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...
Main Authors: | , , , , , |
---|---|
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 |