Study of effect and duration of botox in the treatment of gnash or clench your teeth

Not Applicable

• Conditions: patients wit bruxism; C07.793.099

• Registration Number: RBR-39ght5
• Lead Sponsor: niversidade Ibirapuera

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-21
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).