Comparative analysis of medical device adverse event reporting forms forpatients and industries across various countries, and the introduction of a unified generic form for harmonization.

Introduction: This comparative study examines the complexities of adverse event reporting forms for medical devices across various nations. Despite rigorous clinical trials and surveillance techniques, variations persist in processes and data elements used to report adverse events. The study highlights the importance of standardizing adverse event reporting for medical devices and suggests a comprehensive 'Generic Adverse Event Reporting Form' to accurately determine causality.

The effect of varying thicknesses of mineral trioxide aggregate (MTA) and Biodentine as apical plugs on the fracture resistance of teeth with simulated open apices: a comparative study.

Background: This study evaluates the fracture resistance of apical plugs created from Biodentine and mineral trioxide aggregate (MTA) in thicknesses of 3 and 5 mm within simulated open apex tooth models.

Methods: Fifty human maxillary central incisors were obtained from a pool of freshly extracted teeth. In order to replicate open apices without cavity preparation, ten teeth in the control group received apical-to-coronal preparation with Peeso reamers.