Pain characteristics, psychosocial aspects and salivary level of Calcitonin Gene-Related Peptide (CGRP) in patients with painful temporomandibular disorders and migraine: a controlled clinical trial

• Grant number: 22/13022-1
• Support Opportunities: Scholarships in Brazil - Doctorate
• Start date: August 01, 2023
• End date: December 31, 2025
• Field of knowledge: Health Sciences - Dentistry
• Principal Investigator: Daniela Aparecida de Godoi Gonçalves
• Grantee: Marlon Ferreira Dias
• Host Institution: Faculdade de Odontologia (FOAr). Universidade Estadual Paulista (UNESP). Campus de Araraquara. Araraquara , SP, Brazil

Abstract

Temporomandibular disorder (TMD) is often associated with migraine in terms of comorbidity. Several factors seem to interfere in this association, with emphasis on the involvement of the Trigeminal System and the participation of Calcitonin Gene-Related Peptide (CGRP) in both conditions. Psychosocial factors also seem to interfere with the association. The aim of the present study will be to evaluate the pain characteristics, psychosocial aspects and salivary CGRP level of patients with painful TMD and migraine. For this, a clinical, observational, cross-sectional study will be conducted involving women aged 20 to 50 years. The sample, composed of 80 volunteers, will be stratified into 4 groups: GC: Control Group (volunteers without any painful condition), TMD (volunteers diagnosed with myalgia), MIG: Migraine (participants with episodic migraine), TMD+MIG: TMD and Migraine. To characterize the sample, sociodemographic information will be collected. Assessments of symptoms of depression, anxiety and somatization will be carried out, respectively, through the Patient Health Questionnaire-9 (Patient Health Questionnaire-9, PHQ-9), Generalized Anxiety Disorder-7, GAD-7) and the Patient Health Questionnaire-15 (Patient Health Questionnaire-15, PHQ-15). TMD classification will be performed using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). For the identification of primary headaches, the criteria of the International Classification of Headache Disorders - 3rd Edition (ICHD-3) will be adopted. The pressure pain threshold (PPT) in the trigeminal and extra-trigeminal areas will also be evaluated. The symptoms of central sensitization (CS) will be accessed by the SC inventory (Central Sensitization Inventory - CSI). The analysis of salivary CGRP level will be performed using the ELISA test. Numerical data will be evaluated for normal distribution and the homogeneity of variances of the groups will be compared to apply the most appropriate statistical test. Correlation analysis will be performed to assess the association between salivary CGRP level in patients with Migraine and/or TMD. All statistical analyzes will be performed at a significance level of 5% (± = 0.05). (AU)