In vitro evaluation of bioburden, three-dimensional stability, and accuracy of surgical templates without metallic sleeves after routinely infection control activities

Abstract

Background: Surgical templates are classified as noncritical devices, and they do not need to be sterile. Aim: Primary aim of this study was to assess the microbiological burden present on the surgical templates without metallic sleeves after disinfection. Furthermore, to evaluate trueness after disinfection and steam sterilization at 121°C/15 min, and over a 8-week storage period. Finally, to assess their accuracy after in vitro implant placement simulation. Materials and methods: Forty surgical templates were printed and divided in five groups of eight templates each. Groups A to C were disinfected with 0.5% Chlorhexidine Gluconate and 70% ethyl alcohol base solution for 15 min. Templates in the group D were steam sterilized at 121°C for 15 min, while, the templates in the group E were used as control. Implant simulation was performed in the group A. Outcome measures were determination of bioburden, trueness assessment using GOM Inspect Professional software, and accuracy evaluated thought the mean angular deviation of simulated implants. Results: Total microbic charge measured as colony forming units (CFU) for sample, was 24.40 in the control group (group E; n = 8), and <4.40 in the test group (group C; n = 8), with a reduction of 84%. Colored representation from GOM inspection showed no differences after disinfection and implant simulation, disinfection alone, and steam sterilization, compared to the control group. A very small difference in the surface and volume dimensions was reported 1 month after templates fabrication. The mean roundness tolerances of the tested templates improved of 0.96 ± 0.56° (95% CI 0.57–1.35). Conclusion: Surgical templates without metallic sleeves can be safely used after disinfection, demonstrating high level of accuracy, even when the surgical procedures should be postponed within a couple of weeks. Further in vivo study are needed to confirm these preliminary results.