Fischer Kerstin, Stenberg Torsten
Department of Oral and Maxillofacial Surgery, County Hospital, SE-791 82 Falun, Sweden.
Int J Oral Maxillofac Implants. 2004 May-Jun;19(3):374-81.
This prospective, randomized study investigated the safety, feasibility, and reliability of the early loading of implants in edentulous maxillae.
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. These were loaded with full-arch prostheses after 9 to 18 days in the test group and after 2.5 to 5.1 months in the control group. Periapical radiographs were taken and routine clinical assessments were made at loading, after 6 months, and after 12 months.
The implant survival rate 1 year after loading was 100%. Modified Plaque index scores and Sulcus Bleeding index scores were better in the test group than in the control group (P < or = .05). There was a significant difference in peri-implant bone height between the 2 groups (P < .001) and this difference converged with time (P < .001).
This clinical, prospective, randomized, controlled study fulfilled the criteria for a comparable study. Owing to the small patient sample, the conclusions drawn were based on feasibility analyses of the results. Standard materials and methods were used. Only patients with maxillary bone of sufficient height and width were selected. The use of a single operator in each discipline--maxillofacial surgery, prosthodontics, and dental technology--may have improved the chances of achieving consistent standards and opinions.
These results indicate that early loading in selected patients was as safe and reliable as delayed loading in this small patient population and may offer a satisfactory alternative to the standard protocol.
本前瞻性随机研究调查了在上颌无牙颌中早期加载种植体的安全性、可行性和可靠性。
24例上颌完全无牙颌患者被随机分为试验组(n = 16)和对照组(n = 8)。所有患者均植入5或6枚实心螺旋型钛种植体。试验组在9至18天后用全牙弓假体加载,对照组在2.5至5.1个月后加载。在加载时、6个月后和12个月后拍摄根尖片并进行常规临床评估。
加载1年后种植体存活率为100%。试验组的改良菌斑指数评分和龈沟出血指数评分优于对照组(P≤0.05)。两组种植体周围骨高度存在显著差异(P < 0.001),且这种差异随时间逐渐缩小(P < 0.001)。
这项临床前瞻性随机对照研究符合可比研究的标准。由于患者样本量较小,得出的结论基于对结果的可行性分析。采用了标准的材料和方法。仅选择了上颌骨高度和宽度足够的患者。每个学科(颌面外科、口腔修复学和牙科技术)由单一操作者进行操作,这可能提高了达到一致标准和观点的机会。
这些结果表明,在这一小部分患者中,对选定患者进行早期加载与延迟加载一样安全可靠,可能为标准方案提供令人满意的替代方案。