Clinical outcomes of a novel one-piece niobia-modified zirconia implant compared with a titanium implant at 48 weeks: a multicenter randomized controlled trial.
5 affiliations
- 1Department of Periodontology, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Republic of Korea.
- 2Department of Periodontology, School of Dentistry and Dental Research Institute, Seoul National University, Seoul, Republic of Korea.
- 3Division of Oral and Maxillofacial Surgery, Department of Dentistry, College of Medicine, Hanyang University, Seoul, Republic of Korea.
- 4Department of Prosthodontics, School of Dentistry and Dental Research Institute, Seoul National University, Seoul, Republic of Korea.
- 5Dental Research Institute, Seoul National University, Seoul, Republic of Korea.
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
Forty-eight patients completed the trial and were included in the final analysis. At 48 weeks, all implants in both groups met the success criteria, yielding 100% survival. There were no statistically significant differences between the cohorts in terms of MBL changes or white esthetic scores. At 48 weeks, the pink esthetic score was higher in the control group (8.17 ± 2.22 vs. 7.25 ± 1.98; P = .0489), whereas the modified sulcus bleeding index was lower in the test group, with no sulcus bleeding recorded around any (Y,Nb)-TZP implant (0.00 ± 0.00 vs. 0.17 ± 0.38; P = .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.
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BibTeX
@article{kim2026clinical,
title = {{Clinical outcomes of a novel one-piece niobia-modified zirconia implant compared with a titanium implant at 48 weeks: a multicenter randomized controlled trial.}},
author = {Yee Hyun Kim and Yeonsoo Seo and Kyoung-Hwa Kim and Young-Sung Kim and Chang-Joo Park and Jun-Ho Cho and Dae-Joon Kim and Yang-Jo Seol and In-Sung Luke Yeo},
journal = {The journal of advanced prosthodontics},
year = {2026},
month = oct,
doi = {10.4047/jap.2026.18.5.508},
url = {https://europepmc.org/article/MED/42948547},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Clinical outcomes of a novel one-piece niobia-modified zirconia implant compared with a titanium implant at 48 weeks: a multicenter randomized controlled trial.
AU - Yee Hyun Kim
AU - Yeonsoo Seo
AU - Kyoung-Hwa Kim
AU - Young-Sung Kim
AU - Chang-Joo Park
AU - Jun-Ho Cho
AU - Dae-Joon Kim
AU - Yang-Jo Seol
AU - In-Sung Luke Yeo
PY - 2026
DA - 2026/10/13
JO - The journal of advanced prosthodontics
DO - 10.4047/jap.2026.18.5.508
UR - https://europepmc.org/article/MED/42948547
AB - 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 Forty-eight patients completed the trial and were included in the final analysis. At 48 weeks, all implants in both groups met the success criteria, yielding 100% survival. There were no statistically significant differences between the cohorts in terms of MBL changes or white esthetic scores. At 48 weeks, the pink esthetic score was higher in the control group (8.17 ± 2.22 vs. 7.25 ± 1.98; P = .0489), whereas the modified sulcus bleeding index was lower in the test group, with no sulcus bleeding recorded around any (Y,Nb)-TZP implant (0.00 ± 0.00 vs. 0.17 ± 0.38; P = .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.
SN - 2005-7806
SN - 2005-7814
ER -