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

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: IRCT20210118050067N2