Nobel Direct种植体的短期临床效果：一项回顾性多中心分析
Short-term clinical results of Nobel Direct implants: a retrospective multicentre analysis.
作者信息
Sennerby Lars, Rocci Antonio, Becker William, Jonsson Lars, Johansson Lars-Ake, Albrektsson Tomas
机构信息
Department of Biomaterials, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.
出版信息
Clin Oral Implants Res. 2008 Mar;19(3):219-26. doi: 10.1111/j.1600-0501.2007.01410.x.
PURPOSE
The present retrospective clinical study was undertaken to evaluate the survival rate and marginal bone conditions around Nobel Direct one-piece implants. The purpose was also to compare the results with when these implants are used for immediate/early loading with implants allowed to heal before loading.
MATERIAL AND METHODS
Forty-three consecutive patients previously treated with 117 Nobel Direct implants at four different centres were evaluated. The implants had been used in both jaws for treatment after loss of single and multiple teeth. Immediate/early loading (within 2 weeks) with a provisional crown/bridge was applied to 95 implants, while 22 implants healed unloaded for 6 weeks to 6 months before loading. Calculations of marginal bone loss were performed in radiographs taken at placement and after an average of 10.2 months (range 1-18 months) of loading.
RESULTS
Six (5.1%) of the 117 implants were removed during the follow up. All failed implants belonged to the immediate/early loading group giving a failure rate of 6.3% for this group and 0% for two-stage implants. The failure rate was higher for flapless (7.9%) than for flap surgery (0%). The marginal bone loss was -2.4 mm (SD 1.5) for all implants, while 37.6% showed more than 3 mm of loss during the follow up. Bone loss increased with time of follow up. Implants subjected to immediate/early loading showed more bone loss than two-stage implants: -2.6 mm (SD 1.5) vs. -1.6 mm (SD 1.1). Moreover, 41.3% of immediately loaded and 22.7% of two-stage implants presented with more than 3 mm of bone loss.
CONCLUSIONS
This short-term retrospective analysis showed a poor clinical outcome of Nobel Direct implants. Extensive marginal bone loss (>3 mm) was found around more than 1/3 of the implants evaluated. Less resorption and no failures were experienced when implants were allowed to heal from 6 weeks to 6 months before occlusal loading. Within the limitations of the present study design, data indicate that immediate loading, the use of this implant for multi-unit constructions and flapless surgery are risk factors for failure of Nobel Direct implants.
目的
开展本次回顾性临床研究，以评估Nobel Direct一体式种植体的存活率及边缘骨情况。研究目的还包括将这些种植体即刻/早期负重与负重前先愈合的种植体的使用结果进行比较。
材料与方法
对在四个不同中心接受过117颗Nobel Direct种植体治疗的43例连续患者进行评估。这些种植体用于上下颌单颗及多颗牙齿缺失后的治疗。95颗种植体采用即刻/早期负重（2周内）并安装临时冠/桥，而22颗种植体在负重前无负载愈合6周至6个月。在种植体植入时及平均负重10.2个月（范围1 - 18个月）后拍摄的X光片中进行边缘骨丢失量的计算。
结果
117颗种植体中有6颗（5.1%）在随访期间被取出。所有失败的种植体均属于即刻/早期负重组，该组失败率为6.3%，二期种植体失败率为0%。无瓣手术组（7.9%）的失败率高于翻瓣手术组（0%）。所有种植体的边缘骨丢失量为 -2.4 mm（标准差1.5），而37.6%的种植体在随访期间边缘骨丢失超过3 mm。骨丢失量随随访时间增加。即刻/早期负重的种植体比二期种植体的骨丢失更多：-2.6 mm（标准差1.5）对 -1.6 mm（标准差1.1）。此外，即刻负重种植体中有41.3%、二期种植体中有22.7%的边缘骨丢失超过3 mm。
结论
这项短期回顾性分析显示Nobel Direct种植体的临床结果不佳。在超过1/3的评估种植体周围发现了广泛的边缘骨丢失（>3 mm）。种植体在咬合负重前6周至6个月愈合时，骨吸收较少且无失败情况。在本研究设计的局限性内，数据表明即刻负重、将此种植体用于多单位结构以及无瓣手术是Nobel Direct种植体失败的风险因素。
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