Validating cleanability of dental rotary diamond instruments soiled with 2 clinically relevant dental test soil components

Abstract

Background: The aim of this study was to produce a dental test soil, with 2 clinically relevant soil components, to be quantified for cleaning process validation. Another goal was to soil diamond instruments with the 2 soil components and validate the efficacy of cleaning instructions, developed and detailed in this study, using both qualitative and quantitative techniques.

Methods: To simulate worst-case clinical use conditions, the authors used each soiled instrument to prepare a 9-millimeter-deep access cavity on a noncarious extracted molar. Afterward, the authors applied a mixture of pooled human saliva and blood test soil to each instrument and air-dried it for 30 minutes. The authors cleaned each instrument using documented multistep cleaning instructions, which were then validated via both qualitative and quantitative assessment of protein and enamel-dentin residues using spectrophotometric analysis and microscopy images.

Results: After thorough cleaning, neither protein nor enamel-dentin residues were found at quantifiable levels (spectrophotometric analysis) on the soiled and cleaned diamond instruments, which was qualitatively verified (microscopy images).

Conclusions: The results of this study show the successful development of a dental test soil with 2 clinically relevant soil components. Furthermore, using these soil components as test markers, the authors found that when the established cleaning instructions are properly followed, a soiled diamond instrument can be cleaned in a quantifiable manner.

Practical implications: Thorough cleaning is a critical step in reprocessing multiuse dental instruments. In accordance with US Food and Drug Administration guidance, the described process for quantification of soil components, using 2 clinically relevant soil markers, on cleaned diamond instruments can be helpful to dental instrument manufacturers in the development and validation of cleaning instructions for their reusable instruments.

Keywords: FDA; Reprocessing; cleanliness; dental instruments; dental soil; multiuse; rotary instruments; single-use.