patients wit bruxism
Conditions
Interventions
Study composed by two groups with 10 participants each: In group MT will be injected botulinum toxin type A (Botox) in the masseter and temporal muscles and in group M will be injected botulinum toxin
Drug
Biological/vaccine
Sponsors
Universidade Ibirapuera
Universidade Ibirapuera
Eligibility
Age
0 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participants of both genders aged 18 to 70 years; participants complaining of clenching, compressing or grinding their teeth for at least 6 months; Masseter and temporal muscle hypertrophy; participants presenting: Headache / chronic orofacial pain, chewing pain, pain on palpation of the chewing and / or facial muscles (middle and lower third of the face).
Exclusion criteria
Exclusion criteria: Participants with BTX-A or albumin allergy; participants have already had botulinum toxin treatment on these muscles for less than 12 months; pregnant or planning to become pregnant or lactating women; participants who are participating in other research involving other drugs; participants taking drugs that interfere with neuromuscular transmission (Aminoglycosides, Anticholinesterases, etc.) or who are taking antibiotics and corticosteroids; participants who are undergoing orthodontic treatment or using a bite plate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reduction of myofacial pain assessed by visual analogue scale (VAS) analysis, being assigned values from 0 to 10 corresponding to pain during longitudinal measurements (15,45,90,120 and 180 days). A greater reduce of myofacial pain is expected in group MT (botulinum toxin application group in both masseter and temporal muscles) when compared to group M (botulinum toxin application only in masseter muscle).These values should decrease in the initial period of 2 to 3 months, with stabilization or increase expected in the following months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The application of Botulinum Toxin A will decrease the chewing force, which will be measured using a gnatodynamometer. Data will be collected before application and longitudinally (15, 45, 90, 120 and 180 days). A greater reduce in strength is expected in group MT (botulinum toxin application group in both masseter and temporal muscles) when compared to group M (botulinum toxin application only in masseter muscle). | — |
Countries
Brazil
Contacts
Public ContactJuliana Ramalho
Universidade Ibirapuera
Outcome results
None listed