Friberg Bertil, Raghoebar Gerry M, Grunert Ingrid, Hobkirk John A, Tepper Gabor
Clinic of Odontology, Brånemark Clinic, Public Dental Health, Göteborg, Sweden.
Int J Oral Maxillofac Implants. 2008 May-Jun;23(3):481-6.
The purpose of the current prospective multicenter study was to evaluate the 5-year implant success and peri-implant conditions of smooth-surface Brånemark System implants when using a novel technique including a 1-stage surgical procedure with early loading in edentulous mandibles.
The study protocol included 1-stage surgery as well as placement of the definitive prosthesis within 6 weeks after implant insertion (ie, early loading). Clinical evaluation, as well as evaluation of function and esthetics, was performed at each follow-up visit. Radiographs were obtained at connection of the prostheses and at the 1, 3-, and 5-year check-ups.
A total of 40 patients with a mean age of 56 years (range, 30 to 70) were included in the study. In all, 170 implants were placed in between the mental foramina, of which 120 implants in 30 patients were associated with overdenture treatment and 50 implants in 10 patients with fixed complete dentures. Twelve implants failed in 6 patients. The cumulative implant survival rate was 92.9% after both 1 and 5 years of follow-up. Another 3 implants were recorded as mobile but still in function when individually checked at the 5-year visit, which resulted in a cumulative success rate of 91.0%. Mean bone remodeling over the study period was less than 0.1 mm/y after the first year of loading, resulting in a mean marginal bone level of 0.66 mm (SD 0.73, n = 138) apical to the implant collar reference point after 5 years.
One-stage, early loaded smooth-surface Brånemark System implants functioned well for the majority of patients with edentulous mandibles. Stable peri-implant conditions were observed. Bone remodeling resulted in a mean bone level above the first implant thread after 5 years. The somewhat lower success rate of 91.0% compared to a 2-stage procedure may be related to generous inclusion criteria and to a learning curve involving a novel treatment procedure.
本前瞻性多中心研究旨在评估在无牙下颌骨中使用一种新技术（包括一期手术程序和早期负重）时，表面光滑的Brånemark种植系统种植体的5年种植成功率及种植体周围状况。
研究方案包括一期手术以及在种植体植入后6周内（即早期负重）安装最终修复体。每次随访时进行临床评估以及功能和美观评估。在修复体连接时以及1年、3年和5年检查时拍摄X光片。
共有40名平均年龄为56岁（范围30至70岁）的患者纳入研究。总共在颏孔之间植入了170颗种植体，其中30名患者的120颗种植体用于覆盖义齿治疗，10名患者的50颗种植体用于固定全口义齿。6名患者中有12颗种植体失败。随访1年和5年后，种植体累积留存率为92.9%。在5年随访单独检查时，另有3颗种植体记录为松动但仍在发挥功能，累积成功率为91.0%。在负重第一年之后的研究期间，平均骨改建每年小于0.1毫米，5年后种植体颈部参考点根尖处的平均边缘骨水平为0.66毫米（标准差0.73，n = 138）。
对于大多数无牙下颌骨患者，一期早期负重的表面光滑的Brånemark种植系统种植体功能良好。观察到种植体周围状况稳定。骨改建导致5年后平均骨水平高于第一根种植体螺纹。与二期手术相比，成功率略低的91.0%可能与宽松的纳入标准以及涉及新治疗程序的学习曲线有关。
