Evaluating the Fragility of Randomized Controlled Trials in High Impact Dentistry Journals: Protocol for a Methodological Review (Preprint)

BACKGROUND This study aims to assess the robustness of randomized control trials (RCTs) in the dental field by analyzing the fragility index (FI). The FI is a statistical measure defined as the smallest number of event changes needed to convert statistical significance (P< 0.05), of a binary outcome, to a not significant result. Previous studies have found that the results of many RCTs in medical disciplines are very fragile. However, there is limited literature examining the robustness of trials in dentistry. OBJECTIVE The primary objective of this study is to evaluate the fragility of RCTs in top dental journals using the FI. The secondary objective is to explore factors associated with fragility. METHODS We will identify RCTs from five high-impact dental journals namely, Periodontology 2000, International Journal of Oral Science, Journal of Clinical Periodontology, Journal of Dental Research, and Journal of Dentistry published between January 2019 and December 2024 reporting at least one primary binary outcome. We will estimate the FI and factors associated with FI will be assessed using regression analysis. RESULTS Screening and data extraction began in August 2025 and are expected to conclude by December 2025. Data analysis will be conducted in January 2026, and we anticipate submitting the results for publication by March–April 2026. CONCLUSIONS Dental practitioners rely on RCTs to guide patient care and treatment planning. Assessing the FI of trials allows us to determine the robustness of their results. By evaluating fragility, dental practitioners and policymakers can make more informed decisions on evidence based care and identify areas for further research.