Division of Pharmacology and Therapeutics, Department of Oral Surgery and Pharmacology, School of Dental Medicine, University of Pennsylvania, 240 S. 40th St., Philadelphia, Pa. 19104-6030, USA.
J Am Dent Assoc. 2013 May;144(5):517-26. doi: 10.14219/jada.archive.2013.0154.
The authors evaluated the efficacy and tolerability of 10 percent and 20 percent benzocaine gels compared with those of a vehicle (placebo) gel for the temporary relief of toothache pain. They also assessed the compliance with the label dose administration directions on the part of participants with toothache pain.
Under double-masked conditions, 576 participants self-applied study gel to an open tooth cavity and surrounding oral tissues. Participants evaluated their pain intensity and pain relief for 120 minutes. The authors determined the amount of gel the participants applied.
The responders' rates (the primary efficacy parameter), defined as the percentage of participants who had an improvement in pain intensity as exhibited by a pain score reduction of at least one unit on the dental pain scale from baseline for two consecutive assessments any time between the five- and 20-minute points, were 87.3 percent, 80.7 percent and 70.4 percent, respectively, for 20 percent benzocaine gel, 10 percent benzocaine gel and vehicle gel. Both benzocaine gels were significantly (P ≤ .05) better than vehicle gel; the 20 percent benzocaine gel also was significantly (P ≤ .05) better than the 10 percent benzocaine gel. The mean amount of gel applied was 235.6 milligrams, with 88.2 percent of participants applying 400 mg or less.
Both 10 percent and 20 percent benzocaine gels were more efficacious than the vehicle gel, and the 20 percent benzocaine gel was more efficacious than the 10 percent benzocaine gel. All treatments were well tolerated by participants. Practical Implications. Patients can use 10 percent and 20 percent benzocaine gels to temporarily treat toothache pain safely.
作者评估了 10%和 20%苯佐卡因凝胶与载体（安慰剂）凝胶相比在缓解牙痛方面的疗效和耐受性。他们还评估了牙痛患者对标签剂量使用说明的依从性。
在双盲条件下，576 名参与者将研究凝胶自行涂抹到开放的牙洞和周围口腔组织上。参与者评估了他们在 120 分钟内的疼痛强度和缓解程度。作者确定了参与者使用的凝胶量。
应答者的比例（主要疗效参数）定义为疼痛强度改善的参与者比例，表现为在连续两次评估中，从基线开始的至少一个单位的牙科疼痛量表上的疼痛评分减少，在 5 分钟至 20 分钟之间的任何时间点，20%苯佐卡因凝胶、10%苯佐卡因凝胶和载体凝胶的比例分别为 87.3%、80.7%和 70.4%。两种苯佐卡因凝胶均明显优于载体凝胶（P≤0.05）；20%苯佐卡因凝胶也明显优于 10%苯佐卡因凝胶（P≤0.05）。平均应用凝胶量为 235.6 毫克，88.2%的参与者应用量在 400 毫克或以下。
10%和 20%苯佐卡因凝胶均比载体凝胶更有效，20%苯佐卡因凝胶比 10%苯佐卡因凝胶更有效。所有治疗均被参与者耐受良好。实际意义。患者可以使用 10%和 20%苯佐卡因凝胶安全地临时治疗牙痛。
