USE OF OXYMETAZOLINE TO CONTROL BLEEDING IN SELECTED DENTAL PROCEDURES

当牙医在牙龈线或以下工作时，控制出血是非常困难的。最常用于此目的的药物（肾上腺素）是短效的，有可能增加病人的心率和血压。本研究的目的是测试一种长效药物（oxymetazoline）在牙科手术中控制出血的功效，并确定其在这种方式下使用时对心率和血压的影响。大约六十（60）名志愿者将被招募来选择研究所需的二十九（29）名受试者。在研究开始之前（筛选阶段），所有志愿者将到普通临床研究中心（GCRC）进行体检、口腔检查和实验室评估（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。研究包括以下内容：a.研究（研究阶段）将要求被选中参与的受试者额外访问普通临床研究中心（GCRC）。在这个过程中，牙医会在上面的一颗牙齿周围放上一根牵索（一根绳子），让牵索在原地停留10分钟，然后取出。放置脐带的地方将进行55分钟的出血监测。在口腔另一侧的另一颗上牙周围放置第二根牵索10分钟。然后将其取出，并再次对该区域进行55分钟的出血监测。其中一根收缩索将使用测试药物oxymetazoline，另一根将使用安慰剂覆盆子草莓味水。在受试者参与研究期间，每隔5分钟，将用标准化压力敏感牙周（牙科）探针在选定的牙齿周围施加20g压力。施加的压力将被用来诱导少量出血，这是需要确定药物牵拉索中的测试药物（oxymetazoline）是否有效。在许多牙科研究中，探探诱发少量出血已被用作辅助措施。这个程序与作为常规牙科检查和预防（清洁）的一部分完成的牙周探诊相同。这也模拟了组织操作，这是牙医在牙龈线以下进行牙齿准备的印模所需要的。

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.