Research Information System
16.International Congress of Turkish Endodontic Society, Antalya, Turkey, 25 - 28 May 2025, pp.124-125, (Summary Text)
Aim: This study aims to conduct physicochemical characterization experiments on medical devices
containing ethylenediaminetetraacetic acid (EDTA), a widely used traditional broad-spectrum
antiseptic in endodontic applications, utilizing multiple analytical methods.
Material and Method: In compliance with MDR/EU/2017/745, three alternative(M) products
containing EDTA (M1:Saver, M2:Werax, M3:Microvem) from various manufacturers, classified as Class II
medical devices but lacking “approved” status from international accreditation bodies, were prepared
for chromatographic and spectroscopic experiments. The analysis was conducted with an authorized
control(PPH Cerkamed, Stalowa Wola, Poland) and a pure reference standard (Sigma-Aldrich Chemie
GmbH, Germany). Samples were prepared for chromatographic and spectroscopic analyses. All
analytical experiments were conducted in triplicate (n=3). Solvent purity was assessed using Inductively
Coupled Plasma Mass Spectrometry (ICP-MS), and qualitative EDTA characterization was performed
via X-ray Diffraction (XRD). The organic structure of EDTA was examined using Proton Nuclear Magnetic
Resonance Spectroscopy (¹H-NMR), and Energy-Dispersive X-ray Spectroscopy (EDS) was employed
for elemental composition analysis. Data were analyzed using ANOVA and Tukey’s HSD post-hoc test
(p=0.05).
Results: ICP-MS characterization revealed impurity levels based on WHO water standards. Chromium
(Cr) and iron (Fe) contaminants were detected in the control sample, whereas M1 contained aluminum
(Al), Fe, and lead (Pb). M2 exhibited Cr, antimony (Sb), Al, Fe, and nickel (Ni), while M3 showed Cr, Al, Fe,
and Ni impurities. The pH measurements of the control (7.45 ± 0.02) significantly differed from those
of M1 (10.05 ± 0.24), M2 (12.93 ± 0.02), and M3 (12.22 ± 0.02) (p<0.0001). XRD analysis showed amorphous
diffraction pattern overlaps in the lyophilized control samples, whereas variations were observed in the
equivalent groups. EDS characterization indicated discrepancies in elemental weight percentages
(%wt) for C, N, O, Cl, Na, Cl, and Zn compared to the control. In ¹H-NMR characterization, while the
control spectra exhibited overlap, the equivalent groups showed peak shifts and intensity losses in
=N-CH₂-COOH and =N-CH₂-CH₂-N= signals, suggesting impurity presence.
Conclusion: The differences in active ingredient composition between the tested counterpart/-feit
products and the control pose a potential public health concern. Given that these local products are
currently in use, a need for standardization is evident. To fully understand their therapeutic efficacy and
side effects, particularly their toxicity, urgent ex vivo and in vivo research data are required.