Trial reportOral and maxillofacial surgery2026
Mucoadhesive patch versus benzocaine gel for reducing injection pain: a split-mouth randomized clinical trial.
Trial report in Oral and maxillofacial surgery, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
7 authors.
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Abstract
backgroundMinimizing pain during dental injections is essential for enhancing patient comfort and reducing anxiety-driven treatment avoidance. PURPOSE: To evaluate a novel, engineered bilayer mucoadhesive patch designed to optimize drug bioavailability and reduce injection pain compared to a benzocaine gel. STUDY DESIGN, SETTING, AND SAMPLE: Split-mouth randomized clinical trial at Mashhad University of Medical Sciences involving 36 healthy patients requiring bilateral maxillary dental extractions. PREDICTOR VARIABLE: The primary predictor was the delivery format of the topical anesthetic agent. The novel 20% benzocaine mucoadhesive patch featured a bilayer design: a base layer composed of a chitosan-gelatin-glycerin matrix, and an adhesive layer containing sodium carboxymethylcellulose, gelatin, pectin, 20% benzocaine (ethyl 4-aminobenzoate), and methylene blue. Participants randomly received either 20% benzocaine gel (applied for 30 s) or the 20% benzocaine mucoadhesive patch (applied for 10 min) on buccal and palatal sites of the right or left side. Local anesthesia was administered following a 10-minute washout interval between the left and right sides. MAIN OUTCOME VARIABLE(S): Pain was quantified via the Sound, Eye, Motor (SEM) scale and the 11-point Numeric Rating Scale (NRS-11). COVARIATES: Covariates included age, sex, and baseline anxiety level, assessed via the Beck Anxiety Inventory. ANALYSES: Shapiro-Wilk, Wilcoxon signed-rank, Mann-Whitney U, and Spearman correlation tests (α = 0.05).
resultsNRS-11 scores were significantly lower in the patch group for both buccal and palatal injections (P < 0.05). SEM scores were significantly lower in the patch group at the palatal site (P = 0.011), but not at the buccal site (P = 0.075). Sex, age, and baseline anxiety level were not associated with pain scores. CONCLUSIONS AND RELEVANCE: The 20% benzocaine mucoadhesive patch resulted in lower self-reported pain during both buccal and palatal injections, and lower observer-rated pain during palatal injections, compared to the 20% benzocaine gel.
trial registrationIranian Registry of Clinical Trials (IRCT) IRCT20230125057218N1. Registered on 10 October 2023, https//en.irct.ir/trial/71,206.
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