Objective: The objective of these two double blind, randomized, three-center crossover studies was to determine the efficacy and clinical anesthetic characteristics of 4% articaine HCl with 1:200,000 epinephrine (A200) as compared to 4% articaine HCl with 1:100,000 epinephrine (A100) and 4% articaine HCl without epinephrine (Aw/o) following their administration for mandibular block (1.7mL) or maxillary infiltration anesthesia (1.0mL). Methods: The three anesthetic study medications (A100, A200, and Aw/o) were administered in Trial #1 to induce mandibular block anesthesia and in Trial #2 to induce maxillary infiltration anesthesia. In each trial, subjects received all three anesthetic formulations to determine efficacy (success rate) and anesthetic characteristics (onset time and duration). Results: In Trial #1, 62 subjects (36 male, 27 female) and in Trial #2, 62 subjects (28 male, 35 female) completed the protocol. Profound anesthesia (EPT value = 80) was achieved following mandibular block as follows: A100 = 47.6 %, A200 = 54,8% and Aw/o= 25.8%. Profound anesthesia was achieved following maxillary infiltration anesthesia as follows: A100 = 95.2 %, A200 = 93.5% and Aw/o= 75.8%. There were no significant differences in the onset and duration of infiltration anesthesia between the A200 and A100 treatments: onset (3.1 + 2.3 minutes A200 vs. 3.0 + 2.1 minutes A100) or duration (41.6 + 21.1 minutes A200 vs. 45.0 + 23.6 minutes A100). There were also no differences in onset and duration of mandibular block anesthesia between the A100 and A200 treatments: onset (4.7 +2.6 min A200 vs. 4.2 +2.8 min A100) or duration (51.2 + 55.9 min. A200 vs. 61.8 + 59.0 min A100). Conclusion: This study confirmed the safety and efficacy of 4% articaine HCl with 1:200,000 epinephrine for use as a local dental anesthetic for maxillary infiltration and mandibular block anesthesia.
Supported through a contract from Novocol Pharmaceutical of Canada, Inc.