Evaluation of pain after topical application of microneedles at the oral cavity of healthy volunteers

• Grant number: 16/24057-0
• Support Opportunities: Scholarships in Brazil - Master
• Start date: March 01, 2017
• End date: March 31, 2019
• Field of knowledge: Health Sciences - Dentistry - Dental Clinics
• Agreement: Coordination of Improvement of Higher Education Personnel (CAPES)
• Principal Investigator: Michelle Franz Montan Braga Leite
• Grantee: Stephany di Carla Santos
• Host Institution: Faculdade de Odontologia de Piracicaba (FOP). Universidade Estadual de Campinas (UNICAMP). Piracicaba , SP, Brazil
• Associated research grant: 12/06974-4 - Development, biocompatibility and permeation studies on gel formulations of poly-epsilon-caprolactone nanocapsules containing local anesthetics, AP.JP

Abstract

Recent studies have proposed the use of microneedles as a promising transdermal drug delivery device for either topical anesthesia or systemic delivery. Microneedles have been extensively studied as allow painless and minimally invasive application at the human skin, and enable successful systemic delivery. Due to poor permeability of the oral mucosa, this technology can be useful for delivery of different topically applied drugs and vaccines. In special, microneedles could improve anesthetic efficacy of topical anesthetics and other drugs in Dentistry, however, these devices have not yet been evaluated in human oral mucosa. Therefore, the objective of the present study is to evaluate pain caused by insertion of microneedles in different sites of oral cavity. In this crossover, randomized, double blinded clinical trial, 40 volunteers will be submitted to topical application of microneedles in different regions of oral mucosa (palate, buccal mucosa, gingiva, tongue and inner lip) and pain during the insertion will be evaluated in a visual analog scale (VAS). We hypothesize that the application of microneedles at the oral mucosa can promote little or no pain, and can be a reliable method for delivery of different drugs used in dentistry such as local anesthetics, anti-inflammatory drugs, antibiotics, antifungal, among others. (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

SANTOS, STEPHANY DI CARLA; FAVARO-MOREIRA, NADIA CRISTINA; ABDALLA, HENRIQUE BALLASSIN; XAVIER AUGUSTO, GABRIELA GAMA; COSTA, YURI MARTINS; VOLPATO, MARIA CRISTINA; GROPPO, FRANCISCO CARLOS; GILL, HARVINDER SINGH; FRANZ-MONTAN, MICHELLE. A crossover clinical study to evaluate pain intensity from microneedle insertion in different parts of the oral cavity. International Journal of Pharmaceutics, v. 592, JAN 5 2021. (16/24057-0, 12/06974-4, 15/50004-8)

Academic Publications

(References retrieved automatically from State of São Paulo Research Institutions)

SANTOS, Stephany di Carla. Pain and safety of microneedle application in the oral cavity of human volunteers. 2019. Master's Dissertation - Universidade Estadual de Campinas (UNICAMP). Faculdade de Odontologia de Piracicaba Piracicaba, SP.