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 been cleared by the US Food and Drug Administration to promote Glidewell’s bactericidal and fungicidal properties.^™ Material 3DP Denture Base Resin.

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

Less bacteria and fungi on the surface of the printed denture can lead to 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 eliminate the most commonly found oral bacteria and fungi.”

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

Microorganisms tested in vitro included Streptococcus mutans, Streptococcus mitis, Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, Candida albicans, Candida glabrata, Candida tropicalisand common super bugs like MRSA (Methicillin-resistant Staphylococcus aureus) and VRE (Enterococcus resistant to vancomycin) known to cause serious infections in hospitals and intensive care units, especially with the elderly. These bacteria and fungi have been shown to lead to diseases such as denture stomatitis and build up as nettle biofilms on the surface of an imprinted denture.¹

According to the American College of Prosthodontists, approximately 36 million adults in the United States suffer from periodontitis, and 120 million are missing at least one tooth.² About 90% of this population uses dentures to replace teeth and restore function.³ Glidewell addresses this need with a full range of traditional and 3D dentures that clinicians can prescribe.

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

References

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 Numbers”. American College of Prosthodontics, Oct. 2024. https://www.gotoapro.org/facts-figures/
3. Ibid.

Source: Glidewell Dental