---
title: "Mucoadhesive Patch vs Benzocaine Gel for Reducing Dental Injection Pain: Split-Mouth RCT"
id: "pubmed-42625076"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42625076"
content_type: "clinical_feed_article"
specialty: "Dentistry"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42625076/"
doi: "10.1007/s10006-026-01615-8"
published_at: "2026-08-21T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Mucoadhesive Patch vs Benzocaine Gel for Reducing Dental Injection Pain: Split-Mouth RCT
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42625076
- **Specialty:** [Dentistry](https://medichelpline.com/clinical-feed/dentistry.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42625076/)
- **DOI:** [10.1007/s10006-026-01615-8](https://doi.org/10.1007%2Fs10006-026-01615-8)
- **Published At:** 2026-08-21T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This split-mouth randomized clinical trial compared a novel **20% benzocaine mucoadhesive patch** with a standard 20% benzocaine gel for reducing pain from maxillary dental injections. - The study enrolled 36 healthy patients undergoing bilateral maxillary tooth extractions at Mashhad University of Medical Sciences. - The mucoadhesive patch had a bilayer design: a chitosan–gelatin–glycerin base layer and an adhesive layer containing sodium carboxymethylcellulose, gelatin, pectin, 20% benzocaine, and methylene blue. - Interventions: benzocaine gel applied for 30 seconds versus the mucoadhesive patch applied for 10 minutes at buccal and palatal sites; a 10-minute washout interval separated left and right side anesthetic procedures. - Pain outcomes were recorded using the observer-rated **SEM** (Sound, Eye, Motor) scale and patient-reported **NRS-11** (11-point Numeric Rating Scale). - Statistical tests included Shapiro–Wilk, Wilcoxon signed-rank, Mann–Whitney U, and Spearman correlation with α = 0.05. - Results: NRS-11 scores were significantly lower with the patch for both buccal and palatal injections (P < 0.05). SEM scores were significantly lower with the patch at the palatal site (P = 0.011) but not at the buccal site (P = 0.075). - Sex, age, and baseline anxiety (Beck Anxiety Inventory) did not correlate with pain scores. - The authors conclude the **20% benzocaine mucoadhesive patch** reduced self-reported pain for buccal and palatal injections and observer-rated pain for palatal injections versus benzocaine gel. - Trial registration: Iranian Registry of Clinical Trials IRCT20230125057218N1 (registered 10 October 2023).
## Clinical Analysis & Structured Key Points
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Hoseinzadehmel@gmail.com.") Affiliations Expand ### Affiliations * 1 Department of Pediatric Dentistry, School of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran. * 2 Student Research Committee, Dental School, Mashhad University of Medical Sciences, Mashhad, Iran. * 3 Dental Materials Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. * 4 Oral and Maxillofacial Surgery Department, Dental School, Mashhad University of Medical Sciences, Mashhad, Iran. * 5 Department of Pediatric Dentistry, Faculty of Dentistry, Arak University of Medical Sciences, Arak, Iran. * 6 Dental Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Hoseinzadehmel@gmail.com. * PMID: **42625076** * DOI: [ 10.1007/s10006-026-01615-8 ](https://doi.org/10.1007/s10006-026-01615-8) Item in Clipboard Randomized Controlled Trial # Mucoadhesive patch versus benzocaine gel for reducing injection pain: a split-mouth randomized clinical trial Rasoul Sahebalam et al. Oral Maxillofac Surg. 2026. Show details Display options Display options Format Abstract PubMed PMID Oral Maxillofac Surg Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Oral+Maxillofac+Surg%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Oral+Maxillofac+Surg%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42625076/) . 2026 Aug 21;30(1):137. doi: 10.1007/s10006-026-01615-8. ### Authors [Rasoul Sahebalam](https://pubmed.ncbi.nlm.nih.gov/?term=Sahebalam+R&cauthor_id=42625076)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42625076/#short-view-affiliation-1 "Department of Pediatric Dentistry, School of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran."), [Azarnoosh Sheibani](https://pubmed.ncbi.nlm.nih.gov/?term=Sheibani+A&cauthor_id=42625076)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42625076/#short-view-affiliation-2 "Student Research Committee, Dental School, Mashhad University of Medical Sciences, Mashhad, Iran."), [Hossein Bagheri](https://pubmed.ncbi.nlm.nih.gov/?term=Bagheri+H&cauthor_id=42625076)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42625076/#short-view-affiliation-3 "Dental Materials Research Center, Mashhad University of Medical Sciences, Mashhad, Iran."), [Majid Eshghpour](https://pubmed.ncbi.nlm.nih.gov/?term=Eshghpour+M&cauthor_id=42625076)[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42625076/#short-view-affiliation-4 "Oral and Maxillofacial Surgery Department, Dental School, Mashhad University of Medical Sciences, Mashhad, Iran."), [Ehsan Zahabi](https://pubmed.ncbi.nlm.nih.gov/?term=Zahabi+E&cauthor_id=42625076)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42625076/#short-view-affiliation-3 "Dental Materials Research Center, Mashhad University of Medical Sciences, Mashhad, Iran."), [Nikoo Rajabi](https://pubmed.ncbi.nlm.nih.gov/?term=Rajabi+N&cauthor_id=42625076)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42625076/#short-view-affiliation-5 "Department of Pediatric Dentistry, Faculty of Dentistry, Arak University of Medical Sciences, Arak, Iran."), [Melika Hoseinzadeh](https://pubmed.ncbi.nlm.nih.gov/?term=Hoseinzadeh+M&cauthor_id=42625076)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42625076/#short-view-affiliation-6 "Dental Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Hoseinzadehmel@gmail.com.") ### Affiliations * 1 Department of Pediatric Dentistry, School of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran. * 2 Student Research Committee, Dental School, Mashhad University of Medical Sciences, Mashhad, Iran. * 3 Dental Materials Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. * 4 Oral and Maxillofacial Surgery Department, Dental School, Mashhad University of Medical Sciences, Mashhad, Iran. * 5 Department of Pediatric Dentistry, Faculty of Dentistry, Arak University of Medical Sciences, Arak, Iran. * 6 Dental Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Hoseinzadehmel@gmail.com. * PMID: **42625076** * DOI: [ 10.1007/s10006-026-01615-8 ](https://doi.org/10.1007/s10006-026-01615-8) Item in Clipboard Cite Display options Display options Format Abstract PubMed PMID ## Abstract **Background:** Minimizing 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). **Results:** NRS-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 registration:** Iranian Registry of Clinical Trials (IRCT) IRCT20230125057218N1. Registered on 10 October 2023, https//en.irct.ir/trial/71,206. **Keywords:** Benzocaine; Local anesthetics; Pain measurement; Tooth extraction; Topical administration. © 2026. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Conflict of interest statement Declarations. Ethical approval and consent to participate: This study adhered to the principles of the Declaration of Helsinki. All methods were conducted in accordance with relevant guidelines and regulations. This RCT was conducted after obtaining ethical approval from the Research Ethics Committee of the Faculty of Dentistry, Mashhad University of Medical Sciences (IR.MUMS.DENTISTRY.REC.1402.003) and registration with the Iranian Registry of Clinical Trials (IRCT20230125057218N1) on 10 October 2023. This RCT was reported in accordance with the CONSORT guidelines. Written informed consent was obtained from all participants or their legal guardians. Competing interests: The authors declare no competing interests. ## Similar articles * [ Comparison of topical EMLA 5% oral adhesive to benzocaine 20% on the pain experienced during palatal anesthetic infiltration in children. ](https://pubmed.ncbi.nlm.nih.gov/11242723/) Primosch RE, Rolland-Asensi G.Primosch RE, et al.Pediatr Dent. 2001 Jan-Feb;23(1):11-4.Pediatr Dent. 2001.PMID: 11242723Clinical Trial. * [ Comparison of topical anesthetics (EMLA/Oraqix vs. benzocaine) on pain experienced during palatal needle injection. ](https://pubmed.ncbi.nlm.nih.gov/17331753/) Al-Melh MA, Andersson L.Al-Melh MA, et al.Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 May;103(5):e16-20. doi: 10.1016/j.tripleo.2006.11.033. Epub 2007 Feb 27.Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007.PMID: 17331753Clinical Trial. * [ Clinical Comparison: Fast-Acting and Traditional Topical Dental Anesthetic. ](https://pubmed.ncbi.nlm.nih.gov/27269661/) DiMarco AC, Wetmore AO.DiMarco AC, et al.Anesth Prog. 2016 Summer;63(2):55-61. doi: 10.2344/0003-3006-63.2.55.Anesth Prog. 2016.PMID: 27269661Free PMC article.Clinical Trial. * [ Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas. ](https://pubmed.ncbi.nlm.nih.gov/36321557/) Crider K, Williams J, Qi YP, Gutman J, Yeung L, Mai C, Finkelstain J, Mehta S, Pons-Duran C, Menéndez C, Moraleda C, Rogers L, Daniels K, Green P.Crider K, et al.Cochrane Database Syst Rev. 2022 Feb 1;2(2022):CD014217. doi: 10.1002/14651858.CD014217.Cochrane Database Syst Rev. 2022.Update in: [Cochrane Database Syst Rev. 2026 Feb 18;2:CD014217. doi: 10.1002/14651858.CD014217.pub2.](https://pubmed.ncbi.nlm.nih.gov/41705996/)PMID: 36321557Free PMC article.Updated. * [ Effectiveness and tolerability of pharmacologic and combined interventions for reducing injection pain during routine childhood immunizations: systematic review and meta-analyses. ](https://pubmed.ncbi.nlm.nih.gov/19781433/) Shah V, Taddio A, Rieder MJ; HELPinKIDS Team.Shah V, et al.Clin Ther. 2009;31 Suppl 2:S104-51. doi: 10.1016/j.clinthera.2009.08.001.Clin Ther. 2009.PMID: 19781433 [ See all similar articles ](https://pubmed.ncbi.nlm.nih.gov/?linkname=pubmed_pubmed&from_uid=42625076) ## References 1. 1. Ibrahim HA, Abdelrahman AM (2021) Effectiveness Of Benzocaine Gelpatch In Reducing Palatal Injection Pain In Pediatric Dental Patients: A Split-Mouth Randomized Clinical Trial. Alex Dent J 46(1):173–178 2. 1. Chauca-Bajaña L, Pérez-Jardón A, Carpio-Cevallos C, Ordoñez Balladares A, Proaño-Yela P, Velásquez Ron B et al (2025) Factors associated with dental anxiety in patients treated at an integrated dental clinic: a cross-sectional study. Front Oral Health 6:1689805 - [DOI](https://doi.org/10.3389/froh.2025.1689805) - [PubMed](https://pubmed.ncbi.nlm.nih.gov/41080813/) - [PMC](https://pmc.ncbi.nlm.nih.gov/articles/12507877/) 3. 1. Aldooma MY, Mohamed Ali EA (2025) Effect of anxiety on pain perception during infiltration anesthesia of maxillary teeth in a group of adult Sudanese patients at Khartoum Teaching Dental Hospital. Cureus 17(10):e93988 - [PubMed](https://pubmed.ncbi.nlm.nih.gov/41209944/) - [PMC](https://pmc.ncbi.nlm.nih.gov/articles/12589850/) 4. 1. Sanglard LF, da Silva Paiva L, Rego ICQ, Barollo AV, Feletti MP, Silva DN et al (2025) Topical anesthetics methods used to reduce needle pain/discomfort prior to local anesthesia in children and adolescents: a scoping review. Evid Based Dent 26(1):65 - [DOI](https://doi.org/10.1038/s41432-025-01106-x) - [PubMed](https://pubmed.ncbi.nlm.nih.gov/39856200/) 5. 1. Kreider KA, Stratmann RG, Milano M, Agostini FG, Munsell M (2001) Reducing children’s injection pain: lidocaine patches versus topical benzocaine gel. Pediatr Dent 23(1):19–23 - [PubMed](https://pubmed.ncbi.nlm.nih.gov/11242725/) Show all 31 references ## Publication types * Randomized Controlled Trial Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Randomized+Controlled+Trial%22%5Bpt%5D&sort=date&sort_order=desc) * [ Search in MeSH ](https://www.ncbi.nlm.nih.gov/mesh?term=Randomized+Controlled+Trial) * [ Add to Search ](https://pubmed
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