口腔印模材料最重要的性能是精确的复制口腔软硬组织的形态，通过印模材料灌注石膏模型的准确性和精度，直接影响到修复体的精确性和质量。硅橡胶印模材料是国内外制作口腔固定修复体最常用的材料之一，我国应用的硅橡胶印模材料主要是进口材料。国产安泰硅橡胶印模材料属于加成型硅橡胶印模材料，已获得了国家食品药品监督管理局北大医疗器械质量监督检验中心核发的注册检验合格报告，本研究的目的是对于国产安泰硅橡胶印模材料的临床操作性能、生物学性能以及印模的精确性进行临床应用观察试验。本研究包括以下三个内容。

试验一：安泰硅橡胶印模材料的临床操作性能观察

试验目的：通过与康特Rapid硅橡胶印模材料进行等效性对比，观察安泰硅橡胶印模材料各项口腔临床操作指标是否符合临床操作要求。

材料与方法：选取40例上颌或者下颌牙列基本完整患者，男性12名，女性28名，在同一牙弓分别用安泰硅橡胶印模材料和康特Rapid硅橡胶印模材料各制取一个全牙弓印模，共获得40对印模，观察并记录安泰硅橡胶印模材料的下列临床操作性能：混合均匀性、操作易否、工作时间、从口腔取出的完整性、印模的清晰程度、是否出现脱模、能否与石膏模型完整分离、有无粘膜过敏不良反应。

结果：安泰硅橡胶能达到混合均匀，易于操作，工作时间在3-5分钟，可以从口腔中完整地取出，印模清晰，未出现托模现象，灌注石膏模型后易与石膏模型分离，无粘膜过敏不良反应。

结论：安泰硅橡胶印模材料各项临床功能操作指标均达到临床应用标准的范围，符合临床操作要求。

试验二：测量对比安泰和康特硅橡胶印模灌注的石膏模型的精确性

试验目的：测量对比以国产安泰硅橡胶印模和康特Rapid硅橡胶印模灌注的石膏模型的精确性。

材料与方法：利用本研究试验一所制取的40对全牙弓硅橡胶印模灌注成40对全牙弓超硬石膏模型，对前牙、后牙以及两侧后牙进行相同牙位及相同点的标记，用Kestrel Vision工具显微镜测量40对石膏模型的长Lx和宽Ly，测量值精确到微米。运用配对T检验对两组的测量结果进行统计分析。

结果：Lx差值范围0.004mm-0.0101mm;P值=0.381，无显著性差异

     Ly差值范围0.103mm-0.105mm;P值=0.984，无显著性差异

结论：安泰硅橡胶印模材料与康特Rapid硅橡胶印模材料具有相同的精确度。

试验三：密合膜法对比以安泰和康特硅橡胶印模制作的全冠的临床密合度

试验目的：测量对比以安泰硅橡胶印模和康特Rapid硅橡胶印模的精确性制作的全冠的临床密合度，进一步观察印模临床应用的精确性。

材料与方法：随机抽取5例需要进行前牙或双尖牙金合金-烤瓷全冠修复的患者，同一牙位以安泰和康特硅橡胶印模配对制作全冠修复体并以聚醚间隙膜的厚度为指标测量对比冠的密合度。

结果：以安泰硅橡胶印模和康特Rapid硅橡胶印模制作的全冠间隙膜厚度差在30μm内。

结论：以安泰硅橡胶与康特Rapid硅橡胶印模材料制作的全冠符合临床密合度的要求。

Silicone rubber impression material is one of the most commonly used produced in fixed oral prosthesis at home and abroad. And our application of silicone rubber impression material is mainly imported materials. Silicone rubber impression materials made in Antai is Vinyl Polydimethyl Siloxane(VPS).It has already received the report from State Drug Administration—Medical Devices Quality Supervision and Testing Centre of Peking University. The aim of the research is evaluate the manipulation in the clinic and the accuracy of the silicone impression which is produced by demostic An Tai company. The research includes three parts:

Experiment 1 The observe of the silicone rubber impression material made in Antai in clinical performance.

Purpose. Observe the silicone rubber impression material made in Antai through the comparison between Coltène/Whaledent Rapid and Antai used in clinical operation.

Material and methods. Selected 40 cases of patients with almost integral dentition in Maxillary or mandibular. 12 males and  28 femals. Making two impressions in the same dentition with Rapid and Antai silicone rubber impression material. And 40 couples of  impressions in all. The observation index as follow: the situation of mixing, manipulation, the time of solidification, mucosa situation and other index of the manipulation.

Results. The silicone rubber impression material can be mixed balancely, easy to use, working time within 3-5min,can be taken out of the mouth compeletly, has good accuracy, can be separated with tray and the plaster model easily, has no mucosa allergic reaction.

Conclusions. The result shows that the indicators are the acceptable in clinic, according to the requirements of clinical operations.

Experiment 2  Measuring the accuracy of plaster models made with Antai and Rapid silicone rubber.

Purpose. Measure and compare the accuracy of plaster models made with Antai and Rapid silicone rubber.

Material and methods. Making 40 couples of plaster models with the 40 couples of silicone rubber impressions made in experiment 1. Mark the points on the incisors and molars and ensure the length Lx and width Ly with Kestrel Vision microscope. The accuracy is micron. Statistics the numbers with Paired Samples T-Test.

Results: Lx: 95% Confidence Interval of the Difference is 0.004-0.101. P=0.381. Ly: 95% Confidence Interval of the Difference is 0.103-0.105. P=0.984.

Conclusion: The result shows the accuracy of the two kinds of silicone rubber impression materials are the same.

Experiment 3: Comparision of fitness of crown made with Rapid and Antai silicone rubber impression.

Purpose. Measure and compare of fitness of crown made by Rapid and Antai silicone rubber impression. Observe the clinical accuracy of the silicone rubber impression.

Material and methods. Select 5 patients need gold alloy-ceramic crown restoration in incisors or premolars. Make two impression with Rapid and Antai silicone rubber impression on the same tooth. And make the crown simultaneously. Measure the thickness of the polyether membrane. It shows the fitness of the crown.

Results. The different of the thickness of the membrane is within 30μm .

Conclusion. The crowns made by Rapid and Antai silicone rubber impression are suit to the clinical accuracy.

目录 -------------------------------------------------------------- 3

中文摘要 ---------------------------------------------------------- 4

英文摘要 ---------------------------------------------------------- 7

文献综述 ---------------------------------------------------------- 9

论文正文 --------------------------------------------------------- 18

 试验一 安泰硅橡胶印模材料的临床操作性能观察---------------------- 18

 试验二 测量对比安泰和康特硅橡胶印模灌注的石膏模型的精确性-------- 25

 试验三 密合膜法对比以安泰和康特硅橡胶印模制作的全冠的临床密合度--------------------------------------------------------- 33

全文总结 --------------------------------------------------------- 37

参考文献 --------------------------------------------------------- 38

致谢 ------------------------------------------------------------- 43

个人简历 --------------------------------------------------------- 44