Akademik Veri Yönetim Sistemi
16.International Congress of Turkish Endodontic Society, Antalya, Türkiye, 25 - 28 Mayıs 2025, sa.24, ss.122-123, (Özet Bildiri)
Aim: This study conducts physicochemical characterization experiments on medical devices
containing chlorhexidine (CHX), 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 CHX (M1:MicroVem, M2:Werax, M3:Pyrax) from various manufacturers, classified as
Class III 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
(European Pharmacopoeia, Reference Standard, Strasbourg Cedex, France). All analytical assays
were performed in triplicate(n=3). The purity of the solvent was evaluated through inductively
coupled plasma mass spectrometry (ICP-MS), the levels of CHX components were quantified
using Ultra-High-Performance Liquid Chromatography (UHPLC), the organometallic structure
of CHX was examined via Proton Nuclear Magnetic Resonance Spectroscopy (¹H-NMR), and
the elemental composition was assessed using Energy-Dispersive X-ray Spectroscopy (EDS).
ANOVA was utilized for data analysis, followed by the Tukey HSD post-hoc test (p=0.05).
Results: ICP-MS characterization revealed contamination levels according to WHO water
standards, with iron and lead detected in one control sample. The pH levels of M1 and M2
groups showed statistically significant differences compared to the control (p<0.05). In UHPLC
characterization, a singlet peak at 254 mAU was observed for the 50-ppm reference at 4.826 s;
however, inconsistencies and low concentration levels were detected within and among the
alternatives. Precipitation occurred in all M2 samples. EDS characterization showed elemental
weight percentage differences and inconsistencies in C, N, O, Cl, and Na ion assignments
compared to the control. In ¹H-NMR characterization, spectral overlaps were observed for the
control, whereas chemical shifts in the 3.00–5.00 ppm range were detected in the alternative
groups.
Conclusion: The discrepancies in primary constituent composition of the evaluated alternative
products according to the control indicate a possible public health issue. Standardization of
these alternative devices is necessary. Further studies, including ex vivo and in vivo designs, are
urgently required to evaluate the therapeutic efficacy and adverse effects, particularly toxicity, of
these alternatives.