Fischer Kerstin, Stenberg Torsten
Department of Oral and Maxillofacial Surgery, Falun, Sweden.
Int J Oral Maxillofac Implants. 2006 Mar-Apr;21(2):245-52.
The aim of this 3-year randomized controlled trial (RCT) was to compare biologic and technical treatment outcomes and patient satisfaction after early (< or = 14 days postimplantation) loaded implants with those of implants loaded after a healing period of 3 to 4 months in the edentulous maxilla.
Twenty-four patients with completely edentulous maxillae were randomized into a test group (n = 16) and a control group (n = 8). All patients received 5 or 6 solid screw-type titanium implants with sandblasted, large-grit, acid-etched (SLA) surfaces. In total, 142 implants were placed and 139 implants were loaded with full-arch prostheses. Clinical assessments were obtained at loading and after 3, 6, 12, 24, and 36 months. Radiographs of implants and existing teeth were taken at loading; after 6, 12, 24, and 36 months; and at 12, 24, and 36 months, respectively.
The cumulative implant success rate 3 years after loading was 100%. At the 3-year examination the mean (P < or = .005), distal (P < or = .005), and mesial (P > .05) crestal bone levels were better in the test group. No significant differences between the test and control groups were noted for any other outcome measure. The most common adverse event in both groups was tooth-crown fracture.
A review of the literature, both printed and electronic, revealed no study fulfilling the criteria of an RCT dealing with the early loading of maxillary full-arch prostheses. This study fulfills those criteria.
In this study population it has been concluded that the early (approximately 2 weeks) loading protocol is a viable alternative to the standard (3 to 4 months) protocol in the rehabilitation of a completely edentulous maxilla with a complete implant-supported fixed prosthesis.
这项为期3年的随机对照试验（RCT）旨在比较在上颌无牙区早期（植入后≤14天）加载种植体与愈合期3至4个月后加载种植体的生物学和技术治疗效果以及患者满意度。
24例上颌完全无牙的患者被随机分为试验组（n = 16）和对照组（n = 8）。所有患者均接受5颗或6颗带有喷砂、大颗粒、酸蚀（SLA）表面的实心螺旋型钛种植体。共植入142颗种植体，其中139颗种植体加载了全牙弓修复体。在加载时以及3、6、12、24和36个月后进行临床评估。在加载时、6、12、24和36个月后以及分别在12、24和36个月时拍摄种植体和现有牙齿的X光片。
加载后3年种植体的累积成功率为100%。在3年检查时，试验组的平均（P≤0.005）、远中（P≤0.005）和近中（P＞0.05）牙槽嵴骨水平更好。在任何其他结果指标方面，试验组和对照组之间均未发现显著差异。两组中最常见的不良事件是牙冠骨折。
对印刷和电子文献的回顾显示，没有一项符合RCT标准的研究涉及上颌全牙弓修复体的早期加载。本研究符合这些标准。
在本研究人群中得出的结论是，在使用完全种植体支持的固定修复体对上颌完全无牙进行修复时，早期（约2周）加载方案是标准（3至4个月）方案的可行替代方案。
