Tristan Staas^1,*; Istvan Urban²; Giacomo Fabbri³

¹Staas & Bergmans, ’s-Hertogenbosch, Netherlands; ²Urban Dental Center Kft, Budapest, Hungary; ³Studio Odontoiatrico Specialistico Ban Mancini Fabbri, Cattolica, Italy

Background: Successful osseointegration is influenced by implant characteristics such as geometry and surface, as well as implant site preparation technique. The novel N1 concept system introduces OsseoShapers, novel site preparation instruments that operate at low speeds of 50rpm and with no irrigation, and a trioval tapered N1 implant designed to reduce stress on cortical bone without sacrificing mechanical stability. Its surface is gradually anodized for optimized tissue integration at every level.

Aim/Hypothesis: This multicenter retrospective investigation aims to evaluate the clinical performance of the Nobel Biocare N1 system concept after 1 year of function. The primary endpoint is to assess the marginal bone level change from loading to 12 months thereafter based on matched readable radiographs.

Material and Methods: This study included patients who are 18 years old or older and received at least one Nobel Biocare N1 concept system implant in one of the three participating clinics. Both fresh extraction sites as well as healing and healed sites in all indications were included. The primary endpoint is to evaluate the marginal bone level change of this novel implant concept system from loading to 12 months post loading while the secondary endpoints include implant survival and success rates as well as soft tissue healing parameters (plaque, bleeding, and gingival indices) at 12-months after loading.

Results: Of the included 165 implants (95 patients), 50 were loaded immediately, 41 early (48 hours to 3 months post-placement), 14 within 3 to 6 months, and 14 later than 6 months. Most implants (60.7%) were placed in healed sites. The indication included single tooth restorations (78 implants), partial (43 implants) and full edentulism (44 implants). The bone quality at the recipient sites was rated as very dense (14 sites), dense (16 sites), soft (88 sites) and very soft (38 sites). Over 90% of implants were placed after the OsseoShaper 1. The 12-month follow-up data were available for 145 implants, with the missing visits mostly due COVID-19 related delays with prosthetic visit. Of the 165 implants 4 failed, yielding the 1-year survival rate of 97.3%. Analyses including marginal bone levels, implant success, soft tissue health indices, as well as additional baseline characteristics of the patients, implant sites and surgical techniques, will be shown at the time of presentation.

Conclusion and Clinical implications: The novel Nobel Biocare N1 system concept offers an easy-to-use implant placement protocol, with most implants being placed after only two steps, and a very good survival rate across a wide variety of indications and treatment protocols.

Disclosure of Interest: T. Staas Conflict with: This study was supported by Nobel Biocare (grant T-193), I. Urban Conflict with: This study was supported by Nobel Biocare (grant T-193), G. Fabbri Conflict with: This study was supported by Nobel Biocare (grant T-193)

Keywords: clinical studies/trials, dental implants, implant survival

特里斯坦·斯塔斯^1,* ; 伊斯特万城市² ; 贾科莫·法布里³

¹ Staas & Bergmans，斯海尔托亨博斯，荷兰；² Urban Dental Centre Kft，布达佩斯，匈牙利；³ Studio Odontoiatrico Specialistico Ban Mancini Fabbri，意大利卡托利卡

背景：成功的骨整合受种植体特征（例如几何形状和表面）以及种植体位点准备技术的影响。新颖的 N1 概念系统引入了 OsseoShapers、以 50 rpm 的低速运行且无需冲洗的新型场地准备器械，以及设计用于在不牺牲机械稳定性的情况下减少皮质骨应力的三瓣锥形 N1 植入物。其表面逐渐阳极氧化，以优化各个层面的组织整合。

目的/假设：这项多中心回顾性调查旨在评估 Nobel Biocare N1 系统概念在使用 1 年后的临床性能。主要终点是根据匹配的可读射线照片评估从加载到 12 个月后边缘骨水平的变化。

材料和方法：本研究纳入了 18 岁或以上的患者，并且在三个参与诊所之一接受了至少一个 Nobel Biocare N1 概念系统植入物。包括所有适应症的新鲜拔牙部位以及愈合和愈合部位。主要终点是评估这种新型种植体概念系统从加载到加载后 12 个月的边缘骨水平变化，而次要终点包括种植体存活率和成功率以及软组织愈合参数（牙菌斑、出血和牙龈指数）装载后 12 个月。

结果：在包括的 165 个种植体（95 名患者）中，50 个立即加载，41 个早期加载（植入后 48 小时至 3 个月），14 个在 3 至 6 个月内加载，14 个在 6 个月后加载。大多数种植体 (60.7%) 被放置在愈合部位。适应症包括单牙修复（78 颗种植体）、部分（43 颗种植体）和全牙缺失（44 颗种植体）。受体部位的骨质量被评为非常致密（14 个部位）、致密（16 个部位）、柔软（88 个部位）和非常柔软（38 个部位）。超过 90% 的种植体是在 OsseoShaper 1 之后放置的。 12 个月的随访数据可用于 145 个种植体，缺失的就诊主要是由于 COVID-19 相关的假肢就诊延迟。在 165 颗种植体中，有 4 颗失败，1 年生存率为 97.3%。分析包括边缘骨水平、植入成功率、软组织健康指数、

结论和临床意义：新的 Nobel Biocare N1 系统概念提供了一种易于使用的种植体植入方案，大多数种植体只需两个步骤即可植入，并且在各种适应症和治疗方案中具有非常好的存活率。

利益披露：T. Staas 冲突：本研究得到 Nobel Biocare（授予 T-193）的支持，I. Urban Conflict 与：本研究得到 Nobel Biocare（授予 T-193）的支持，G. Fabbri 与：这项研究得到了 Nobel Biocare (grant T-193) 的支持

关键词：临床研究/试验，牙种植体，种植体存活率