Jung Ronald E, Grohmann Philipp, Sailer Irena, Steinhart Yann-Niclas, Fehér Aurel, Hämmerle Christoph, Strub Jörg Rudolf, Kohal Ralf
Clinic of Fixed and Removable Prosthodontics and Dental Material Science, Center of Dental Medicine, University of Zurich, Zurich, Switzerland.
Division of Fixed Prosthodontics and Biomaterials, Clinic of Dental Medicine, University of Geneva, Geneva, Switzerland.
Clin Oral Implants Res. 2016 Jul;27(7):751-61. doi: 10.1111/clr.12670. Epub 2015 Jul 27.
The aim of this clinical trial was to evaluate the safety and efficiency of a one-piece zirconia oral implant after 1 year of function.
Two centers included 60 subjects in need of implant-supported single-tooth restorations or three-unit bridges. A total of 71 zirconia one-piece implants were placed and immediately restored with a temporary reconstruction for at least 2 months. The final veneered zirconia restorations were then cemented and followed for 6 months and 1 year after insertion of the restorations. At each visit, a clinical evaluation was performed to analyze biological parameters of the implants and the neighboring teeth. A standardized periapical radiograph was taken at implant insertion, at the placement of the restorations and at the 1-year follow-up.
Sixty patients with 71 implants (48 in the mandible, 23 in the maxilla) were included in this study and provided with 11 bridges and 49 crowns. Two patients with three implants (one bridge and one single crown) could not be evaluated. One patient lost his implant 5 weeks after implant insertion. Based on 58 patients, the mean survival rate was 98.3% after one year when the implants of the two patients that did not show up were not counted as lost. The mean marginal bone loss from implant insertion to the 1-year follow-up after the final prosthetic restoration was 0.78 mm with a standard deviation of 0.79 mm. The probing depth around the implants increased from 2.7 mm at insertion of the prosthetic reconstruction to 3.5 mm one year after insertion. The probing depth around the adjacent teeth remained stable at 2.5 mm. At the 1-year recall, the difference was significant. The clinical attachment levels at implants and teeth were not different at the 1-year follow-up with 3.1 mm at tooth and implant sites.
The presently tested one-piece ceramic implant was successful in replacing single tooth and three-unit gaps after one year of function. Further long-term data are necessary to verify these initial findings.
本临床试验的目的是评估一体式氧化锆口腔种植体在功能使用1年后的安全性和有效性。
两个中心纳入了60名需要种植体支持的单颗牙修复或三单位桥修复的受试者。共植入71颗一体式氧化锆种植体，并立即进行临时修复，至少持续2个月。然后进行最终的烤瓷氧化锆修复体粘结，并在修复体植入后随访6个月和1年。每次随访时，进行临床评估以分析种植体和相邻牙齿的生物学参数。在种植体植入时、修复体放置时以及1年随访时拍摄标准化根尖片。
本研究纳入了60例患者的71颗种植体（下颌48颗，上颌23颗），并制作了11个桥体和49个冠。两名植入三颗种植体（一个桥体和一个单冠）的患者无法进行评估。一名患者在种植体植入后5周丢失了种植体。基于58名患者，若不将未前来复诊的两名患者的种植体算作丢失，则一年后的平均存留率为98.3%。从种植体植入到最终修复后1年随访，平均边缘骨吸收为0.78mm，标准差为0.79mm。种植体周围的探诊深度从修复体植入时的2.7mm增加到植入后1年的3.5mm。相邻牙齿周围的探诊深度保持在2.5mm稳定不变。在1年复查时，差异具有统计学意义。在1年随访时，种植体和牙齿部位的临床附着水平无差异，均为3.1mm。
目前测试的一体式陶瓷种植体在功能使用1年后成功替代了单颗牙和三单位间隙。需要进一步的长期数据来验证这些初步结果。
