NCT03827122

Botulinum Toxin A Injectable Solution in the Management of Bruxism: A Clinical Trial Study

Botulinum Toxin A Injectable Solution in the Management of Bruxism

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Riyadh Colleges of Dentistry and Pharmacy · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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 age 18-60 years. According to the diagnostic grading system of bruxism all subjects will have an assessment including a bruxism questionnaire (i.e., oral history taking with specific focus on bruxism habits) plus a clinical examination to evaluate bruxism signs and symptoms.

Conditions

• Nocturnal Bruxism

Interventions

Type	Name	Description
DRUG	onabotulinumtoxinA	Experimental group we will use BTX-A administration group. All patients (Male/Female) with bruxism associated with chronic pain in masseter muscles bilaterally Patients will have treatment with 20 units of BOTOX, (Allergan Inc.) per side will be injected at three points into masseter muscle bilaterally.

Timeline

• Start date: 2018-11-13
• Primary completion: 2019-11-11
• Completion: 2019-11-13
• First posted: 2019-02-01
• Last updated: 2019-02-01

Locations

1 site across 1 country: Saudi Arabia

Regulatory

• FDA-regulated drug study