Clinical Efficacy and Tolerability of a New Experimental Mucoadhesive Patch for Topical Anesthesia of Oral Mucosa in Pediatric Dentistry.

Background : The injection of local anesthetics is the procedure that still causes the most fear and anxiety in a dental session; to minimize this problem, we can use topical anesthesia. The aim of this study is to analyze the tolerability and the clinical efficacy in the control of pain, during the subsequent injection of the local anesthetic, of an experimental anesthetic patch with a new formulation, which was previously tested in gel formula. Methods : A total of 150 children, aged 4 to 9 years, were included in the study. Each patient was treated using three different pre-anesthesia methods (placebo gel, experimental gel, and experimental patch), according to a split-mouth procedure, within a week of each other. The injection pain was analyzed using the WBFPRS and FLACC scales. Patients' caregivers' satisfaction was recorded at the end of the procedures. The data were analyzed using one-way ANOVA-RM, Wilcoxon-Mann-Whitney, Mann-Whitney U, and χ 2 tests. Results : In this study, significantly higher pain ratings were observed with the topical placebo gel and lower pain ratings were observed with the experimental patch. Conclusion : The use of the patch proved to be very effective in reducing pain both subjectively and objectively, in the absence of both local and systemic side effects, validating its use in the oral mucosa.