RESUMEN
BACKGROUND: One of the responsibilities of the dental profession is to protect and advance the well-being of the public through research of new pharmaceuticals and devices. The objective of this article is to present information about the scientific and regulatory process involved in the design and execution of randomized clinical trials. CONCLUSIONS: Dentists willing to serve as investigators in clinical trials--from Phase 1 to Phase 2 or Phase 3--need to be aware of the two main documents that contain the majority of guidelines and regulations governing clinical research: Title 21 of the U.S. Code of Federal Regulations and the guidelines for good clinical practice put forth by the International Conference on Harmonisation. CLINICAL IMPLICATIONS: Advancements in the frontiers of oral health science and the development of safe, innovative and effective treatment modalities are often the result of high-quality clinical research that is conducted by dental professionals. Knowledge of the research process, professionalism, scientific integrity and a detailed execution of the research plan are all required elements for a successful outcome.