歯科インプラント用途におけるβ型Ti-Nb-Zr合金の構造-特性-機能評価と短期臨床的検証

Titanium-based alloys are widely used in dental implantology; however, the mechanical limitations of commercially pure titanium (cpTi) and unresolved concerns regarding stress shielding remain. This study evaluated the structure-property-function relationship of a novel β-type titanium-niobium-zirconium (Ti-Nb-Zr; TNZ) alloy for dental implant applications. Laboratory testing assessed the elemental composition, tensile properties, and fatigue resistance of the cpTi, compared with modified Grade 4 cpTi (MG4T). In parallel, a randomized, single-blind, controlled clinical trial was conducted over 12 months to compare the clinical performance of TNZ and MG4T implants under functional loading. A total of 80 participants (mean age: 54.2 years; 43 females, 37 males) were enrolled, with 77 completing the 12-month follow-up (TNZ: n = 38; MG4T: n = 39). Clinical outcomes included implant success and survival, peri-implant soft tissue parameters, marginal bone levels, fractal dimension (FD) analysis of trabecular bone, and adverse events. TNZ implants demonstrated superior fatigue resistance without an increase in the elastic modulus relative to MG4T. Clinically, both groups achieved 100% implant success and survival, with no implant-related adverse events. FD analysis revealed time-dependent bone remodeling without evidence of pathological adaptation. These findings support the functional viability of TNZ as a mechanically robust, biocompatible implant material. Further long-term, multicenter trials are warranted to confirm sustained clinical benefits and broader applicability.