Estudio clínico prospectivo del comportamiento de un ionómero de vidrio evaluado mediante impresión óptica

Abstract

TITLE: Prospective clinical study of glass ionomer's behaviour using intraoral scanners. INTRODUCTION: Controlling the variables that affect restorations is crucial for their success and longevity. In addition to secondary caries tooth wear has proven to be one of the causes of restoration deterioration, causing premature failure and thus shortening the average life of a restoration. Tooth wear is a multifactorial condition with an increasing incidence worldwide. Therefore, it is necessary to develop methods for its early diagnosis and active surveillance. Among existing methods, different visual indices provide qualitative data. Wear is difficult to detect and monitor through the human eye, and because of the subjective nature of visual indices, they are more frequently used in epidemiological studies. These limitations favourthe search for new methods that provide quantitative data and can be applied in daily clinical practise. Published in vitro studies have proposed intraoral scanners as reliable tools for early wear detection, monitoring, and quantification of tooth wear. OBJECTIVES: This in vivo study aimed to determine the efficacy and clinical performance of a glass ionomer restorative material (KetacTM Universal Quik Aplicap) compared to a traded glass ionomer restorative material (KetacTM Molar Quick Aplicap). Furthermore, the study evaluated the clinical survival and quality of the restorations, as well as wear behaviour, at different observation times (TO, T6, T 12, and T24). Finally, the concordance and correlation between visual and digital methods for measuring wear were analysed. MATERIAL AND METHOD: The study consisted of a sample of 39 patients who received two restorations (one from the test group (KU) and the other from the control group (KM)) on randomly selected molars and premolars. Throughout the course of the study, at each observation time point, the restorations were evaluated in a blinded manner by two independent evaluators through a visual index (Peters Index) and ST L file overlay analysis. Of the seven variables analysed (fracture/retention of the restoration, marginal adaptation/chipping, superficial or marginal staining, wear of the filling material, postoperative sensitivity or pulp involvement, caries adjacent to the restoration (CAR), and dental integrity), only the wear variable was analysed quantitatively. For this purpose, ST L file superimposition software was used at different observation times, which made it possible to superimpose the different optical impressions taken during the study in a protocolised manner. RESULTS: In regards to the survival of the restorations, there were no statistically significant differences between the KM and KU groups at the 4 observed time points (p=2.727). There were also no statistically significant differences between the two materials in regards to restoration quality and restoration wear. In the digital measUrement Of wear, the control group presented with higher values (279.0 [357.81) than the test group (254.0 [213.0]), with no statistically significant differences between the two groups (p=0.350) at the first Observation time point. Regarding clinical behaviour, 22 restorations in the KU group and 26 restorations in the KM group were clinically unacceptable during the observation period TO-T6. The differences between the two groups were not statistically significant (p=0.599). During the second observation period (T6-T12), wear in the control group (73.5 [223.3]) was found to be lower than in the test group (145.5 [266.0]), with no statistically significant differences between the two groups (p=O.018). At this time point, 22 restorations in the KU group and 22 restorations in the KM group were considered to be clinically unacceptable. Similarly, there were no statistically significant differences between the groups (p=O.237) during the second observation time (T6-T12). Based on the analysis of the concordance between measurement techniques for wear (visual versus digital), no agreement was obtained in the two analysed time periods: TO-T6 with kappa(k)= 0 1 000 and T6T12 with k=O'0030. Discordant results were observed in the correlation analysis. According to the data analysed during the first observation period (TO-T6), the results were not considered statistically significant (p=O.838), but those obtained during the second observation time (T6-T12) were considered statistically significant (p 0.001). CONCLUSIONS: Within the limitations of this study, it can be concluded that the overall survival in terms of efficacy and performance of the restorations was similar in both groups, showing no statistically significant differences between KetacTM Universal and KetacTM Molar Quick Aplicap during the 24 months of follow-up. In addition, the quality of the restorations according to the FDI/Peters criteria was similar for both materials, showing no statistically significant differences between KetacTM Universal and KetacTM Molar Quick Aplicap at 6, 12 and 24 months. The wear of the restorations evaluated by the intraoral scanner showed clinically unacceptable levels for both materials according to the annual wear limits proposed by the ADA. Finally, there was no agreement in the concordance between the visual and digital methods for the analysis of wear at all observed times. Regarding their correlation, there were no statistically significant differences during the first six months, but there were significant differences between six and 12 months. Further in vivo studies are required to confirm these results.