Patient-reported outcomes in dental clinical trials: a cross-sectional study of the ClinicalTrials.gov registry

Introduction: Patient-reported outcomes (PROs) capture how patients feel and function, yet their use in dental trials is not well characterized at the point of registration. Methods: Cross-sectional study of interventional trials registered in ClinicalTrials.gov between 2018 and 2026 with stomatognathic conditions. A deterministic rule-based classifier identified PROs among primary and secondary outcomes, and trials were classified into dental specialties. Results: Of 6,799 retrieved trials, 6,079 were classifiable into a dental specialty. A PRO was included as a primary or secondary outcome in 2,783 trials (45.8%, 95% CI 44.5-47.0), and as a primary outcome in 1,569 (25.8%). The proportion ranged from 28.6% in periodontics to 68.6% in oral medicine and pathology; adjusted odds ratios versus periodontics were 6.08 (95% CI 5.17-7.15) for oral medicine and pathology and 3.36 (95% CI 2.78-4.06) for endodontics. Conclusions: Patient-reported outcomes are specified in less than half of dental trials and vary substantially by specialty, being least frequent in periodontics and implant dentistry; specialty-specific standards could promote patient-centred outcome selection.