Early Clinical Outcomes of a Simplified Guided Single-Implant Workflow for Mandibular Overdentures: A Prospective Translational Proof-of-Concept Study

Abstract

Background/Objectives: The present study evaluated the early clinical outcomes and translational proof-of-concept of a simplified guided single-implant workflow for mandibular overdenture rehabilitation in edentulous patients. Methods: A prospective translational clinical pilot study was conducted in 15 edentulous patients treated using a simplified flapless guided single-implant mandibular overdenture protocol. The workflow was designed to reduce procedural complexity while maintaining clinically applicable surgical and prosthetic integration under routine treatment conditions. All surgical procedures were performed by a single experienced operator. The study was conducted following institutional ethical approval and informed consent procedures. Clinical, radiographic, peri-implant, prosthetic, and patient-reported outcomes were evaluated during the 1-year follow-up period. Marginal bone loss, peri-implant clinical parameters, complications, implant survival, and Oral Health Impact Profile (OHIP-14) scores were assessed. Results: All planned surgical and prosthetic procedures were completed successfully, with no major intraoperative or protocol-related complications. Implant survival was 100% during the 1-year follow-up period. Mean marginal bone loss was 0.19 ± 0.21 mm at loading and 0.25 ± 0.28 mm at 1 year. Peri-implant clinical parameters remained favorable throughout follow-up. Significant improvement in patient-reported quality-of-life outcomes was observed, with OHIP-14 scores demonstrating substantial reduction following treatment (p < 0.001). The simplified guided approach demonstrated favorable translational feasibility and practical clinical integration under routine treatment conditions. Conclusions: Within the limitations of this prospective translational clinical proof-of-concept study, the proposed simplified guided single-implant workflow demonstrated encouraging early clinical, radiographic, and patient-centered outcomes for mandibular overdenture rehabilitation. Further multicenter investigations involving larger patient cohorts, multiple operators, longer follow-up periods, and comparative study designs are required to evaluate long-term clinical performance, reproducibility, and comparative effectiveness relative to established treatment protocols.