Evaluation of the association of Amitriptyline or Acmella Oleracea with Lidocaine and Prilocaine nanocapsules in topical anesthesia: randomized and crossover clinical trial

• Grant number: 23/15414-7
• Support Opportunities: Scholarships in Brazil - Master
• Start date: September 01, 2024
• End date: May 31, 2025
• Field of knowledge: Health Sciences - Dentistry - Dental Clinics
• Principal Investigator: Camila Batista da Silva de Araujo Candido
• Grantee: Michael Henrique Araújo Monteiro
• Host Institution: Faculdade de Odontologia de Piracicaba (FOP). Universidade Estadual de Campinas (UNICAMP). Piracicaba , SP, Brazil

Abstract

INTRODUCTION: In dentistry, pain is a frequent challenge, and topical anesthetics, such as lidocaine (LDC) and prilocaine (PLC) in 5% cream, are used to relieve pain during puncture. However, inefficient superficial anesthesia leads to the search for alternatives, such as amitriptyline and spilanthol, which, when combined with nanotechnology, may improve the effectiveness and safety of treatments. OBJECTIVE: To compare the anesthetic efficacy of topical treatments, with and without nanoencapsulation, in vestibular and palatal topical anesthesia of upper premolars, through pulp response and puncture sensitivity. METHODOLOGY: Participants will be 36 undergraduate and graduate students from FOP-UNICAMP, of both sexes, aged between 18 and 30 years. The study will be crossover, blind, and with randomized application order, in three sessions, with a one-week interval between them, applying the following topical formulas: G1. EMLA (LDC 2.5% and PLC 2.5%); G2. LDC 2.5%, PLC 2.5%, and amitriptyline 5%; G3. LDC 2.5%, PLC 2.5%, and 20% Acmella oleracea extract (7.5% spilanthol); G4. LDC 2.5%, PLC 2.5%, and amitriptyline 5% nanocapsules in topical base; G5. LDC 2.5%, PLC 2.5% nanocapsules in topical base with 20% Acmella oleracea extract (7.5% spilanthol); G6. Topical base without active ingredients as placebo. Puncture pain will be assessed using the Visual Analog Scale (VAS) questionnaire after application, while pulp sensitivity will be tested with the Pulp Tester (PTE). Results will be statistically analyzed with ANOVA, Tukey's test, and Friedman's test, considering significant differences with p <0.05.