国产种植体用于牙列缺损患者4年临床疗效随访研究

目的 评价国产Trausim骨水平种植系统用于固定修复牙列缺损患者的临床效果。方法 采用多中心、前瞻性、单组目标值法的临床试验设计，选择上海3家三甲医院作为研究中心，对120例牙列缺损患者进行种植修复，评价种植体成功率，记录种植体术后愈合感染情况、种植体周围骨吸收、种植体稳定性、种植体周围软组织健康状况等有效性指标。结果 受试者在修复负载4年后种植体成功率为97.5%,影像学检查种植体周围无透光区，颈部骨吸收均<1 mm,种植体周软组织健康并获得比较满意的功能修复效果。结论 Trausim种植体系统应用于牙列缺损患者修复效果良好，疗效确切，具有较高的成功率，能够满足临床应用。

A 4-year follow-up clinical research on domestic implant in patients with dental defect

Objective To observe and evaluate the clinical effect of Trausim bone level implant system on dental defect with a 4-year follow-up research. Methods A multi-centric, prospective, single-group target-value clinical trial design was used in this study. Three 3A hospitals in Shanghai were selected as the research center. One Hundred and twenty patients with dental defects were treated with implant therapy. The success rate was evaluated, and indexes such as postoperative healing, bone loss, soft tissue health around implants and implant stability were recorded. Results The results showed the implant success rate was 97.5% after 4 years of occlusal loading. X-ray examination showed that there was no transparent area around the implant and cervical bone resorption was less than 1 mm. The soft tissue around implants was healthy and the occlusal relation was functionally reconstructed. Conclusion Trausim bone level implant system is effective in the treatment of dental loss, with high success rate and low complication, which could be used in clinical practice.