Cochran David, Oates Thomas, Morton Dean, Jones Archie, Buser Daniel, Peters Francoise
Department of Periodontics, University of Texas Health Science Center at San Antonio, San Antonio, TX 78229-3900, USA.
J Periodontol. 2007 Jun;78(6):974-82. doi: 10.1902/jop.2007.060294.
Conventionally, endosseous dental implants have required 3 to 6 months of uninterrupted healing based on observations for dental implants that were characterized by a relatively smooth machined surface. Many studies have since demonstrated that implants with a roughened surface resulted in greater bone apposition, earlier bone contact, and a stronger bond between the implant and the bone, suggesting that implants with roughened surfaces could be loaded earlier than 3 to 6 months. Formal clinical studies confirmed that implants with rough surfaces can have abutments placed and be loaded occlusally as early as 6 weeks postplacement. The purpose of this prospective, human clinical investigation was to evaluate a large number of implants with a specific rough surface (sand-blasted acid-etched [SLA]) placed in everyday practice under routine private-practice conditions.
A prospective, multicenter, human clinical observational study was initiated with the goal of recruiting a minimum of 500 patients and 800 implants. The implants were to be placed and restored in predominantly private-practice settings around the world. Ninety-two practitioners in 16 countries agreed to participate, and 86 followed the study design. Patients had to be in good health, have sufficient bone to encase the implant, and agree to return for recall appointments. Exclusion criteria included heavy smoking (>10 cigarettes a day) and bone augmentation procedures at the implant site. All implants were two-piece (an abutment was to be placed after 6 weeks of healing) and were characterized by the presence of a transmucosal polished collar. Each implant had an SLA surface. All implants were positioned using a non-submerged (single-stage) surgical technique. Survival and success rates were calculated by life-table analyses.
A total of 706 patients were enrolled and 1,406 implants were placed. In the final analyses, 590 patients with 990 implants (70.4% of those enrolled) met all inclusion criteria, including placement of an abutment and provisional restoration within 63 days of surgical placement. The majority of implants were 10 and 12 mm long (78.7%) and were placed in type II and III bone (87%). Seventy-three percent of the implants were placed in the mandible, and 27% were placed in the maxilla. The cumulative survival rate was 99.56% at 3 years and 99.26% at 5 years. The overall success rate was 99.12% at 3 years and 97.38% after 5 years.
Under private-practice conditions, implants with an SLA surface could be placed and restored predictably within 6 to 8 weeks. Data from this prospective, multicenter, human observational study reinforced the results of more formal clinical studies and demonstrated that implants with the SLA surface can be restored in patients in approximately half of the time of conventional healing periods.
传统上，基于对具有相对光滑机加工表面的牙种植体的观察，骨内牙种植体需要3至6个月的不间断愈合期。此后许多研究表明，具有粗糙表面的种植体可导致更大的骨附着、更早的骨接触以及种植体与骨之间更强的结合，这表明具有粗糙表面的种植体可以在3至6个月之前进行加载。正式的临床研究证实，表面粗糙的种植体在植入后6周即可放置基台并进行咬合加载。这项前瞻性人体临床研究的目的是评估大量具有特定粗糙表面（喷砂酸蚀[SLA]）的种植体在日常私人执业条件下的情况。
启动了一项前瞻性、多中心人体临床观察研究，目标是招募至少500名患者和800颗种植体。这些种植体将主要在世界各地的私人执业环境中植入和修复。16个国家的92名从业者同意参与，86名遵循了研究设计。患者必须身体健康，有足够的骨来包裹种植体，并同意返回进行复诊。排除标准包括大量吸烟（每天>10支香烟）和种植体部位的骨增量手术。所有种植体均为两件式（愈合6周后放置基台），并具有经黏膜抛光的颈部。每个种植体都有SLA表面。所有种植体均采用非潜入式（单阶段）手术技术植入。通过生命表分析计算生存率和成功率。
共纳入706例患者，植入1406颗种植体。在最终分析中，590例患者的990颗种植体（占纳入患者的70.4%）符合所有纳入标准，包括在手术植入后63天内放置基台和临时修复。大多数种植体长10和12mm（78.7%），并植入II型和III型骨（87%）。73%的种植体植入下颌骨，27%植入上颌骨。3年时的累积生存率为99.56%，5年时为99.26%。3年时的总体成功率为99.12%，5年后为97.38%。
在私人执业条件下，具有SLA表面的种植体可在6至8周内可预测地植入和修复。这项前瞻性、多中心人体观察研究的数据强化了更正式临床研究的结果，并表明具有SLA表面的种植体在患者体内的修复时间约为传统愈合期的一半。
