EVALUATION OF A WETTING AGENT AS AN ADJUNCT FOR TAKING DENTAL IMPRESSION

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。由于牙齿结构断裂或腐烂，受试者必须戴上牙冠。牙齿将用高速手机和钻石切割条准备，这是由剩余的牙齿制成的印模。当一个装满软材料的托盘放进病人的口腔，放在钻孔的牙齿上，让它变硬时，就会形成牙印。印模硬化后，从口腔中取出。将对牙齿进行两种印模：一种使用润湿剂，另一种不使用润湿剂。这两个印模都将被送到牙医那里，牙医会把它们都放在病人的牙齿上(一次一个)。最好的牙冠将永久地粘在病人的牙齿上。对修复体适合性的评估将被用来确定使用和不使用润湿剂的印模材料的准确性。润湿剂是I类非重大风险设备，这意味着FDA不需要510(K)批准或IDE编号。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The subjects must need a crown due to fractured tooth structure or decay. Teeth will be prepared with high speed handpiece & diamond cutting bars & an impression made of the remaining tooth. A dental impression is made when a tray filled with soft material is placed into the patient's mouth & over the drilled tooth & allowed to harden. After the impression hardens, it is removed from the oral cavity. Two impressions will be made of the teeth: one with the wetting agent & one without the wetting agent. Both impressions will be sent to a dentist who will fit both of them on the patient's tooth (one at a time). The best crown will be cemented permanently onto the patient's tooth. The assessment of the fit of the restoration will be used to determine the accuracy of the impression material with & without the wetting agent. The wetting agent is a Class I, non-significant risk device, meaning the FDA does not require 510(k) approval or an IDE number.