Efficacy of topical 1% lidocaine in the symptomatic treatment of pain associated with oral mucosal trauma or minor oral aphthous ulcer: a randomized, double-blind, placebo-controlled, parallel-group, single-dose study

J Orofac Pain. Fall 2011;25(4):327-32.


Aims: To determine the efficacy in pain reduction of a topical 1% lidocaine compared to a placebo cream in patients with oral mucosal lesions due to trauma or minor oral aphthous ulcer.

Methods: The design was a double-blind, randomized, placebo-controlled, six-center trial on 59 patients. Pain intensity and relief were measured using a 100-mm visual analog scale (VAS). One-tailed Student t test and ANOVA analyses were used for statistical analyses.

Results: Independent of the pain origin (oral mucosal trauma or minor oral aphthous ulcer), the application of the 1% lidocaine cream led to a mean reduction in VAS pain intensity of 29.4 mm ± 17.0, which was significantly greater than the decrease obtained with the placebo cream. Analysis showed a statistically significant efficacy of the 1% lidocaine cream (P = .0003). Its efficacy was not related to the type of lesion, and no adverse drug reaction, either local or systemic, was reported by any of the patients.

Conclusion: A significant reduction in pain intensity occurred after application of 1% lidocaine cream and was significantly greater than that with the placebo cream. Taking into account the study's limitations, this product seems safe to use.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anesthetics, Local / administration & dosage*
  • Double-Blind Method
  • Female
  • Humans
  • Lidocaine / administration & dosage*
  • Male
  • Middle Aged
  • Mouth Mucosa / drug effects
  • Mouth Mucosa / injuries*
  • Ointments
  • Pain Measurement
  • Placebos
  • Stomatitis, Aphthous / drug therapy*
  • Young Adult


  • Anesthetics, Local
  • Ointments
  • Placebos
  • Lidocaine