Actively Recruiting
Mandibular Splint Versus Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular Disorders
Led by Cairo University · Updated on 2024-08-16
33
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of mandibular splint and Botox injection in the lateral pterygoid muscle on cervical muscle activity in patients with temporomandibular disorders (TMD). TMD involves pain and dysfunction in the jaw joint and muscles controlling jaw movement, often caused by internal displacement of the joint's disc. The study addresses common chronic musculoskeletal pain conditions affecting the orofacial area, focusing on how different treatments may influence muscle activity in this population. Participants are randomly assigned to one of three groups: Botox injection in the lateral pterygoid muscle combined with medications (muscle relaxants, antidepressants, and nonsteroidal anti-inflammatory drugs); mandibular stabilization splint combined with the same medications; or medication treatment alone. Botox is prepared at a concentration of 10 units per 0.1 mL and injected into the affected muscle, while the splint is worn as a dental device to realign the jaw. The study period includes treatment and follow-up to assess outcomes over three months. During the study, researchers measure muscle activity in the upper trapezius and sternocleidomastoid muscles three months after treatment. They evaluate amplitude and root mean square of muscle activity to assess treatment effects. Participants undergo regular monitoring, including assessments of symptoms and muscle function, with attention to safety and adherence. The total study duration extends from enrollment until three months post-treatment, with ongoing observation of cervical muscle activity changes.
CONDITIONS
Brief Title
Mandibular Splint vs Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 40 years old
- Both sexes are eligible
- Duration of temporomandibular disorder symptoms is more than 3 months
- Diagnosis of anterior mandibular disc displacement with reduction
- Unilateral anterior mandibular displacement with reduction grade 2 or 3 (Wilkes classification)
- Presence of cervical muscle spasm and trigger points in upper trapezius and sternocleidomastoid muscles
- Sufficient cognitive ability to understand and follow instructions
You will not qualify if you...
- Neurological or musculoskeletal diseases affecting the cervical spine other than mandibular disc displacement (e.g., cervical spondylosis, spondylolisthesis, cervical disc injuries)
- Bilateral anterior mandibular disc displacement
- Severe arthritis, cervical spine surgery, contractures, or fixed deformity
- Leg length discrepancy
- Pregnancy or lactation
- Known hypersensitivity to any component of the study drug, especially human albumin
- Infection or inflammation at the planned injection site
- Musculoskeletal conduction disorders or primary muscular disorders (e.g., muscular dystrophy, neuromyopathy, myotonic disorders)
- Treatment with certain medications such as aminoglycoside antibiotics, ciclosporin, D-penicillamine, tubocurarine, pancuronium, gallamine, succinylcholine, chloroquine, or hydroxychloroquine
- History of cervical spine surgery or trauma
- Signs of cervical radiculopathy or myelopathy
- Vascular syndromes like vertebrobasilar insufficiency
- Signs of serious pathology such as malignancy, inflammatory disorders, or infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive either Botox injection in the lateral pterygoid muscle, a mandibular stabilization splint, or medications including muscle relaxants, antidepressants, and nonsteroidal anti-inflammatory drugs to manage temporomandibular disorders.
Visits as required for treatment administration and monitoring
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, Egypt, 11796
Actively Recruiting
Research Team
K
Kerolos G Abd-El Malak, MBBCH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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