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Clinical outcomes of a novel one-piece niobia-modified zirconia implant compared with a titanium implant at 48 weeks: a multicenter randomized controlled trial

Year: 2026

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: PURPOSE: To compare the clinical outcomes of one-piece niobia-modified yttria-stabilized tetragonal zirconia polycrystal ((Y,Nb)-TZP) implants with those of clinically established titanium implants during the first 48 weeks post-placement. MATERIALS AND METHODS: This multi-center, randomized controlled clinical trial evaluated patients requiring a single premolar or molar implant. Participants underwent random assignment to receive either an experimental one-piece (Y,Nb)-TZP implant or a control two-piece transmucosal titanium implant. The protocol comprised seven visits over a one-year observation period. Following 10 weeks of healing, abutment-level definitive impressions were obtained, and monolithic zirconia crowns were delivered at 16 weeks. The primary outcome was the implant success rate at the end of the follow-up period (48 weeks). Secondary outcomes included marginal bone level (MBL) changes, implant survival, esthetic scores, and peri-implant soft tissue status. To evaluate non-inferiority, a one-sided statistical test was performed at a significance level of 0.025. For all other comparative analyses, two-sided tests were applied with a significance threshold of 0.05. RESULTS: = .0408); however, both differences were only marginally significant and were not adjusted for multiple secondary comparisons. The prespecified non-inferiority criterion for implant success rate was numerically met (upper limit of the one-sided 97.5% confidence interval for the between-group difference, 0.00%; margin, 10.0 percentage points), although this interval was degenerate given the absence of implant failures in either group. CONCLUSION: One-piece (Y,Nb)-TZP implants showed favorable short-term clinical performance and safety comparable to established two-piece transmucosal titanium implants over one year, and the prespecified non-inferiority criterion for implant success rate was numerically met; however, this criterion was assessed under a boundary condition (100% success in both groups) that limits its precision. Larger studies with longer follow-up are warranted to confirm non-inferiority and long-term effectiveness.

Source: The Journal of Advanced Prosthodontics

DOI: 10.4047/jap.2026.18.5.508