Buchs A U, Hahn J, Vassos D M
Department of Oral and Maxillofacial Surgery, School of Dental Medicine, University of Pennsylvania, Philadelphia 19104-6003, USA.
Implant Dent. 1996 Summer;5(2):106-10.
A data subset from an ongoing prospective multicenter clinical study of threaded hydroxyapatite-coated implants was evaluated to assess safety and efficacy of the implants when used to support fixed prostheses in the posterior mandible. Observations were recorded before surgery, at first-stage surgery, at second-stage surgery, at loading, and at quarterly postrestoration prophylactic exams and annual comprehensive patient visits. Implant failure criteria included mobility, radiographic evidence of bone loss greater than one-third the length of the implant or peri-implant radiolucency, fracture, exfoliation, removal for any reason, and patient reported pain upon palpation. Soft tissue indices were monitored as part of the study. Postrestoration implant performance was analyzed using life-table methodology. From the 2,062 implants restored in 720 patients in the parent study, a total of 423 implants in 195 patients were included in the posterior mandibular data subset. Thirteen implants failed at or before second-stage surgery for a surgical success rate of 96.9 percent. Prosthodontics was completed, and one or more postrestoration annual follow-up visits occurred for 314 implants as of the interim analysis cutoff date. Fourteen implants failed during an observation period extending up to 62 months after completion of prosthodontic treatment. One failed implant was removed, whereas the 13 remaining implants are functional despite having been identified as failures under the protocol criteria. The Cutler-Ederer life table success rate after 5 years was 92.2 percent. Results of this investigation suggest that threaded hydroxyapatite-coated implants are effective when placed in posterior mandibular regions in support of fixed prostheses.
对一项正在进行的关于螺纹羟基磷灰石涂层种植体的前瞻性多中心临床研究中的一个数据子集进行了评估,以评估该种植体用于支持下颌后牙固定修复体时的安全性和有效性。在手术前、一期手术时、二期手术时、加载时以及修复后每季度的预防性检查和每年的全面患者复诊时记录观察结果。种植体失败标准包括松动、种植体长度三分之一以上的骨吸收或种植体周围透射区的影像学证据、骨折、脱落、因任何原因取出以及患者触诊时报告疼痛。作为研究的一部分,对软组织指标进行了监测。使用寿命表方法分析修复后种植体的性能。在母研究中,720名患者共植入了2062颗种植体,其中195名患者的423颗种植体被纳入下颌后牙数据子集。13颗种植体在二期手术时或之前失败,手术成功率为96.9%。完成了修复治疗,截至中期分析截止日期,314颗种植体进行了一次或多次修复后年度随访。在修复治疗完成后长达62个月的观察期内,有14颗种植体失败。1颗失败的种植体被取出,而其余13颗种植体尽管根据方案标准被判定为失败,但仍在发挥功能。5年后的Cutler-Ederer寿命表成功率为92.2%。本研究结果表明,螺纹羟基磷灰石涂层种植体植入下颌后牙区域支持固定修复体时是有效的。