Engineering start-up company receives go-ahead from FDA for dental filling composite
Got cavities? In the near future, a product developed by a University of Missouri (MU) mechanical engineering professor and his company may be what your dentist uses to fill them.
Hao Li is a professor in the Mechanical and Aerospace Engineering Department, as well as president of Nanova Biomaterials Inc. (NBI). The company recently received approval from the Food and Drug Administration to market and sell its nanofiber-reinforced flowable composite, NovaPro Flow, which will be used for dental repairs, namely restoration fillings.
Many of the current flowable dental composites use nanoparticles, mainly because, unlike composites using glass or carbon fibers, they provide a certain level of strength while retaining the ability to be polished to the quintessential dental shine. Li sought to create a composite using nanofibers with nanoparticles that would both significantly improve strength and still retain the shine.
“For carbon fibers, one reason they become stronger is, theoretically, their strength is in inverse proportion to the square root of their diameter,” Li said. “This means if the diameter shrinks 100 times, the strength goes up 10 times. Basically, it tells us that if the fibers get thinner, they become stronger.”
It is better if there are fewer defects in the nanofibers, he added.
NovaPro Flow is applied as a flowable composite through a syringe and with the right viscosity can be easily and precisely delivered into the mouth of patient. Once the composite is fitted to the cavity properly, it is cured with a blue light, which hardens it in less than 20 seconds.
Once hardened, the nanofibers can be compared to rebar in concrete, providing support to the overall structure and ensuring greater longevity than other composites currently on the market. Using NBI’s dental composites, patients can go longer before it is necessary to replace their fillings.
NBI’s research results, concluded during the FDA approval process, illustrate that NovaPro Flow has higher flexural strength and micro-tensile bond strength than its major competitors, as well as less shrinkage stress. And NBI’s composite is among the best on the market in terms of compressive strength. Notably, the NovaPro Flow is even stronger than most of the universal dental composites in the market.
“We tested our composite against all other commercial [dental filling] products,” Li said. “It’s stronger than anything else we have on the market.”
Funding for the research was provided by Li’s 2009 National Science Foundation CAREER award, which totaled approximately $430,000, and another approximately $410,000 grant from the National Institutes of Health. A Chinese venture capital firm, SummitView Capital, provided additional funding for mass production and the lengthy FDA approval process as part of its more than $7 million investment in the company.
“The approval process takes about 3-6 months if everything goes right,” Li said. “It took us, I think, over a year to prepare the application, because we had to do all kinds of testing. We have long documentation, and basically safety and efficacy are the two things the FDA is looking for.”
Li said NBI is working on gaining FDA approval for more nanofiber-based biomaterials, including universal dental composites and orthopedic screws. The company already made a notable splash in the dental industry with its dental varnish, StarBright. NBI opened its Columbia facility in 2013, where it currently manufactures all of its innovative nanofiber products.
For additional information, please watch the MU News Bureau video below.