RANDOMIZED CONTROLLED TRIAL COMPARING A VARIABLE-THREAD NOVEL TAPERED AND A STANDARD TAPERED IMPLANT: INTERIM ONE-YEAR RESULTS
RANDOMIZED CONTROLLED TRIAL COMPARING A VARIABLE-THREAD NOVEL TAPERED AND A STANDARD TAPERED IMPLANT: INTERIM ONE-YEAR RESULTS
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DOI：
10.1016/s0022-3913(09)60060-3
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发表时间：
2009-05-01
影响因子：
4.6
通讯作者：
Sanz, Mariano
中科院分区：
文献类型：
--
作者：
Kielbassa, Andrej M.;Martinez-de Fuentes, Rafael;Sanz, Mariano
问题陈述。一种锥形植入物已经被开发出来，该植入物具有连续变化的螺纹，据称可以提供稳定的组织支持并允许即时功能。治疗的成功和随着时间的推移支持组织的稳定需要记录。这项前瞻性、随机、对照、多中心研究的目的是评价新型种植体(NobelActive/NA)和标准锥形种植体(NobelReasedGroovy/NR)在即刻功能方面的骨水平和软组织行为的变化。材料和方法。177例患者随机分为3个处理组(2个不同的种植体测试组：NA内部(n=117；内部连接)和外部(n=82)，1个标准治疗组(n=126))，共植入325颗种植体。种植体被放置到愈合的部位，除了6个种植体外，所有的种植体都立即非咬合加载。在植入时、3、6和12个月后进行临床和放射学评估，评估治疗成功率、顶骨水平和软组织变化。存活率差异分析采用Log-Rank检验。用Kruskal-Wallis检验和Mann-Whitney U检验比较边缘骨水平(α=0.05)。一年累积生存率相似(NA内置组为96.6%；NA外置组为96.3%；NR组为97.6%；P=.852；Log-Rank)。骨平面的平均变化(SD)：NA内侧为-0.95 mm(1.37)，NA外侧为-0.64 mm(0.97)，NR为-0.63 mm(1.18)(P=.589；Kruskal-Wallis)。软组织稳定，乳头评分明显增加(P
Statement of problem. A tapered implant with continuously changing threads purported to provide stable tissue support and allow immediate function has been developed. Treatment success and stabilization of supporting tissues over time require documentation.Purpose. The purpose of this prospective, randomized, controlled, multicenter study was to evaluate changes in bone level and soft tissue behavior between the novel implant (NobelActive/NA) and a standard tapered implant (NobelReplace Tapered Groovy/NR) with regard to immediate function.Material and methods. A total of 177 patients randomly allocated to 3 treatment groups (2 different test implant groups: NA Internal (n=117; internal connection) and External (n=82), and 1 standard treatment group, NR (n=126)) received 325 implants. Implants were placed into healed sites, and all but 6 Implants were immediately nonocclusally loaded. Clinical and radiographic evaluations of treatment success, crestal bone levels, and soft tissue changes were performed at the time of placement and after 3, 6, and 12 months. Log-Rank test was used to analyze the differences in survival rate. Marginal bone level was compared using the Kruskal-Wallis test and Mann-Whitney U-test (alpha=.05).Results. One-year cumulative survival rates were comparable (96.6% for NA Internal; 96.3% for NA External; 97.6% for NR; P=.852; Log-Rank). Mean (SD) change in bone level was -0.95 mm (1.37) for NA Internal, -0.64 mm (0.97) for NA External, and -0.63 mm (1.18) for NR (P=.589; Kruskal-Wallis). Stable soft tissues and significantly increased papilla scores (P