FDA approves Dentalpoint AG's Zeramex XT ceramic implants

Patients increasingly indicate that they prefer metal-fee solutions for dental implants as they seek to mimic the look and biological compatibility of natural teeth. ZERAMEX^® XT offers patients the biological, soft tissue and esthetic benefits of ceramic implants with the modern design and ease of use of a two-part implant with a cement-free internal connection and tapered body.

DentalPoint, the pioneer in two-piece ceramic implants, has received FDA approval for their latest product – ZERAMEX^® XT. The ZERAMEX^® XT system is a 100 percent metal-free alternative to titanium implants designed for highly cosmetic tooth replacement, especially in the esthetic zone. Dental professionals will now reportedly be able to use a two-piece ceramic implant with a reversible screwed internal connection that supports a natural soft-tissue appearance. ZERAMEX^® XT was developed for outstanding soft-tissue attachment and low inflammatory response.¹ The white zirconia material especially benefits patients with a thin mucosal biotype.² Zirconia implants demonstrate a low affinity to plaque³ and studies have shown that microcirculatory dynamics in peri-implant mucosa around zirconia are comparable with those around natural teeth.⁴

The ZERAMEX^® XT ceramic implant is manufactured from high-strength ceramic Bio-HIP ATZ. The hard zirconia material with the color and translucence of natural teeth is manufactured by hot isostatic pressing. No thermal process (sintering) or post-processing takes place after the final shaping of the outer and inner geometry of the implant. This ensures that a high degree of precision is achieved, and no further changes can occur in the material structure.

ZERAMEX^® XT is said to offer greater restorative flexibility compared to one-piece or cemented ceramic implants. The reversible screwed internal connection is a unique differentiation to existing systems on the market. The extremely hard ceramic is combined with an ultra-strong, 100 percent metal-free, high-performance VICARBO^® carbon fiber screw that stabilizes tensile forces. Risk of excess cement during the procedures, which are often associated with soft tissue inflammation and the development of peri-implantitis, can be avoided.⁵

“ZERAMEX^® XT is a breakthrough in the development of an equal performing ceramic implant compared with traditional implants. But on top of that it offers all of the benefits based on the material. We are convinced that ZERAMEX^® XT is the right product to answer the recent trend of patients preferring metal-free dental implants,” says Adrian Hunn, VP marketing and sales DentalPoint AG, Zurich, Switzerland.

The implant shape and thread design of ZERAMEX^® XT have been developed to achieve high primary stability. The ZERAFIL™ surface is a micro-structured implant surface that reportedly enables decisive osseointegration of the dental implants. The success rate of ZERAMEX^® ceramic implants with a ZERAFIL™ surface is said to be between 96.7 and 98.5 percent, depending on the system, and bears witness to the decisive osseointegration thanks to the optimum surface structure.⁶ The hydrophilic implant surface ZERAFIL™ is sandblasted and etched so that osteoblasts can grow directly up to the dental implant and firm adhesion to the implant surface is achieved. The ZERAMEX^® XT ceramic implant is placed 1.6 mm supracrestally (optionally up to 0.6 mm) and is engineered to offer great prosthetic flexibility. The implant thread was developed to achieve high primary stability. The reservoir for bone chips at the implant tip reportedly simplifies the placement of the implant.

ZERAMEX^® XT and ZERAMEX^® P6 systems are available for sale through distribution partner, Emerginnova.  Michael Foley, president of Emerginnova, says, “XT allows implant clinicians to confidently offer ceramic implants to meet their patients demands while respecting the most modern designs, workflow and treatment planning that they expect.”

First customer shipments are scheduled for Dec. 14. Introductory launch packages, including loaner use of surgical kits, are now available for pre-delivery purchase.

References

1 Cionca N, Hashim D, Mombelli A. Zirconia dental implants: where we are now, and where are we heading? Periodontol 2000 2017; 73(1):241-258

 2 Cosgarea R, Gasparik C, Dudea D, et al. Peri-implant soft tissue colour around titanium and zirconia abutments: a prospective randomized controlled clinical study. Clin Oral Implants Res 2015;26(5):537-544

3  Cionca N, Hashim D, Mombelli A. Zirconia dental implants: where we are now, and where are we heading? Periodontol 2000 2017; 73(1):241-258
   Scarano A, Piattelli M, Caputi S, et al. Bacterial adhesion on commercially pure titanium and zirconium oxide disks: an in vivo human study. J Periodontol 2004;75(2):292–296

4 Kajiwara N, Masaki C, Mukaibo T, et al. Soft tissue biological response to zirconia and metal implant abutments compared with natural tooth: microcirculation monitoring as a novel bioindicator. Implant Dent 2015;24(1):37-41

5 Wilson TG Jr. The positive relationship between excess cement and peri-implant disease: a prospective clinical endoscopic study. J Periodontol 2009;80(9):1388-1392

6 Chappuis V, Cavusoglu Y, Gruber R, Kuchler U, Buser D, Bosshardt DD. Osseointegration of Zirconia in the Presence of Multinucleated Giant Cells. 2016 Aug;18(4):686-98. doi: 10.1111/cid.12375. Epub 2015 Sep 17.