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

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

by adminjay



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.


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.


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).


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.

Key Words

Abbreviation Key:

ADA (American Dental Association), ARS (Alizarin red S), B (Negative sample control), BSA (Bovine serum albumin), FDA (US Food and Drug Administration), JWG (Joint Working Group), NC (Negative instrument control), OPA (O-phthaldialdehyde), S (Positive instrument control), SC (Test instrument), SEM (Scanning electron microscopy), TS (Positive sample control)

A variety of dental instruments are used in the daily practice of dentistry. These dental instruments can be single-use (disposable) and multiuse (reusable). A disposable device is intended to be used on 1 patient during a single procedure, and it is not intended to be reprocessed and used on another patient, as defined by the US Food and Drug Administration (FDA)


US Food and Drug Administration
What are reusable medical devices?.