The clinical anesthetic efficacy of 3% mepivacaine in infiltration and block anesthesia was examined at 7 institutions (Table 1) in a double blind study of 231 dental patients (Table 2). NSY-101 (3% mepivacaine hydrochloride without any vasoconstrictor as the N group) was evaluated for its clinical availability and compared with 2% lidocaine hydrochloride with 1:80,000 epinephrine as the L group. Clinical equivalency in the success rate was compared between the two groups ; 95.7% in the N group and 98.1% in the L group (Table 3). The L group showed a significantly longer duration of soft tissue symptoms (Table 6). Except for a single local adverse reaction consisting of a slight subcutaneous hemorrhage in the L group, there were no notable changes in blood pressure, heart rate, RPP in any of the patients tested (Table 8). "Clinical availability" is defined as a combination of the success rate and the safety rate including the duration of numbness. The 91.4% "clinically available rate" in the N group was proven clinically equivalent to 91.6% in the L group. In addition, the N group was superior to the L group in the "remarkably available rate". The results showed that NSY-101 was as effective as 2% lidocaine hydrochloride with 1:80,000 epinephrine (Table 3, 4). The shorter duration of NSY-101 (Table 6, 7) is an advantage in that prolonged lip numbness is avoided. NSY-101 was, occasionally less effective in cases of mandibular molars affected by acute inflammation as well as in treatments over thirty minutes (Table 5). However, the significant advantage in safety of vasocon. strictor-free NSY-101 makes it preferable for upgraded dental treatment.
|Number of pages||14|
|Journal||Journal of Japanese Dental Society of Anesthesiology|
|Publication status||Published - 2002|
- Local anesthetics
- Multi center double blind clinical study
ASJC Scopus subject areas
- Anesthesiology and Pain Medicine