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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。由于牙齿结构断裂或龋齿，患者必须安装牙冠。牙齿将用高速机头和钻石切割棒准备，并用剩余的牙齿做一个印痕。当一个装满软质材料的托盘放入患者的口腔并盖住钻出的牙齿并让其变硬时，就会形成牙印。待印模变硬后，从口腔中取出。将对牙齿进行两次印模：一次使用润湿剂，一次不使用润湿剂。这两个印模将被送到牙医那里，牙医会把它们都装在病人的牙齿上（一次一个）。最好的牙冠会被永久地粘在病人的牙齿上。修复贴合的评估将用于确定有润湿剂和没有润湿剂的压模材料的准确性。润湿剂是一类非显著风险设备，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.