ABSTRACT
BACKGROUND: Phentolamine mesylate (PM) is widely used to reverse local anesthesia after dental procedures. Limited knowledge is available regarding effectiveness and safety in routine dental practice. METHODS: The authors conducted 2 national, prospective, noninterventional, postauthorization effectiveness studies (OraVerse Post-Authorization Efficacy Study [ORAPAES] controlled, OraVerse Non-Interventional Study [ORANIS] uncontrolled) in patients receiving a local anesthetic as part of their dental treatment. They investigated time to recovery of normal sensation and function and the frequency of adverse events (AEs). The authors used Kaplan-Meier methods to analyze times to recovery; in ORAPAES, they used hazard ratios based on Cox models using the control group as a reference. RESULTS: In ORAPAES (n = 856), PM reduced the time to recovery of normal sensation and function with a difference in the median time of 70 and 79 minutes, respectively, with similar results observed in ORANIS (n = 445). In ORAPAES, patients in the PM group had, at any time point, a 2.77-fold higher chance of recovery to normal sensation (hazard ratio, 2.77; 95% confidence interval [CI], 2.35-3.26; P < .001) and for normal function 2.94-fold higher chance of recovery to normal sensation (95% CI, 2.49-3.47; P < .001) than in the control group. The observed incidence of AEs with PM treatment was 8.4% in ORAPAES (95% CI, 6.2-10.9) and 9.7% (95% CI, 7.1-12.7) in ORANIS. No serious AEs occurred. CONCLUSIONS: PM substantially reduced the time to recovery of normal sensation and function after local anesthesia in routine dental treatment. The results confirm the effectiveness, safety, and tolerability of PM used in patients with routine dental conditions in Germany, and that PM augments the safety of dental treatments. PRACTICAL IMPLICATIONS: The authors determined that PM is well suited to reverse local anesthesia after routine dental procedures.
