一项评估两件式氧化锆和钛种植体上螺丝固位混合基台冠3年生存率和技术并发症的随机对照试验。
A Randomised Controlled Trial Evaluating 3-Year Survival Rates and Technical Complications of Screw-Retained Hybrid Abutment Crowns on Two-Piece Zirconia and Titanium Implants.
作者信息
Sterzenbach Guido, Richter Kristin, Alpen Klara, Khoshreza Hediyeh, Beuer Florian, Thiele Theodor
机构信息
Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Berlin, Germany.
MVZ Zahnmedizin Pankow, Dentalzentrum Pankow, Berlin, Germany.
出版信息
Clin Oral Implants Res. 2025 Aug;36(8):965-977. doi: 10.1111/clr.14443. Epub 2025 Apr 29.
OBJECTIVES
This study compares the cumulative survival and technical complications of screw-retained implant-supported lithium disilicate crowns (SICs) on polyether ketone ketone (PEKK) base abutments and zirconia implants with those of titanium base abutments and titanium implants.
MATERIALS AND METHODS
Sixty participants were randomly and evenly assigned to receive zirconia or titanium implants. Survival and technical complications were assessed at 6 weeks after crown placement (baseline) up to 36 months. The cumulative survival of the SICs was analysed as a non-inferiority design, assuming that the difference between the titanium group and the zirconia group is not more than 10%. Technical complications were assessed based on modified USPHS criteria and Pink Aesthetic Score (PES).
RESULTS
In the zirconia group, three early implant failures occurred; all of them were successfully revised. After baseline, three implants in the zirconia group were lost due to insufficient osseointegration, and therefore the SICs have to be categorised as failures even though none of the SICs failed. The non-inferiority of the zirconia group could not be confirmed, as the cumulative survival was 10.7% lower compared to the titanium group (100%). The technical complication rate was low, with no statistically significant difference between the groups. The PESs improved significantly compared to baseline, with no significant difference between the groups at 12 months.
CONCLUSION
Hybrid abutment SICs with PEKK base abutments on two-piece zirconia implants could be an alternative to hybrid abutments SICs with titanium base on titanium implants. However, the lower osseointegration rate of the zirconia implants has to be considered.
TRIAL REGISTRATION
This study was registered in the German Clinical Trial Register (Deutsches Register Klinischer Studien) (number: DRKS00014866).
目的
本研究比较了聚醚酮酮（PEKK）基台和氧化锆种植体上的螺丝固位种植体支持的二硅酸锂全冠（SICs）与钛基台和钛种植体的累积生存率及技术并发症。
材料与方法
60名参与者被随机且平均分配接受氧化锆或钛种植体。在全冠就位后6周（基线）直至36个月期间评估生存率和技术并发症。SICs的累积生存率采用非劣效性设计进行分析，假设钛组和氧化锆组之间的差异不超过10%。基于改良的美国公共卫生服务（USPHS）标准和粉色美学评分（PES）评估技术并发症。
结果
在氧化锆组，发生了3例早期种植体失败；均成功进行了修复。基线后，氧化锆组有3枚种植体因骨结合不足而丢失，因此尽管没有SICs失败，但这些SICs仍被归类为失败。由于与钛组（100%）相比，氧化锆组的累积生存率低10.7%，故无法确认氧化锆组的非劣效性。技术并发症发生率较低，两组之间无统计学显著差异。与基线相比，PES显著改善，12个月时两组之间无显著差异。
结论
两件式氧化锆种植体上带有PEKK基台的混合基台SICs可能是钛种植体上带有钛基台的混合基台SICs的一种替代方案。然而，必须考虑氧化锆种植体较低骨结合率的问题。
试验注册
本研究已在德国临床试验注册中心（Deutsches Register Klinischer Studien）注册（编号：DRKS00014866）。
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