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.
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