Bernhard Gottlieb University Clinic of Dentistry, Sensengasse 2a, 1090, Vienna, Austria.
University of Rome Tor Vergata, Rome, Italy.
Clin Oral Investig. 2017 Jul;21(6):2133-2142. doi: 10.1007/s00784-016-2003-0. Epub 2016 Nov 18.
The aim of this multicenter prospective clinical study was to evaluate anodized tapered implants with a conical connection and integrated platform shifting placed in the anterior and premolar maxilla.
The study enrolled patients requiring single-tooth restorations in healed sites of maxillary anterior and premolar teeth. All implants were immediately temporized. Clinical and radiographic evaluations were conducted at implant insertion, 6 months, and 1 year. Outcome measures included bone remodeling, cumulative survival rate (CSR), success rate, soft-tissue health and esthetics, and patient satisfaction. Bone remodeling and pink esthetic score were analyzed using Wilcoxon signed-rank tests. CSR was calculated using life table analysis. Other soft-tissue outcomes were analyzed using sign tests.
Out of 97 enrolled patients (102 implants), 87 patients (91 implants) completed the 1-year visit. Marginal bone remodeling was -0.85 ± 1.36 mm. After the expected initial bone loss, a mean bone gain of 0.11 ± 1.05 mm was observed between 6 months and 1 year. The CSR was 99.0%, and the cumulative success rate was 97.0%. Partial or full papilla was observed at 30.8% of sites at baseline, 87.2% at 6 months, and 90.5% at 1 year. Soft-tissue response, esthetics, and patient satisfaction all improved during the study period.
Bone gain was observed following the expected initial bone loss, and soft-tissue outcomes improved suggesting favorable tissue response using anodized tapered conical connection implants.
Rapid stabilization of bone remodeling and robust papilla regeneration indicate favorable tissue healing promoted by the conical connection, platform-shift design.
clinicaltrials.gov NCT02175550.
本多中心前瞻性临床研究旨在评估具有锥形连接和整合平台转移的阳极氧化锥形种植体在前牙和前磨牙上颌骨中的应用。
本研究纳入了需要在前牙和前磨牙愈合部位进行单颗牙修复的患者。所有种植体均立即进行临时修复。在种植体植入、6 个月和 1 年时进行临床和影像学评估。评估指标包括骨重塑、累积存活率（CSR）、成功率、软组织健康和美观以及患者满意度。采用 Wilcoxon 符号秩检验分析骨重塑和粉红色美学评分。采用寿命表分析计算 CSR。采用符号检验分析其他软组织结局。
97 名患者（102 个种植体）中，87 名患者（91 个种植体）完成了 1 年随访。边缘骨重塑为-0.85±1.36mm。在预期的初始骨丢失后，6 个月至 1 年期间观察到平均 0.11±1.05mm 的骨获得。CSR 为 99.0%，累积成功率为 97.0%。基线时 30.8%的位点存在部分或完全的龈乳头，6 个月时为 87.2%，1 年时为 90.5%。在研究期间，软组织反应、美观和患者满意度均有所改善。
在预期的初始骨丢失后观察到骨获得，软组织结局改善，表明阳极氧化锥形连接种植体具有有利的组织反应。
快速稳定的骨重塑和强健的龈乳头再生表明锥形连接、平台转移设计促进了有利的组织愈合。
clinicaltrials.gov NCT02175550。
