Anderson R J, Janes G R, Sabella L R, Morris H F
Department of Veterans Affairs Hospital, Hines, Ill.
J Prosthet Dent. 1993 Jan;69(1):1-8. doi: 10.1016/0022-3913(93)90230-l.
In a 10-year, multicenter, double-blind clinical trial, comparisons of the clinical behavior of crown and fixed partial denture restorations were made between a gold alloy and four less costly alternative alloys. The endpoints of interest were (1) the development of unacceptable ratings on any of 11 individual prosthodontic criteria and an overall rating, (2) the removal of the restoration, and (3) an event combining unacceptable overall rating and restoration removal. Each of 630 patients had two restorations completed, one from gold-palladium alloy and the other from one of four alternative alloys. The patients were enrolled during a period of 3 1/2 years, with some patients followed up as long as 10 years after restoration. Analysis of the endpoints showed that one of the alternative alloys was significantly poorer than the other materials for certain criteria.
在一项为期10年的多中心双盲临床试验中,对一种金合金与四种成本较低的替代合金的冠修复体和固定局部义齿修复体的临床性能进行了比较。感兴趣的终点指标为:(1)在11项个别修复标准中的任何一项及总体评级上出现不可接受的评级;(2)修复体的拆除;(3)将不可接受的总体评级与修复体拆除相结合的事件。630名患者每人完成了两种修复体,一种是金钯合金修复体,另一种是四种替代合金中的一种修复体。患者入组时间为3年半,部分患者在修复后随访长达10年。对终点指标的分析表明,对于某些标准,其中一种替代合金明显比其他材料差。