Dr. Paul Moore and colleagues published a study of 4 percent articaine (Septocaine, Septodont, New Castle, Del.) in the November JADA article "The Anesthetic Efficacy of 4 Percent Articaine 1:200,000 Epinephrine: Two Controlled Clinical Trials" (
JADA 2006;137 [11]:1572–81
).
Dr. Moore is a paid consultant for Novocol Pharmaceutical of Canada (Cambridge, Ontario, Canada), which is known as Septodont (New Castle, Del.) in the United States, and was a site investigator for the original Septodont study. This study reported objective success rates of 42.8 percent for the inferior alveolar nerve injections and 88.2 percent with maxillary infiltrations. Also, the subjective test for a successful injection not only was profound anesthesia but also included "moderate but not complete feeling of numbness" after 10 minutes.
The article reports that one of the 80 patients with profound inferior alveolar anesthesia and one of the 187 patients with maxillary infiltrations had a paresthesia. However, the Septocaine package insert1 indicates there actually were three paresthesias. Although this study had three paresthesias in these 267 patients, the JADA authors report, "No serious adverse events occurred during the study."
This is reminiscent of the quote regarding the original Septodont study in Dr. Stanley Malamed and colleagues’2 May 2000 JADA article on the efficacy of articaine: "We found articaine to be well-tolerated in 882 subjects, and that it provided clinically effective pain relief during most dental procedures." However, the package insert1 indicates there were more than 11 paresthesias in the 882 patient treatments, whereas 21 paresthesias in the 882 patient visits were reported to the U.S. Food and Drug Administration (FDA).3
Dr. Moore’s article also lacked several references concerning 4 percent articaine and paresthesias. In 1996, Haas and Lennon4 reported in Journal of Dental Research that 95 percent of paresthesias in an Ontario, Canada, study in 1994 were associated with 4 percent articaine and 4 percent prilocaine.
A peer-reviewed article in Dentistry Today5 reported that 4 percent articaine had a paresthesia rate 20 times higher than that of 2 percent lidocaine. In Denmark, Hillerup and Jensen6 reported that articaine produced an incidence of injection injuries more than 20-fold higher. In the United States, the CRA Foundation Newsletter7 reported on paresthesia data from a large dental clinic that stopped using 4 percent articaine for mandibular block injections, and in 2005 the FDA required a new paresthesia warning in the package insert.1
The paresthesia rate for articaine can be determined by two FDA studies with the most reliable and valid study designs,3,8 which were reported by Malamed and colleagues2,9 and Moore and colleagues,10 and the authoritative package insert1 for articaine. The "adverse events" section of the package insert1 contains information on paresthesias in Table 1 from the first Septocaine study,3 Table 2 from the recent Septocaine study,8 a section on additional adverse events to the nervous system and the new statement at the conclusion of the section. On the basis of my review of the November JADA article by Dr. Moore and Table 2 of the package insert for articaine,1 I believe the paresthesia rate for articaine is one or two paresthesias in 80 profound inferior alveolar injections and one or two paresthesias in 187 maxillary infiltrations.
On the basis of Table 1 of the package insert,1 the paresthesia rate for 4 percent articaine is greater than one paresthesia for every 80 patient treatments regardless of injections, although the rate based on information submitted to the FDA would be one paresthesia for every 42 patient treatments.3
Until similarly designed studies demonstrate otherwise, I believe these are the scientific paresthesia rates with 4 percent articaine—and they create an unacceptable benefit:risk ratio for articaine compared with other local anesthetics.
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