A pilot study to evaluate the success and survival rate of titanium-zirconium implants in partially edentulous patients: results after 24 months of follow-up.

OBJECTIVES

Implants made from a new titanium-zirconium (TiZr) alloy (Roxolid) have shown good osseointegration with no adverse effects in animal studies. This single-cohort pilot study was performed to evaluate the performance and safe use of reduced-diameter implants made from this new TiZr alloy for the first time in human subjects, in a prospective case-controlled series.

METHODS

In two private specialist clinics, each of 22 patients received one 3.3 mm TiZr test implant with a Regular Neck Standard Plus design. The use of the new implant was restricted to the indications and protocol for the use of the existing 3.3 mm diameter regular-neck implant made from Grade IV titanium. The test implants were splinted to a standard Grade IV titanium Regular Neck implant with a fixed dental prosthesis.

RESULTS

Twenty of 22 patients had a successful and surviving implant at the 2-year follow-up; one study implant was lost 80 days after placement due to infection spreading from an adjacent tooth and one patient did not complete the 2-year assessment. The mean change in the functional bone level 2 years after loading was -0.33 ± 0.54 mm (-0.32 ± 0.61 mm and -0.34 ± 0.63 mm mesial and distal, respectively). Patients had healthy peri-implant soft tissues, as indicated by mean probing pocket depths ranging from 2.21 to 2.89 mm after 2 years.

CONCLUSIONS

Within the limits of this pilot study, the performance of the new implant material was safe and reliable. The new implants meet established success and survival criteria after 2 years.