In vitro validation of Digital Image Analysis Sequence (DIAS) for the assessment of the marginal fit of cement-retained implant-supported experimental crowns

Abstract

Abstract Background The replica technique with its modifications (negative replica) has been used for the assessment of marginal fit (MF). However, identification of the boundaries between prosthesis, cement, and abutment is challenging. The recently developed Digital Image Analysis Sequence (DIAS) addresses this limitation. Although DIAS is applicable, its reliability has not yet been proven. The purpose of this study was to verify the DIAS as an acceptable method for the quantitative assessment of MF at cemented crowns, by conducting statistical tests of agreement between different examiners. Methods One hundred fifty-one implant-supported experimental crowns were cemented. Equal negative replicas were produced from the assemblies. Each replica was sectioned in six parts, which were photographed under an optical microscope. From the 906 standardized digital photomicrographs (0.65 μm/pixel), 130 were randomly selected for analysis. DIAS included tracing the profile of the crown and the abutment and marking the margin definition points before cementation. Next, the traced and marked outlines were superimposed on each digital image, highlighting the components’ boundaries and enabling MF measurements. One researcher ran the analysis twice and three others once, independently. Five groups of 130 measurements were formed. Intra- and interobserver reliability was evaluated with intraclass correlation coefficient (ICC). Agreement was estimated with the standard error of measurement (SEM), the smallest detectable change at the 95% confidence level (SDC95%), and the Bland and Altman method of limits of agreement (LoA). Results Measured MF ranged between 22.83 and 286.58 pixels. Both the intra- and interobserver reliability were excellent, ICC = 1 at 95% confidence level. The intra- and interobserver SEM and SDC95% were less than 1 and 3 pixels, respectively. The Bland–Altman analysis presented graphically high level of agreement between the mean measurement of the first observer and each of the three other observers’ measurements. Differences between observers were normally distributed. In all three cases, the mean difference was less than 1 pixel and within ± 3 pixels LoA laid at least 95% of differences. T tests of the differences did not reveal any fixed bias (P > .05, not significant). Conclusion The DIAS is an objective and reliable method able to detect and quantify MF at ranges observed in clinical practice.