Does Unidirectional Buccal Patches Loaded With Lidocaine and Dexmedetomidine Ameliorate Injection Pain in Dental Procedures? A Double-Blinded Randomized Controlled Trial

Abstract

Introduction: Dental anxiety is a critical issue in dentistry. Buccal patches, a noninvasive drug delivery method, can potentially alleviate anxiety and pain during dental procedures. This study aimed to develop a three-layered buccal drug delivery system containing lidocaine or lidocaine-dexmedetomidine for improved pain management in dentistry.Methods: Three-layered patches were made using ethyl cellulose, eudragit, and Carbopol, incorporating either lidocaine or a combination of lidocaine-dexmedetomidine. Forty participants were included: Both groups received placebo patches on one side of jaw and received their relevant drug patch of lidocaine or lidocaine-dexmedetomidine on the other side. Pain levels were assessed.Results: The patches were 2-3 mm thick with a pH of 3.5-4.5. Lidocaine release efficiency was 41.69 +/- 13.10, and the combination patches showed 47.17 +/- 5.10 for lidocaine and 74.71 +/- 6.41 for dexmedetomidine. Release time for lidocaine and the combination patch was 25 and 15 min, respectively, with dexmedetomidine fully released within 3 min. The lidocaine-dexmedetomidine group reported significantly lower pain scores (2.1 +/- 0.3) compared to the lidocaine group (4.3 +/- 0.4) and placebo (6.8 +/- 0.5). The onset and duration of analgesia was faster in the combination group versus the lidocaine group (5.2 +/- 0.5 vs. 8.7 +/- 0.6 min and 45 +/- 5 vs. 30 +/- 4 min, respectively).Conclusion: Buccal patches, especially lidocaine-dexmedetomidine patches, significantly reduce pain and improve patient comfort. These patches offer a promising noninvasive alternative for pain management with enhanced efficacy and patient compliance. Further research is needed to optimize these patches for broader clinical applications.Trial Registration: Iranian Clinical Trials Registration Center: