Clinical Efficacy and Tolerability of a New Experimental Mucoadhesive Patch for Topical Anesthesia of Oral Mucosa in Pediatric Dentistry

<b>Background</b>: The injection of local anesthetics is the procedure that still causes the most fear and anxiety in a dental session; to minimize this problem, we can use topical anesthesia. The aim of this study is to analyze the tolerability and the clinical efficacy in the control o...

Full description

Bibliographic Details
Main Authors: Gianmaria Fabrizio Ferrazzano, Giuseppe Di Fabio, Sara Caruso, Roberto Gatto, Varinder Goyal, Silvia Caruso
Format: Article
Language:English
Published: MDPI AG 2024-03-01
Series:Journal of Clinical Medicine
Subjects:
Online Access:https://www.mdpi.com/2077-0383/13/6/1558
_version_ 1797240587124998144
author Gianmaria Fabrizio Ferrazzano
Giuseppe Di Fabio
Sara Caruso
Roberto Gatto
Varinder Goyal
Silvia Caruso
author_facet Gianmaria Fabrizio Ferrazzano
Giuseppe Di Fabio
Sara Caruso
Roberto Gatto
Varinder Goyal
Silvia Caruso
author_sort Gianmaria Fabrizio Ferrazzano
collection DOAJ
description <b>Background</b>: The injection of local anesthetics is the procedure that still causes the most fear and anxiety in a dental session; to minimize this problem, we can use topical anesthesia. The aim of this study is to analyze the tolerability and the clinical efficacy in the control of pain, during the subsequent injection of the local anesthetic, of an experimental anesthetic patch with a new formulation, which was previously tested in gel formula. <b>Methods</b>: A total of 150 children, aged 4 to 9 years, were included in the study. Each patient was treated using three different pre-anesthesia methods (placebo gel, experimental gel, and experimental patch), according to a split-mouth procedure, within a week of each other. The injection pain was analyzed using the WBFPRS and FLACC scales. Patients’ caregivers’ satisfaction was recorded at the end of the procedures. The data were analyzed using one-way ANOVA-RM, Wilcoxon–Mann–Whitney, Mann–Whitney U, and χ<sup>2</sup> tests. <b>Results</b>: In this study, significantly higher pain ratings were observed with the topical placebo gel and lower pain ratings were observed with the experimental patch. <b>Conclusion</b>: The use of the patch proved to be very effective in reducing pain both subjectively and objectively, in the absence of both local and systemic side effects, validating its use in the oral mucosa.
first_indexed 2024-04-24T18:09:48Z
format Article
id doaj.art-fd24bdea66f54a50ae280cf619bcfdb4
institution Directory Open Access Journal
issn 2077-0383
language English
last_indexed 2024-04-24T18:09:48Z
publishDate 2024-03-01
publisher MDPI AG
record_format Article
series Journal of Clinical Medicine
spelling doaj.art-fd24bdea66f54a50ae280cf619bcfdb42024-03-27T13:47:42ZengMDPI AGJournal of Clinical Medicine2077-03832024-03-01136155810.3390/jcm13061558Clinical Efficacy and Tolerability of a New Experimental Mucoadhesive Patch for Topical Anesthesia of Oral Mucosa in Pediatric DentistryGianmaria Fabrizio Ferrazzano0Giuseppe Di Fabio1Sara Caruso2Roberto Gatto3Varinder Goyal4Silvia Caruso5UNESCO Chair in Health Education and Sustainable Development, Paediatric Dentistry Section, University of Naples “Federico II”, 80138 Naples, ItalyDepartment of Life, Health and Environmental Sciences, Paediatric Dentistry, University of L’Aquila, 67100 L’Aquila, ItalyDepartment of Life, Health and Environmental Sciences, Paediatric Dentistry, University of L’Aquila, 67100 L’Aquila, ItalyDepartment of Life, Health and Environmental Sciences, Paediatric Dentistry, University of L’Aquila, 67100 L’Aquila, ItalyDepartment of Paediatric & Preventive Dentistry, Guru Nanak Dev Dental College & Research Institute, Sunam 148028, Punjab, IndiaDepartment of Life, Health and Environmental