Clinical performance of a newly developed two-piece zirconia implant system in the maxilla: A prospective multicentre study.

Jonas Lorenz, Puria Parvini, Karina Obreja, Georgia Trimpou, Susy Linder, Werner Hölscher, Michel Dard, Frank Schwarz, Robert Sader
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Abstract

Purpose: To assess the clinical performance of a two-piece zirconia implant system (PURE Ceramic Implants, Straumann, Basel, Switzerland) in the maxilla after a follow-up period of more than 1 year.

Materials and methods: A total of 19 patients in three centres received 24 single-tooth implants in the maxilla. The implants were restored after a mean healing period of 7.1 ± 0.4 months (range 7 to 9 months). Implant survival, implant success, Plaque Index, probing pocket depth, bleeding on probing, mucosal recession/creeping attachment, width of keratinised mucosa, papilla index and pink aesthetic score were evaluated after prosthetic loading (T0), after 6 months (T1) and at the final follow-up (T2, mean 15.0 ± 2.1 months, range 12 to 19 months).

Results: All implants survived and were suitable for retaining prostheses. Low values were recorded for Plaque Index (0.38 ± 0.68) and probing pocket depth (2.49 ± 0.49 mm). Bleeding on probing increased significantly from T0 (21.7%) to T1 (50.0%) (P = 0.0342) and then remained stable (50.0% at T2). No recession was detected around any of the implants. A statistically significant increase in attachment level was observed from T0 to T2 (0.79 ± 0.88 mm; P = 0.0196). A papilla index of 2.27 ± 0.81 and pink aesthetic score of 11.67 ± 1.60 at T2 indicated a completely satisfying aesthetic result.

Conclusion: Within the limitations of the present study, the two-piece zirconia implant system investigated achieved fully satisfying functional and aesthetic results.

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新开发的上颌骨两片式氧化锆种植系统的临床性能:一项前瞻性多中心研究。
目的:对两片式氧化锆种植体(PURE Ceramic implant, Straumann, Basel, Switzerland)在上颌的临床应用进行1年多的随访。材料与方法:3个中心共19例患者在上颌植入24颗单牙种植体。种植体平均愈合时间为7.1±0.4个月(7 ~ 9个月)。在假体加载后(T0)、6个月后(T1)和最终随访时(T2,平均15.0±2.1个月,范围12至19个月)评估种植体存活、种植体成功、斑块指数、探诊袋深度、探诊时出血、粘膜退缩/蠕动附着、角化粘膜宽度、乳头指数和粉红色美学评分。结果:所有种植体均成活,适合固定假体。牙菌斑指数(0.38±0.68)和探测袋深度(2.49±0.49 mm)较低。探查出血从T0(21.7%)到T1(50.0%)显著增加(P = 0.0342), T2时保持稳定(50.0%)。在任何植入物周围都没有检测到衰退。从T0到T2,附着水平显著增加(0.79±0.88 mm;P = 0.0196)。T2时乳头指数为2.27±0.81,粉红色美学评分为11.67±1.60,美学效果完全满意。结论:在本研究的限制下,所研究的两片式氧化锆种植体系统获得了令人满意的功能和美观效果。
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