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Clinical Efficacy and Tolerability of a New Experimental Mucoadhesive Patch for Topical Anesthesia of the Oral Mucosa in Children
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Journal of Clinical Medicine
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Clinical Efficacy and Tolerability of a New Experimental Mucoadhesive Patch for Topical Anesthesia of Oral Mucosa in Pediatric Dentistry
J Clin Med 2024 Mar 08;13(6)1558, GF Ferrazzano, G Di Fabio, S Caruso, R Gatto, V Goyal, S CarusoFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
This clinical trial reports the efficacy and safety of an experimental strategy for administering topical anesthesia to pediatric dental patients prior to an intraoral injection of local anesthesia. This experimental approach maximizes the topical anesthetic efficacy through three mechanisms. First is that the experimental patch uses the eutectic mixture of local anesthetics (EMLA), one of the most effective topical anesthetic formulations used in clinical practice. The concentrations of prilocaine and lidocaine in this formulation of EMLA are higher than most formulations used in dentistry (10% lidocaine and 10% prilocaine rather than 2.5% lidocaine and 2.5% prilocaine). However, higher concentrations of lidocaine and prilocaine increase the concerns for local anesthetic toxicity.1 Additionally, this strategy incorporates a protective mucoadhesive patch, which has been used previously.2 By applying the patch directly onto the dry mucosa, the EMLA formulation is held onto the oral mucosa, blocking dilution by the saliva. One of the most important requirements for effective oral topical anesthesia is that the anesthetic formulation be applied directly onto the dried mucosa. The saliva remaining on the oral tissue acts to block diffusion from the lipid-based topical formulation to the lipid mucosal cell layer. Incorporating these three factors (efficacy of EMLA agents, the concentration of the anesthetics, and the protective patch) appears to be responsible for most of the success reported in this trial.
The results reported in this study appear impressive and may prove to be a valuable addition to a pediatric dentist’s armamentarium. If approved for marketing, the impact of this technology on the dental practice will be dependent on its convenience for the dentists, cost, patient acceptance, and safety. Some toxicology studies will be required to justify the higher concentration of prilocaine and lidocaine used for this EMLA formulation.3,4 Replication of results using randomized allocation will likely be required for regulatory approval. We look forward to reading the progress of developing this potentially useful product.
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