictable Precision—Designed for better predictability and compliance, 92% of NiTime Aligner treatments were completed without refinements*.

Nearly Eliminates Refinements—Standard leading aligners exhibit a 14% predictability of tooth movement compared to the treatment plan. OrthoFX says NiTime’s AirShellTM Technology demonstrated an 86% predictability, nearly eliminating the need for refinements throughout the entire treatment plan*.

• Patented & FDA-cleared—The new clear aligners are the first and only FDA-cleared aligner optimized explicitly for shorter wear time*.
• Patented HyperElasticTM polymer maintains biologically favored force levels, allowing predictable tooth movement with only 9 to 12 hours of wear time.

o The HyperElastic polymer featuring AirShell technology is designed to provide sustained optimal forces delivery, supporting natural bone tissue remodeling at its natural pace to straighten teeth and to compensate against daytime relapse.

o NiTime Aligners are meticulously designed to support favorable cellular physiology, fostering an ideal environment for biological tissue remodeling, the company states. This process involves the orchestrated activity of osteoclasts and osteoblasts, the key cells responsible for bone remodeling, ensuring optimal treatment outcomes.

While clear aligners became a mainstream orthodontic modality in the late 1990s, one obstacle preventing consistent effectiveness is a lack of compliance. Patient compliance with clear aligners continues to be a problem for patients due to interference with eating, drinking, and for some patients–speech challenges–throughout their day.

“OrthoFX has disrupted the orthodontic industry by developing a real solution for lack of patient compliance with their NiTime Clear Aligners,” adds Dr. Neil Warshawsky, in this week’s press release. “Their distinctive and patented method, from polymer formulation to aligner design to manufacturing processes, effectively mitigates drastic drops in appliance pressure. 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 almost feel no discomfort while in treatment. I am seeing outcomes consistent with my treatment plans without the need for multiple refinements.”

The NiTime Aligner nightwear system became available to a limited group of orthodontic practices last year, but is now available nationwide for clinicians to provide patient treatment.

For additional information on the aligners and to see how the technology works, you can watch the OrthoFX NiTime Explainer Video here.

*Data on file at OrthoFX