title: 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.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Faculté de Chirugie Dentaire, Université Paris Diderot, Paris, France. vianney.descroix@free.fr
authors.forename: Vianney
authors.initials: V
authors.lastname: Descroix
authors.forename: Amélie E
authors.initials: AE
authors.lastname: Coudert
authors.forename: Alexandre
authors.initials: A
authors.lastname: Vigé
authors.forename: Jean-Pascal
authors.initials: JP
authors.lastname: Durand
authors.forename: Steve
authors.initials: S
authors.lastname: Toupenay
authors.forename: Muriel
authors.initials: M
authors.lastname: Molla
authors.forename: Michel
authors.initials: M
authors.lastname: Pompignoli
authors.forename: Patrick
authors.initials: P
authors.lastname: Missika
authors.forename: Francois-André
authors.initials: FA
authors.lastname: Allaert
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000779:Anesthetics, Local / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects / Q000293:injuries*; D009824:Ointments; D010147:Pain Measurement; D010919:Placebos; D013281:Stomatitis, Aphthous / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000779:Anesthetics, Local; D009824:Ointments; D010919:Placebos; D008012:Lidocaine