Sciences, Paediatric Dentistry, University of L’Aquila, 67100 L’Aquila, Italy<b>Background</b>: The injection of local anesthetics is the procedure that still causes the most fear and anxiety in a dental session; to minimize this problem, we can use topical anesthesia. The aim of this study is to analyze the tolerability and the clinical efficacy in the control of pain, during the subsequent injection of the local anesthetic, of an experimental anesthetic patch with a new formulation, which was previously tested in gel formula. <b>Methods</b>: A total of 150 children, aged 4 to 9 years, were included in the study. Each patient was treated using three different pre-anesthesia methods (placebo gel, experimental gel, and experimental patch), according to a split-mouth procedure, within a week of each other. The injection pain was analyzed using the WBFPRS and FLACC scales. Patients’ caregivers’ satisfaction was recorded at the end of the procedures. The data were analyzed using one-way ANOVA-RM, Wilcoxon–Mann–Whitney, Mann–Whitney U, and χ<sup>2</sup> tests. <b>Results</b>: In this study, significantly higher pain ratings were observed with the topical placebo gel and lower pain ratings were observed with the experimental patch. <b>Conclusion</b>: The use of the patch proved to be very effective in reducing pain both subjectively and objectively, in the absence of both local and systemic side effects, validating its use in the oral mucosa.https://www.mdpi.com/2077-0383/13/6/1558dental injectionlidocainepain managementpediatric dentistryprilocainetopical anesthetic
spellingShingle Gianmaria Fabrizio Ferrazzano
Giuseppe Di Fabio
Sara Caruso
Roberto Gatto
Varinder Goyal
Silvia Caruso
Clinical Efficacy and Tolerability of a New Experimental Mucoadhesive Patch for Topical Anesthesia of Oral Mucosa in Pediatric Dentistry
Journal of Clinical Medicine
dental injection
lidocaine
pain management
pediatric dentistry
prilocaine
topical anesthetic
title Clinical Efficacy and Tolerability of a New Experimental Mucoadhesive Patch for Topical Anesthesia of Oral Mucosa in Pediatric Dentistry
title_full Clinical Efficacy and Tolerability of a New Experimental Mucoadhesive Patch for Topical Anesthesia of Oral Mucosa in Pediatric Dentistry
title_fullStr Clinical Efficacy and Tolerability of a New Experimental Mucoadhesive Patch for Topical Anesthesia of Oral Mucosa in Pediatric Dentistry
title_full_unstemmed Clinical Efficacy and Tolerability of a New Experimental Mucoadhesive Patch for Topical Anesthesia of Oral Mucosa in Pediatric Dentistry
title_short Clinical Efficacy and Tolerability of a New Experimental Mucoadhesive Patch for Topical Anesthesia of Oral Mucosa in Pediatric Dentistry
title_sort clinical efficacy and tolerability of a new experimental mucoadhesive patch for topical anesthesia of oral mucosa in pediatric dentistry
topic dental injection
lidocaine
pain management
pediatric dentistry
prilocaine
topical anesthetic
url https://www.mdpi.com/2077-0383/13/6/1558
work_keys_str_mv AT gianmariafabrizioferrazzano clinicalefficacyandtolerabilityofanewexperimentalmucoadhesivepatchfortopicalanesthesiaoforalmucosainpediatricdentistry
AT giuseppedifabio clinicalefficacyandtolerabilityofanewexperimentalmucoadhesivepatchfortopicalanesthesiaoforalmucosainpediatricdentistry
AT saracaruso clinicalefficacyandtolerabilityofanewexperimentalmucoadhesivepatchfortopicalanesthesiaoforalmucosainpediatricdentistry
AT robertogatto clinicalefficacyandtolerabilityofanewexperimentalmucoadhesivepatchfortopicalanesthesiaoforalmucosainpediatricdentistry
AT varindergoyal clinicalefficacyandtolerabilityofanewexperimentalmucoadhesivepatchfortopicalanesthesiaoforalmucosainpediatricdentistry
AT silviacaruso clinicalefficacyandtolerabilityofanewexperimentalmucoadhesivepatchfortopicalanesthesiaoforalmucosainpediatricdentistry