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

摘要

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 3.3mm 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 3.3mm 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±0.54mm (-0.32±0.61mm and -0.34±0.63mm mesial and distal, respectively). Patients had healthy peri-implant soft tissues, as indicated by mean probing pocket depths ranging from 2.21 to 2.89mm 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.