Qualitative and quantitative analysis of the elements of endodontic chelator and antibacterial solutions by inductively coupled plasma-mass spectrometry method

ABSTRACT Title: Qualitative and quantitative analysis of the elements of endodontic chelator and antibacterial solutions by inductively coupled plasma-mass spectrometry method. Aim: To aim was to carry out qualitative and quantitative multi-analytical experiments on medical devices containing ethylenediaminetetraacetic acid (EDTA, MDR EU/2017/745 Class IIa) and Chlorhexidine digluconate (CHX, MDR EU/2017/745 Class III) and their counterparts that are available in the dental markets. Material and Methods: Multi-spectroscopic and analytic methods were used in the experiments: Inductively coupled plasma mass spectrometry (ICP-MS) was performed to detect the quantitative ion content of the solution media. Hydrogen potential measurements were conducted of the solution media (pH). Ultra-High-Performance Liquid Chromatography (UHPLC), Proton nuclear magnetic resonance spectroscopy (1H-NMR), energy dispersive X-ray spectroscopy (EDS), and X-ray Diffraction analysis (XRD) were performed due to assess the active components of the devices. Results: The results of ICP-MS, pH and EDS were shown in the cross-tables. The results of XRD, UHPLC, and 1H-NMR analysis were made via the interpretations of the diffractograms, chromatographies, and spectroscopies. Conclusions: Tested counterparts had significant results which could have potential risks to public health and their expected treatment efficiencies: • The EDTA counterparts' chromium, Antimony, Aluminum, Iron, Nickel and Lead content were above the threshold level declared by World Health Organisation. A high amount of chromium was noted in EDTA control. Also, a high amount of lead and iron was noted in CHX control. • UHPLC, XRD, EDS, and 1H-NMR analyses support the conclusion that the chemical structure of the active ingredient in the CHX control differs from its counterparts. The amount of active ingredients for tested CHX counterparts has been questionable. • XRD, EDS, and 1H-NMR analyses support the conclusion that the chemical structure of the active ingredient in the EDTA control differs from its counterparts. • EDTA control has buffered pH neutrally, whereas tested counterparts are highly alkaline. Keywords: Chlorhexidine, chromatography, EDTA, Endodontics, medical device regulations, spectroscopi