Randomized Controlled Trials Related to Behavioral Interventions in Dentistry

This chapter provides an overview of approaches, methodologies, implementation, guiding theories, and examples of Randomized Clinical Trials (RCTs) designed to test the efficacy of behavioral interventions to improve oral health. We have considered both behavioral interventions used alone and those used in support of—or parallel with—clinical interventions. Most behavioral RCTs employ theoretical models, or behavior change theory or approaches that help define expectations for how the interventions work, and establish tools to measure behavioral outcomes. Essential to the implementation of behavioral trials are detailed planning, financial considerations, and assurance of the reliability and validity of processes and outcome assessments, including the relevance and extent of community participation. The main gap in behavioral interventions is a lack of understanding of behavioral models and theories; the lack of detailed study protocols and common language further complicates this understanding. To improve progress in the conduct of clinical trials of behavioral strategies, we must update our conceptual and methodological knowledge. This includes translating the behavioral strategy from the psychological literature into the specific applied oral health context and developing successful approaches to addressing the challenges of implementation. This chapter provides some guidelines for managing real-world challenges and describes successfully employed solutions to challenges in the implementation of behavioral RCTs.