USE OF OXYMETAZOLINE TO CONTROL BLEEDING IN SELECTED DENTAL PROCEDURES

在特定牙科手术中使用羟甲唑啉控制出血

• 批准号: 6297162
• 负责人: EDDIE L BOYD
• 金额: $ 0.02万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6297162
• 关键词: adrenergic agents; blood pressure; clinical research; dental agent; dental pharmacology; drug screening /evaluation; gingiva; gingival sulcus; heart rate; hemorrhage; human subject; imidazole; slow release drug

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.

当牙医在牙周线以下工作时，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，有可能提高患者的心率和血压。本研究的目的是测试一种长效药物(羟甲唑啉)在牙科手术中控制出血的效果，并确定其在以这种方式使用时对心率和血压的影响。大约60名志愿者将被招募来选择研究所需的29名受试者。在研究开始之前(筛选阶段)，所有志愿者将向综合临床研究中心(GCRC)报到进行体检、口腔检查和实验室评估(通过采血)，以验证健康、稳定的身体状态并提供基线参数。这项研究包括以下内容：a.研究(研究阶段)将要求被选中参加研究的受试者再去一次综合临床研究中心(GCRC)。在这次访问中，牙医将在上牙的一颗牙齿周围放置一根拉线(一根线)，并将线放在适当的位置10分钟，然后将其拔出。放置脐带的区域将被监测55分钟是否出血。第二根牵引线将绕在口腔另一侧的另一颗上牙上，持续10分钟。然后将其移除，并再次对该区域进行额外的55分钟出血监测。其中一根牵引线将被注入测试药物羟甲唑啉，另一根将被注入安慰剂、覆盆子-草莓口味的水。在受试者参与研究期间，每隔5分钟，将用标准化的压敏牙周(牙科)探头在选定的牙齿周围施加20克压力。施加的压力将被用来诱导少量出血，这是确定含药回缩索中的测试药物(羟甲唑啉)是否有效所必需的。在许多牙科研究中，探查以引起轻微出血已被用作辅助措施。此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查相同。这也模拟了牙医对延伸到牙周线以下的牙齿准备留下印记时所需的组织处理。