Evaluating Personalized Additive-Manufactured Titanium Mesh Versus Traditional Titanium Mesh for Guided Bone Regeneration in Large Alveolar Bone Defects

What this Trial Is About

Researchers are evaluating the effects of additive-manufactured personalized titanium mesh compared to traditional prefabricated titanium mesh in guided bone regeneration for patients with large alveolar bone defects. This randomized, single-blind, positive-controlled prospective study aims to assess both short-term and long-term outcomes, including safety and complications, with a follow-up period of two years after surgery. Participants will undergo guided bone regeneration surgery using either additive-manufactured personalized titanium mesh designed from preoperative CBCT data or prefabricated titanium mesh. Both types of mesh are used to secure bone substitutes with fixation screws during the bone grafting procedure. The study includes a positive control group receiving the prefabricated mesh for comparison. During the study, participants will receive clinical and radiographic examinations free of charge at multiple time points over two years. Researchers will measure osteogenesis efficiency at 6 months and monitor the incidence of titanium mesh exposure at intervals up to 2 years post-surgery. The study also involves analysis of risk factors related to the treatments and overall participant safety monitoring throughout the follow-up period.

Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration