Status:
UNKNOWN
Botulinum Toxin A Injectable Solution in the Management of Bruxism: A Clinical Trial Study
Lead Sponsor:
Riyadh Colleges of Dentistry and Pharmacy
Conditions:
Nocturnal Bruxism
Eligibility:
All Genders
20-60 years
Phase:
PHASE2
Brief Summary
A Clinical Trial Study to investigate the potential performance of BTXA on masseter muscle on patient with nocturnal bruxism and to check the pain scale and share this clinical experience.
Detailed Description
Experimental group we will use BTX-A administration group. All patients (Male/Female) with bruxism associated with chronic pain in masseter muscles bilaterally participated in this study. The patients...
Eligibility Criteria
Inclusion
- Moderate to severe pain in relation to the masseter muscles and TMJ area related to bruxism during clinical examination.
- Aged 20-60 patients.
- Tooth-grinding sounds corroborated by family members or caregivers.
- Cases where bruxism resulted in occlusal surface attrition of posterior teeth
Exclusion
- pain in the orofacial region,
- insomnia,
- known botulinum toxin allergy,
- pregnancy,
- neuromuscular disease,
- bleeding disorders,
- antibiotic therapy,
- pulmonary disease that produced coughing during sleep,
- infectious skin lesion at the site of the injection.
Key Trial Info
Start Date :
November 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 13 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03827122
Start Date
November 13 2018
End Date
November 13 2019
Last Update
February 1 2019
Active Locations (1)
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1
Riyadh Elm University
Riyadh, Saudi Arabia, 11681