Evaluation of BTX Injections in Treatment of Bruxism

Sponsor
Alexandria University
Study ID
NCT05980559
Phase
PHASE3
Status
Unknown

Conditions

  • Bruxism

Eligibility Criteria

Sex
ALL
Age
20 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Xeomin — DRUG
    50 units of Incobotulinumtoxin A (BTX A) Xeomin® Injections into the masseter and temporalis muscles bilaterally (15 Units per muscle applied with 2 injections in each masseter muscle) (10 Units per muscle applied with 2 injections in each temporalis muscle)

Study Details

Aim of this study is to evaluate the effect of botulinum toxin type A (Xeomin®) on patients complaining from bruxism. The study will be a one arm clinical trial. Twelve subjects reporting bruxism irresponsive to conventional treatment modalities will be recruited and will be injected with botulinum toxin A (Xeomin®) in both masseter and temporalis muscles. Pain levels, Electromyographic activity and maximum occlusal force will be recorded in the subjects before injection and at 1 and 3 months after injection to determine the effect of treatment

Key Dates

Start date
Jan 15, 2024
Status verified
Jan 2024
Primary completion
Jan 15, 2024
Completion
Apr 15, 2024

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: One Group
    Patients will be injected with 50 MU of botulinum toxin and Surface qualitative Electromyography, maximum bite force and visual pain scale will be taken before and after 1, 3 months

Primary Outcome Measure

Change in electromyographic activity of temporalis and masseter muscles bilaterally. [ Time Frame: Assessment will be done before the injection versus 1 and 3 months after injection ]

Central Contacts