• J Orofac Pain · Jan 2011

    Randomized Controlled Trial Multicenter Study Comparative Study

    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.

    • Vianney Descroix, Amélie E Coudert, Alexandre Vigé, Jean-Pascal Durand, Steve Toupenay, Muriel Molla, Michel Pompignoli, Patrick Missika, and Francois-André Allaert.
    • Faculté de Chirugie Dentaire, Université Paris Diderot, Paris, France. vianney.descroix@free.fr
    • J Orofac Pain. 2011 Jan 1;25(4):327-32.

    AimsTo 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.MethodsThe 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.ResultsIndependent 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.ConclusionA 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.

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