Evaluating Pain Response and Clinical Efficacy of an Articaine Mucoadhesive Patch among 6-12-year-old Children during Local Anesthetic Injection and Subgingival Tooth Preparation: A Double-blind Nonrandomized Clinical Trial.

Background: Pain management is crucial in pediatric dentistry to ensure patient comfort and foster positive attitudes toward dental care. Local anesthesia is essential for pain control, but the injection process often causes fear and anxiety in children. Topical anesthetics are used to alleviate injection-associated pain; however, conventional anesthetics lack sufficient adhesion and efficacy. Aim: This study evaluated the clinical efficacy of a novel articaine mucoadhesive (AMA) patch formulated with 4% articaine for pain control during local anesthetic injections (inferior alveolar nerve block) and subgingival tooth preparation for stainless steel crown (SSC) placement. Materials and methods: The Institutional Ethics Committee approved the study design (CDCRI/DEAN/ETHICSCOMMITTEE/PEDO/PG-02/2024). The study was conducted with 60 children aged 6-12 divided into two groups: local anesthetic site (inferior alveolar nerve block) and tooth preparation for SSC. Each group was further divided into subgroups that received either the articaine or placebo patches. Pain responses were assessed using sound-eye-motor (SEM) and visual analog scale (VAS) scores. A significance level of 5% was used for the analysis. Shapiro-Wilk and Mann-Whitney U tests were used to assess the data. Results: The AMA patch significantly reduced pain compared to the placebo (p = 0.001). The SEM and VAS scores for the articaine patch were 1.236 and 2.102 (local anesthetic site), and 1.547 and 2.477 (tooth preparation for SSC), respectively. There were no statistically significant differences between the groups (p > 0.7). Conclusion: The AMA patch demonstrated effective pain reduction during local anesthetic injection and tooth preparation, offering promising results for pediatric pain management, with enhanced compliance and localized effects. How to cite this article: Dhote S, Deoghare A, PJ N, et al. Evaluating Pain Response and Clinical Efficacy of an Articaine Mucoadhesive Patch among 6-12-year-old Children during Local Anesthetic Injection and Subgingival Tooth Preparation: A Double-blind Nonrandomized Clinical Trial. Int J Clin Pediatr Dent 2025;18(9):1097-1102.