Other somatoform disorders, Temporomandibular joint disorders, Bruxism
Conditions
Interventions
The study will be composed of two groups
a control group composed of 15 patients, where serum
physiological and an experimental group with 15 patients, where 20 units of Botulinum Toxin A (Botox)
in each Masséter muscle and 10 Units in each
being one related
with the painful symptomatology of Temporal Mandibular Joint and another related to the quality of
life related to the problem. The factors under study will be randomly distributed b
Drug
Sponsors
Universidade Federal de Uberlândia - UFU
Universidade Federal de Uberlândia - UFU
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Pacients with bruxism.Agree to participate and sign the informed consent form (TCLE)
Exclusion criteria
Exclusion criteria: Existence of active psychosis, another active or cognitive impairment, existence of serious co-morbid conditions, individuals who have had exposure to any botulinum toxin preparation in the last 6 months, participation in another experimental therapeutic protocol, any medical condition in which the administration of the toxin botulinum toxin is contraindicated, including myasthenia gravis, amyotrophic lateral sclerosis and other acute history of dysphagia, history of botulism, a condition or the situation in which the investigators confusion in the subject's ability to participate in the study, inability to understand and sign informed consent, pregnancy, do not meet inclusion criteria and individuals who are hypersensitive to any component of the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The application of Botulinum Toxin A will decrease the chewing force. This evaluation will be done through electromyography of the masseter, bilateral load cells. Data will be collected prior to application, and monthly for 06 months. It is expected to reduce these two parameters in the experimental group, while no reduction in the placebo group. | — |
Secondary
| Measure | Time frame |
|---|---|
| The reduction of myofacial pain in the experimental group is expected, as evidenced by the analysis of the visual analogue scale (VAS), with values ??corresponding from 0 to 10 corresponding to pain during monthly measurements during 6 months. These values ??should decrease in the initial period of 2 to 3 months, being expected stabilization or increase in the following months. | — |
Countries
Brazil
Contacts
Public ContactCristiano;Marcelo Figueiredo;Parreira da Silva
Universidade Federal de Uberlândia - UFU;Universidade Federal de Uberlândia - UFU
Outcome results
None listed