Clinical evaluation of a noninvasive polymeric device developed for local anesthesia

• Grant number: 13/15048-9
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: April 01, 2014
• End date: March 31, 2015
• Field of knowledge: Health Sciences - Dentistry - Dental Clinics
• Principal Investigator: Vinícius Pedrazzi
• Grantee: Alex Rodrigues Ribeiro
• Host Institution: Faculdade de Odontologia de Ribeirão Preto (FORP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil

Abstract

The objective of this study is to evaluate the clinical effectiveness of a cellulosic polymer device having anesthetic salts as active ingredients in the prevention of pain in pre - clinical and operative procedures in dentistry, decreasing or eliminating the use of needles in gingival infiltrative anesthesia. Three devices with bioadhesive property developed for the modified drug release in contact with oral mucosa will be tested: placebo (A); a core containing the anesthetic salt prilocaine (B); one containing the two other anesthetics salts prilocaine + lidocaine (C) in paired tests, after drying of the mucosa and placement of devices with sterile instrument in the region of the first upper premolars, corresponding to the fornix of the vestibule. The release of the active ingredients will occur at fast-dissolving process. 21 volunteers of both genders, healthy, aged between 18 and 30 will be selected for a randomized, controlled, triple-blind and crossover clinical trial. Pre and post application symptoms tests will be performed with the use of the electronic probe Florida Probe® System (Florida Probe Corporation, Gainesville, FL, USA), applied in the perpendicular direction to the mucosal tissue, simulating the use of gingival needle and with constant pressure of 25 grams for evaluating dental-periodontal tissue sensitivity. It will be supplemented by thermic test using the Roeko Endo-Frost® refrigerant spray (propane/butane/isobutane gas mixture stored in a pressurised can) for evaluation of pulp sensitivity. To measure pain present / absent symptoms visual analogue scale (VAS) and McGill Pain Questionnaire in Portuguese version will be used. Individuals will receive instructions on how to respond to questionnaires measuring pain stimuli, which would be counted immediately after the response. With the data obtained from the tests, analysis of variance and appropriate statistical test will be performed.