Comparison of the effectiveness of botulinum toxin type A in patients with refractory chronic orofacial pain according to different somatosensory profiles

• Grant number: 17/21674-0
• Support Opportunities: Scholarships in Brazil - Post-Doctorate
• Effective date (Start): September 01, 2018
• Effective date (End): December 31, 2021
• Field of knowledge: Health Sciences - Dentistry - Dental Clinics
• Principal Investigator: Paulo César Rodrigues Conti
• Grantee: Giancarlo de La Torre Canales
• Host Institution: Faculdade de Odontologia de Bauru (FOB). Universidade de São Paulo (USP). Bauru , SP, Brazil

Abstract

Chronic orofacial pain is a common and debilitating problem that affects at least 10% of the adult population. This term refers to different disorders that have pain, as the main characteristic, such as Temporomandibular Dysfunction (TMD), neuralgias and neurovascular facial pain. Different multidisciplinary and symptomatic therapies have been proposed to control chronic orofacial pain from these disorders. However, due to the constant reports of new mechanisms that integrate the mechanisms of maintenance of chronic orofacial pain, new therapies are constantly being proposed as injections of Botulinum Toxin type A (BoNT-A). Mechanisms of peripheral and central neuronal hyperexcitability and deficiency in the intrinsic modulatory mechanisms are part of these mechanisms and can be determined by means of tests that determine a patient's somatosensory profile (quantitative sensorial tests (QST)). However, the few randomized and double-blind clinical studies in the literature present contradictory results regarding the efficacy of BoNT-A for these disorders; due mainly to the lack of consistent evidence on which specific mechanisms of chronic pain or which somatosensory profiles the botulinum toxin would be most effective. Thus, the present double-blind, randomized clinical trial aims to determine the influence and efficacy of botulinum toxin tipa A on the modulation and perception of pain in the orofacial region in patients refractory to conventional therapies. To this end, 80 adult participants, aged 18-50 years, with musculoskeletal pain and / or neuropathic pain, who have been treated with conservative therapies without success in the last 3 months, will be selected. Participants will be classified according to the somatosensory profile presented after receiving injections of botulinum toxin or saline according to the randomization performed. The somatosensory characteristics related to pain perception and pain modulation will be assessed in the anterior temporal region, masseter and tenar by the mechanical pain threshold (MPT), temporal summation test (WUR), threshold (PPT), thermal pain threshold (TSL), and pain modulation conditioning test (CPM), respectively. The psychosocial characteristics qualified by the Catastrophic Thoughts Scale Questionnaire, Pittsburg Sleep Quality Index, SF-36 generic quality of life assessment questionnaire, and Global Change Perception Scale (PGICS) will also be evaluated. Data will be submitted to statistical analysis using multivariate analysis of variance (ANOVA) and multiple linear regression, with significance level of 95%.

Scientific publications

(8)

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

POLUHA, RODRIGO LORENZI; TORRE CANALES, GIANCARLO DE LA; BONJARDIM, LEONARDO RIGOLDI; RODRIGUES CONTI, PAULO CESAR. Somatosensory and psychosocial profile of patients with painful temporomandibular joint clicking. Journal of Oral Rehabilitation, v. 47, n. 11, SEP 2020. (17/21674-0)

CANALES, GIANCARLO DE LA TORRE; CAMARA-SOUZA, MARIANA BARBOSA; POLUHA, RODRIGO LORENZI; GRILLO, CASSIA MARIA; RODRIGUES CONTI, PAULO CESAR; ROSARIO DE SOUSA, MARIA DA LUZ; MATHEUS RODRIGUES GARCIA, RENATA CUNHA; RIZZATTI-BARBOSA, CELIA MARISA. Botulinum toxin type A and acupuncture for masticatory myofascial pain: a randomized clinical trial. Journal of Applied Oral Science, v. 29, 2021. (14/15863-7, 17/21674-0, 17/23429-3)

GARCIA DUTRA DE CASTRO; ALFONSO SÁNCHEZ-AYALA; GIANCARLO DE LA TORRE CANALES; OLÍVIA MARIA COSTA FIGUEREDO; MARIANA BARBOSA CÂMARA-SOUZA; CAMILLA FRAGA DO AMARAL; RENATA CUNHA MATHEUS RODRIGUES GARCIA. Effect of frozen storage on preservation of a silicone-based test food material. Braz. J. Oral Sci., v. 21, 2022-04-15. (17/21674-0, 17/23429-3)

POLUHA, RODRIGO LORENZI; DE LA TORRE CANALES, GIANCARLO; BONJARDIM, LEONARDO RIGOLDI; CONTI, PAULO CESAR RODRIGUES. Clinical variables associated with the presence of articular pain in patients with temporomandibular joint clicking. CLINICAL ORAL INVESTIGATIONS, v. 25, n. 6, NOV 2020. (17/21674-0)

CANALES, GIANCARLO DE LA TORRE; BONJARDIM, LEONARDO RIGOLDI; POLUHA, RODRIGO LORENZI; CARVALHO SOARES, FLAVIA FONSECA; GUARDA-NARDINI, LUCA; CONTI, PAULO RODRIGUES; MANFREDINI, DANIELE. Correlation Between Physical and Psychosocial Findings in a Population of Temporomandibular Disorder Patients. International Journal of Prosthodontics, v. 33, n. 2, p. 155-159, MAR-APR 2020. (17/21674-0)

CANALES, GIANCARLO DE LA TORRE; POLUHA, RODRIGO LORENZI; LORA, VICTOR MUNOZ; ARAUJO OLIVEIRA FERREIRA, DYNA MARA; STUGINSKI-BARBOSA, JULIANA; BONJARDIM, LEONARDO RIGOLDI; DEL BEL CURY, ALTAIR ANTONINHA; RODRIGUES CONTI, PAULO CESAR. Botulinum toxin type A applications for masticatory myofascial pain and trigeminal neuralgia: what is the evidence regarding adverse effects?. CLINICAL ORAL INVESTIGATIONS, v. 23, n. 9, p. 3411-3421, SEP 2019. (17/21674-0)

POLUHA, RODRIGO LORENZI; CANALES, GIANCARLO DE LA TORRE; BONJARDIM, LEONARDO RIGOLDI; RODRIGUES CONTI, PAULO CESAR. Can Concomitant Masticatory Muscle Contraction Interfere with Temporomandibular Joint Arthralgia Evaluation?. JOURNAL OF ORAL & FACIAL PAIN AND HEADACHE, v. 35, n. 1, p. 72-76, WIN 2021. (17/21674-0)

RODRIGO LORENZI POLUHA; GIANCARLO DE LA TORRE CANALES; LEONARDO RIGOLDI BONJARDIM; PAULO CÉSAR RODRIGUES CONTI. Oral behaviors, bruxism, malocclusion and painful temporomandibular joint clicking: is there an association?. Brazilian Oral Research, v. 35, 2021-08-06. (17/21674-0)