Dental Research in the Digital Age: The Registry-Based Clinical Trial.

Abstract

With the global increase in the volume of digital health data recorded and accessible through national and institutional databases, such as clinical registries and evidence-based registries, new strategic approaches are now feasible in medical research. These approaches include the registry-based clinical trial (RBCT) design, where large-scale datasets-which grow exponentially over time (referred to as big data)-can be used to identify eligible study participants from a medical registry containing trial-specific inclusion criteria. The RBCT approach may also be used to establish historical control groups for prospective interventional studies that enable rapid recruitment with a lower study budget, while providing high statistical power. Hence, obstacles frequently encountered when conducting randomized controlled trials, such as difficulties in recruiting a sufficient sample size in a reasonable time period, may be overcome for specific research questions. This innovative study design of an RBCT aims to combine the external validity of medical registries with the internal validity of the traditional study designs, and has the potential to influence clinical decision making and healthcare policy. The aim of this perspective article is to describe this new methodological approach and to critically analyze the future possibilities and challenges of RBCTs in dental and implant research.