Avaliação do desempenho e da longevidade clínica de coroas monolíticas de cerâmica infiltrada por polímero: ensaio clínico controlado e randomizado

Abstract

Objective: To evaluate through a controlled, randomized, double-blind clinical trial the clinical performance of posterior monolithic crowns made of polymer-infiltrated ceramic, as well as the impact of rehabilitation on patients' aesthetic satisfaction and quality of life. Materials and Methods: A total of 30 patients who received 47 crowns were included in this study. All patients signed the informed consent form. The teeth undergoing rehabilitation were allocated through a simple draw between the groups: Control Group (LD - lithium disilicate) and Experimental Group (PIC - Vita Enamic/Vita Zahnfabrik). Photographic, radiographic, and clinical data were collected before, during, and after rehabilitation. The crowns were assessed for clinical survival rate (modified USPSH criteria), aesthetic satisfaction (Visual Analog Scale - VAS), quality of life (Oral Impacts on Daily Performances - OIDP), and types of failures (biological and technical). Data collection was performed by a single examiner who was calibrated and blind to the material type, at follow-up times T0 (before treatment), T1 (1 month), T2 (6 months), T3 (12 months), T4 (24 months), T5 (36 months), T6 (48 months), T7 (60 months), and T8 (72 months). OIDP and USPSH criteria were analyzed descriptively. Aesthetic satisfaction was analyzed with Mann-Whitney/Friedman Test/ Wilcoxon post-tests. Survival analysis was conducted using Kaplan-Meier followed by the log-rank test. The significance level was set at 5%. Results: 47 crowns were installed in 30 patients, with 22 (46.8%) in the control group (LD) and 25 (52.3%) in the experimental group (PIC). Kaplan-Meier analysis revealed a survival rate of 88.0% for PIC and 95.5% for LD with no significant differences between them (P>0.05). Four failures were recorded, including three debondings(2 from PIC after 1 month and 36 months, and 1 from LD after 6 months) and one crown fracture (PIC) after 24 months of follow-up. There was a significant difference in aesthetic satisfaction between the control and experimental groups (Mann-Whitney - P>0.05) regarding color, aesthetic satisfaction, and natural appearance after T5 (36 months). Aesthetic satisfaction was significantly higher after 1 (T1), 6 (T2), 12 (T3), 24 (T4), 36 (T5), 48 (T6), and 60 (T7) months compared to baseline (T0) (Friedman Test – P - P<0.05). Conclusion: This study demonstrates that monolithic single crowns of PIC showed clinical performance, aesthetic results, and a positive impact on patients' quality of life similar to LD after 72 months.