Evaluation of a polymeric device for local anesthesia: in vivo test for clinical dental procedures in adult humans

• Grant number: 19/18180-1
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: February 01, 2020
• End date: November 30, 2020
• Field of knowledge: Health Sciences - Dentistry - Dental Clinics
• Principal Investigator: Vinícius Pedrazzi
• Grantee: Carolina dos Reis Bertelli
• Host Institution: Faculdade de Odontologia de Ribeirão Preto (FORP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil

Abstract

Local anesthesia corresponds to the reversible blockage of nerve conduction and it determines the loss of pain sensations without altering the level of consciousness. It is of fundamental importance for most dental procedures that usually involve pain. However, its use is one of the main sources of fear on the part of the patient, making the office visit often delayed and even avoided. Based on these assumptions, the objective of this in vivo study will be to evaluate the efficacy of a bioadhesive polymeric device with the fast-dissolve release of anesthetic salts lidocaine and prilocaine, developed for local anesthesia preoperative procedure in dentistry, aiming at reducing or eliminating the use of gingival needles for procedures such as Class I, II, III and V restorations in middle and deep cavities, prosthetic moldings using gingival retractor wires and basic periodontal treatment. The concentrations of anesthetic salts are identical to those of commercially available tubes (15mg for Lidocaine and 15mg for Prilocaine, both hydrochlorides). In the clinical stage, before the application of anesthetic devices, a sensitivity test will be performed with Endo-Frost® on the teeth to be treated for pulp vitality. After the application of the devices, the start of the action (induction time) called T1 (stipulated in 5 min in the pilot works) will be checked and registered. The pain sensitivity will be monitored in real-time and if the patient reports pain or discomfort, the type of ongoing clinical procedure and the time the pain occurred after the onset of anesthesia will be recorded. The study will include 58 patients from the Integrated Clinic, and the need to complement anesthesia with a conventional system (anesthesia with Carpule Syringe and anesthetic tubes) will be evaluated, in which time and in which procedures. According to the results, the variables will be evaluated to verify if they present normal or non-normal distribution to determine the statistical tests.