Glidewell Receives FDA Clearance for Antimicrobial Denture Resin

NEWPORT BEACH, Calif., October 15, 2024 (Newswire.com) - Glidewell, America’s largest and most innovative dental laboratory, announced today that its ISO-certified manufacturing division Prismatik Dentalcraft, Inc. has received clearance from the U.S. Food and Drug Administration to promote the bactericidal and fungicidal properties of its Glidewell^™ 3DP Denture Base Resin material.

Under in-vitro test conditions, dentures fabricated from this proprietary 3D-printing resin have exhibited a >99.9% reduction in the most common bacteria and fungi known to cause biofilm and contamination of a denture surface, providing specific, long-term antimicrobial effectiveness.

Less bacteria and fungi on the surface of the printed denture can result in a “cleaner” denture, with fewer microorganisms colonizing. This can lead to longer denture life, and a more pleasant overall experience for the patient. 

“We produce thousands of dentures annually and see firsthand the negative effects of bacteria and fungi on the denture surface,” said Raj Malyala, Vice President of Materials Research & Development at Glidewell. “We challenged our scientists and development teams to identify and implement a solution that would eradicate the most commonly found oral bacteria and fungi.”

The formulation for the Glidewell 3DP Denture Base Resin contains silver sodium hydrogen zirconium phosphate as the antimicrobial agent. Led by Maggie Liu, Ph.D., a team of researchers conducted extensive non-clinical, in vitro testing to evaluate the activity of the incorporated antimicrobial agent, per ASTM E2180-07 and ASTM E2647-13 test methods. The company plans to conduct clinical studies to determine whether the presence of silver sodium hydrogen zirconium phosphate results in improved outcomes.

Microorganisms tested in vitro included Streptococcus mutans, Streptococcus mitis, Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Candida albicans, Candida glabrata, Candida tropicalis, and common super bugs such as MRSA (Methicillin-resistant Staphylococcus aureus) and VRE (Vancomycin-resistant Enterococcus) that are known to cause severe infections in hospitals and intensive care units, especially with the elderly. These bacteria and fungi have been shown to lead to disease states such as denture stomatitis and accumulate as nettlesome biofilm on the surface of a printed denture.¹

According to the American College of Prosthodontics, approximately 36 million adults in the United States suffer from edentulism and 120 million are missing at least one tooth.² Around 90% of that population uses a denture to replace teeth and restore function.³ Glidewell serves this need with a full range of traditional and 3D-printed dentures for clinicians to prescribe.

To learn more about the Glidewell 3DP Denture Base Resin or additional denture services like Simply Natural^™ Digital Dentures, visit glidewell.com.

Citations

1. Gendreau, Linda, and Zvi G. Loewy. "Epidemiology and etiology of denture stomatitis." Journal of Prosthodontics: Implant, Esthetic and Reconstructive Dentistry 20.4 (2011): 251-260. Epidemiology and Etiology of Denture Stomatitis - Gendreau - 2011 - Journal of Prosthodontics - Wiley Online Library.
2. “Facts and Figures.” American College of Prosthodontics, Oct. 2024. https://www.gotoapro.org/facts-figures/ 
3. Ibid.

Source: Glidewell Dental