USE OF OXYMETAZOLINE TO CONTROL BLEEDING IN SELECTED DENTAL PROCEDURES

当牙医在牙龈线或牙龈线以下工作时，控制出血非常困难。最常用于此目的的药物（肾上腺素）是短效的，并有可能增加患者的心率和血压。本研究的目的是测试长效药物（羟甲唑啉）在牙科手术中控制出血的疗效，并确定其对心率和血压的影响，当它以这种方式使用。将招募约六十（60）名志愿者，以选择研究所需的二十九（29）名受试者。在研究开始（筛选阶段）之前，所有志愿者将向一般临床研究中心（GCRC）报告，进行体格检查、口腔检查和实验室评价（通过血液采样），以验证健康、稳定的身体状态并提供基线参数。本研究包括以下内容：a。本研究（研究阶段）将需要对入选的受试者在一般临床研究中心（GCRC）进行一次额外访视。在这次访问期间，牙医将在其中一颗上牙周围放置一根牵开绳（一根绳子），并将绳子留在原位10分钟，然后将其取出。放置绳子的区域将被监测出血55分钟。第二根牵开绳将围绕口腔另一侧的另一颗上牙放置10分钟。然后将其移除，并再次监测该区域额外55分钟的出血情况。其中一条牵引绳将使用测试药物羟甲唑啉，另一条将使用安慰剂，乌藨子草莓味水。当受试者参与研究时，每5分钟用标准化压敏牙周（牙科）探针在所选牙齿周围施加20克压力。施加的压力将用于诱导少量出血，这是确定含药牵开索中的试验药物（羟甲唑啉）是否有效所需的。在许多牙科研究中，探查引起轻微出血已被用作预防措施。这个过程是相同的牙周探测完成的一部分，例行牙科检查和预防（清洁）。这也模拟了牙医制作延伸到牙龈线以下的牙齿预备印模所需的组织操作。

Controlling bleeding is very difficult when dentists are working at or below the gum line. The drug most commonly used for this purpose (epinephrine) is short acting and has the potential to increase the patient's heart rate and blood pressure. The purpose of this study is to test the efficacy of a long-acting drug (oxymetazoline) for controlling bleeding in dental procedures and to determine its effect on heart rate and blood pressure when it is used in this manner. Approximately sixty (60) volunteers will be recruited to select the twenty-nine (29) subjects needed for the study.Prior to initiation of the study (Screening phase) all volunteers will report to the General Clinical Research Center (GCRC) for a physical examination, oral examination and laboratory evaluation (by blood sampling) to verify a healthy, stable physical state and to provide baseline parameters. The research consists of the following: a. The study (Study phase) will require one additional visit to the General Clinical Research Center (GCRC) for those subjects selected to participate. During this visit the dentist will place a retraction cord (piece of string) around one of the upper teeth and leave the cord in place for 10 minutes, then remove it. The area where the cord was placed will be monitored for bleeding for 55 minutes. A second retraction cord will be placed around another upper tooth on the other side of the mouth for 10 minutes. Then it will be removed and again the area will be monitored for an additional 55 minutes for bleeding. One of the retraction cords will be medicated with the test drug, oxymetazoline, and the other will be the placebo, raspberry-strawberry flavored water. Every 5 minutes while the subjects are participating in the study, 20 grams of pressure will be applied around the selected teeth with a standardized pressure sensitive periodontal (dental) probe. The applied pressure will be used to induce a small amount of bleeding which is needed to determine if the test drug (oxymetazoline) in the medicated retraction cord is effective. Probing to induce minor bleeding has been used as an adjunctive measure in many dental studies. This procedure is identical to the periodontal probing completed as part of a routine dental examination and prophylaxis (cleaning). This also simulates the tissue manipulation that is required as dentists make impressions of tooth preparations that extend below the gum line.