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. 1995 Winter;4(4):272-5. doi: 10.1097/00008505-199500440-00007.
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 in anterior maxillary regions when used to support fixed prostheses. Observations were recorded before surgery, at first-stage surgery, at second-stage surgery, at loading, and at quarterly post-restoration prophylactic exams and annual comprehensive patient visits. Of 2,062 implants restored in 720 patients in the parent study, a total of 95 implants in 54 patients met the criteria for inclusion into this portion. 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. Post-restoration implant performance was analyzed using life-table methodology. No failures were observed before prosthodontic rehabilitation. Three implants failed during an observation period of up to 5 years after completion of prosthodontic treatment. The Cutler-Ederer life table success rate after 5 years was 93.4 percent. Results of this investigation suggest that threaded hydroxyapatite-coated implants are safe and effective when placed in anterior maxillary regions to support 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上颌前部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。在母研究的720例患者中植入的2062颗种植体中,共有54例患者的95颗种植体符合纳入该部分研究的标准。种植体失败标准包括松动、影像学显示骨吸收超过种植体长度的三分之一或种植体周围透射区、骨折、脱落、因任何原因取出以及患者自述触诊时疼痛。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。在修复前未观察到种植体失败。在修复治疗完成后的长达5年的观察期内,有3颗种植体失败。5年后的Cutler-Ederer寿命表成功率为93.4%。本研究结果表明,螺纹羟基磷灰石涂层种植体植入上颌前部区域以支持固定修复体时是安全有效的。