The use of reduced healing times on ITI® implants with a sandblasted and acid-etched (SLA) surface:: Early results from clinical trials on ITI® SLA implants
The use of reduced healing times on ITI® implants with a sandblasted and acid-etched (SLA) surface:: Early results from clinical trials on ITI® SLA implants
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DOI：
10.1034/j.1600-0501.2002.130204.x
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发表时间：
2002-04-01
影响因子：
4.3
通讯作者：
Simpson, JP
中科院分区：
文献类型：
--
作者：
Cochran, DL;Buser, D;Simpson, JP
ITI(R)牙种植体有两种骨锚定表面，一种是钛等离子喷涂（TPS）表面，另一种是最近推出的喷砂酸蚀（SLA）表面。细胞培养和动物试验表明，SLA表面刺激骨细胞分化和蛋白质产生，具有大量的骨与种植体接触，并在骨接触的功能测试中产生大的去除扭矩值。作为这些研究的结果，一项前瞻性的人体临床试验被启动，以确定4.1 prim直径SLA ITI(R)实体螺钉植入物是否可以在植入手术后6周预测和安全地恢复。该方案将缩短愈合时间的使用限制在a)有足够骨体积包围种植体的健康患者，以及b)在种植体受体部位具有良好骨质量（I-III级）的患者。骨质量较差的患者（IV级）直到种植体放置后12周才进行修复。该临床试验是一项正在进行的多中心试验，在四个国家设有六个中心，随访时间超过五年。主要结果变量为35 Ncm力的基台放置，无反扭，无种植体疼痛或旋转。次要结果是种植体成功，定义为无活动，无持续疼痛或感染，无种植体周围透光度。到目前为止，有110名患者（326个种植体）完成了一年的装载后召回访问，而47名患者（138个种植体）完成了两年的召回。三个种植体在连接基台之前丢失。307个假体在缩短愈合时间后开始修复。这些种植体的成功率，根据基台放置判断，为99.3%（平均愈合时间为49天）。生命表分析显示，种植体的成功率为99.1%，一年329个种植体和两年138个种植体。在修复后的24个月期间，138个种植体未报告种植体损失。这些结果表明，在规定的条件下，具有SLA内表面的实心螺钉ITI(R)种植体可以在大约六周的愈合后恢复，并且具有很高的可预测性，通过在35 Ncm处放置基台而无反扭力来定义，并且修复后两年内的种植成功率大于99%。
ITI(R) dental implants are available with two bone-anchoring surfaces, a titanium plasma-sprayed (TPS) surface, and a recently introduced sandblasted and acid-etched (SLA) surface, Cell culture and animal tests demonstrate that the SLA surface stimulates bone cell differentiation and protein production, has large amounts of bone-to-implant contact and results in large removal torque values in functional testing of the bone contact. As a result of these studies, a prospective human clinical trial was initiated to determine whether the 4.1 prim diameter SLA ITI(R) solid screw implants could be predictably and safely restored as early as six weeks after implant placement surgery. The protocol restricted the use of the reduced healing time to a) healthy patients with sufficient bone volume to surround the implant, and b) those patients who had good bone quality (classes I-III) at the implant recipient site. Patients with poorer bone quality (class IV) did not have restorations until 12 weeks after implant placement. The clinical trial is an ongoing multicenter trial, with six centers in four countries, and with follow-up over five years. The primary outcome variable was abutment placement with a 35 Ncm force, with no countertorque and no pain or rotation of the implant. A secondary outcome was implant success, as defined by no mobility, no persistent pain or infection, and no peri-implant radiolucency. To date, 110 patients with 326 implants have completed the one-year postloading recall visit, while 47 patients with 138 implants have completed the two-year recall. Three implants were lost prior to abutment connection. Prosthetic restoration was commenced after shortened healing times on 307 implants. The success rate for these implants, as judged by abutment placement, was 99.3% (with an average healing time of 49 days). Life table analyses demonstrated an implant success rate of 99.1%, both for 329 implants at one year and for 138 implants at two years. In the 24-month period after restoration, no implant losses were reported for the 138 implants. These results demonstrate that, under defined conditions, solid screw ITI(R) implants with an SLA endosseous surface can be restored after approximately six weeks of healing with a high predictability of success, defined by abutment placement at 35 Ncm without countertorque, and with subsequent implant success rates of greater than 99% two years after restoration.