# Dental Research in the Digital Age: The Registry‐Based Clinical Trial

**Authors:** Tim Joda, Eugenia Settecase, Lisa Heitz‐Mayfield, Jan Derks, Ronald E. Jung, Nicola U. Zitzmann

PMC · DOI: 10.1111/clr.70061 · Clinical Oral Implants Research · 2025-10-24

## TL;DR

This paper introduces a new research method called registry-based clinical trials that uses big data to improve dental and implant research efficiency and validity.

## Contribution

The paper presents the registry-based clinical trial as a novel method to enhance dental research through big data and improved study design.

## Key findings

- Registry-based clinical trials can rapidly recruit participants and reduce study costs while maintaining statistical power.
- This approach combines the strengths of medical registries and traditional study designs for better external and internal validity.
- RBCTs offer potential to overcome recruitment challenges in randomized controlled trials for specific research questions.

## 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.

## Full-text entities

- **Diseases:** caries (MESH:D003731), type 1 and type 2 diabetes (MESH:D003924), tooth loss (MESH:D016388), cRBCTs (MESH:D019292), diabetes (MESH:D003920), periodontal disease (MESH:D010510), peri-implantitis (MESH:D057873)
- **Species:** Homo sapiens (human, species) [taxon 9606]

## Full text

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## Figures

5 figures with captions in the complete paper: https://tomesphere.com/paper/PMC12875361/full.md

## References

35 references — full list in the complete paper: https://tomesphere.com/paper/PMC12875361/full.md

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Source: https://tomesphere.com/paper/PMC12875361