Inter-rater reliability of the evaluation of dental topical anesthetics toxicity by chicken embryo chorioallantoic membrane model.

• Grant number: 23/00341-4
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: April 01, 2023
• End date: February 29, 2024
• Field of knowledge: Health Sciences - Dentistry
• Principal Investigator: Michelle Franz Montan Braga Leite
• Grantee: Laura Campos Dutra de Moraes
• Host Institution: Faculdade de Odontologia de Piracicaba (FOP). Universidade Estadual de Campinas (UNICAMP). Piracicaba , SP, Brazil

Abstract

New therapeutic formulations must be tested for safety and efficacy. One of the essential steps is in vivo toxicity testing. In the case of products created for topical use in the oral cavity, the test considered the gold standard is called the "Oral Mucosa Irritation Test", performed in hamsters. For causing discomfort, pain and suffering in the animal some alternative methodologies are gaining prominence, such as the investigation of the toxicity of chemicals in chorioallantoic membrane (CAM) of the chicken embryo. This model is considered of easy access, low cost, and meets the principles of the 3Rs. The evaluation is done by applying the test formulation on the CAM and then analyzing the possible toxic effects, such as: hemorrhage, vessel lysis and coagulation. The formulations are classified through visual analysis by one or more evaluators, when it is done from two or more examiners it is essential to analyze the reliability between the evaluated data depending on the judgment of the evaluators. Therefore, the objective of this study is to evaluate the inter-examiner reliability between the visual analyses of the toxicity effects of topical dental and commercial anesthetic formulations using the chicken embryo chorioallantoic membrane method. The formulations will be tested and evaluated by two examiners, and then classified as to their toxicity. The relative inter-examiner reliability of the final values used for substance classification will be estimated using the intraclass correlation coefficient (ICC) and its 95% confidence interval (CI). Non-overlapping 95% CIs will be considered significantly different. Absolute reliability (agreement) will be estimated using the standard error of measurement (SEM). Finally, the inter-examiner reliability considering the final classification of the substance according to the classification categories will be done by means of the Kappa agreement coefficient.