Definition and recommendations for trial methods for evaluating dentin hypersensitivity: A hybrid AI‐assisted scoping review and Delphi consensus process

BACKGROUND: Dentin hypersensitivity (DH) is a common yet inconsistently defined condition impacting oral health and quality of life. Variability in diagnostic criteria and trial methodologies has limited comparability of previous research. OBJECTIVES: To map current definitions, diagnostic frameworks, and clinical trial methodologies in DH research. Assess alignment with current best practice guidelines and CONSORT reporting standards. Establish a consensus-based DH definition and core outcome set to guide future trials. METHODS: A scoping review was conducted in accordance with the PRISMA-ScR framework examining DH definitions published post-1997 and design of randomized controlled trials (RCTs) over the last 5 years. A hybrid AI-assisted and manual data extraction approach was employed maximizing efficiency and rigor. Data were retrieved on definitions, diagnostic criteria, stimuli, outcomes, and design features. Quantitative summaries and thematic syntheses were generated for two domains: (i) definitions and diagnostic criteria (ii) trial design, stimuli, and outcomes. RESULTS: Definitions of DH varied widely in the 72 included papers. Few studies incorporated all elements of the currently accepted definition, particularly with respect to exclusion of alternative pathologies. Recent literature introduced patient-centered and mechanistic extensions to the definition. Among 58 RCTs, CONSORT adherence was inconsistent, especially reporting of randomization, blinding, and effects estimates. The Delphi study achieved consensus on a refined case definition, minimum diagnostic criteria, validated assessment tools, and core outcome set (COS) encompassing clinician assessed, patient reported, and QoL measures. CONCLUSIONS: Substantial conceptual and methodological variation persists in DH research. The consensus-derived definition and COS offer foundations for standardized, high quality DH trials aligned with current evidence and patient priorities. PROTOCOL REGISTRATION: This protocol was registered a priori with Open Science Framework (OSF) - (https://doi.org/10.17605/OSF.IO/J6D7N). The scoping review was reported according to the PRISMA Extension for Scoping Reviews (PRISMA-ScR).