The National Dental Practice-Based Research Network Dental Implant Restoration Registry: A Protocol for a Prospective Observational Study of Dental Implant Outcomes in Community Practice Settings (Preprint)

BACKGROUND Dental implants are a widely used therapeutic option for tooth replacement; however, biological and prosthetic complications may compromise implant success. While prior research has largely focused on academic or specialty settings, data on implant outcomes in community dental practices remain limited. OBJECTIVE This study aims to establish a national registry within the National Dental Practice-Based Research Network (PBRN) to evaluate the incidence and factors associated with biological and prosthetic complications following implant therapy in community practice settings. METHODS This prospective, observational cohort study will enroll approximately 1550 patients receiving implant restorations from 150 practitioners across six regional PBRN nodes. A total of 2,000 implant restorations will be longitudinally monitored over three years. Clinical, implant, and prosthetic characteristics will be recorded at baseline, with annual follow-up visits collecting data on complications, implant failures, prosthetic issues, and patient-reported outcomes. Digital radiographs will be centrally reviewed for peri-implant bone changes, emergence angle, and prosthetic fit. The primary outcome is the incidence of biological and prosthetic complications. Secondary analyses will evaluate patient-centered outcomes and identify risk factors for complications. Advanced statistical models, including multilevel mixed-effects regression and time-to-event analyses, will be employed to account for clustering and censored data. RESULTS - CONCLUSIONS This registry will generate robust, real-world evidence on implant-related complications and their predictors in community practice. The findings will enhance clinical decision-making, support personalized risk assessment, and ultimately improve patient outcomes in implant dentistry. CLINICALTRIAL