Abstract
The dental explorer medical device assists multiple functions, including marginal assessment. The working tip quality is a factor affecting operator judgement. However, little data exists to demonstrate the actual quality of working tips in clinical practice. The purpose of this study is to investigate and quantify if any real, measurable differences of the explorer working tip dimension exist among such instruments currently in service and compare to published medical device industry standards. Twenty new #23 dental explorer instruments from two manufacturers served as controls and sixty-three instruments in circulation at a dental school clinic were observed using light microscopy. The instruments were measured 50 micrometers from the terminus. A One-Way ANOVA was performed to analyze values among groups. No statistically significant difference between the mean working tip dimensions of new instruments was detected between brands. However, statistically significant differences between new and used instruments were detected, regardless of brand. The range (92.5-227.5 micrometers) detected near doubling in width of the used working tips compared to new working tips. The average used instrument tip is 50% wider than the average new instrument. These findings imply other studies employing a dental explorer may be confounded if the instrument is not measured. Furthermore, the results of this study should serve as a motivating factor towards future research to update quality standards regarding the medical device with a goal of defining acceptable dimensions of the instrument working tip for certain applications in relation to clinical performance and expected outcomes.
