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Compares treatment options for Mandibular Splint
Official title Mandibular Splint vs Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular Disorders
ClinicalTrials.gov ID: NCT06553950
What this study is testing
What is Botox injection?
Botox injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for mandibular splint.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to compere mandibular splint versus botox injection in lateral pterygoid on cervical muscle activity in patients with temporomandibular disorders
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40
You may be able to join if
- Age from 18-40 years old.
- Both sexes.
- Duration of the disease is more than 3 months.
- Anterior mandibular disc displacement with reduction will be included.
- Unilateral anterior mandibular displacement with reduction grade 2\&3 (Wilkes) will be included.
You likely can't join if
- Neurological or musculoskeletal diseases that affect cervical spine other than mandibular disc displacement (eg: cervical spondylosis...
- Bilateral anterior mandibular disc displacement patients.
- Musculoskeletal disorders such as severe arthritis, cervical spine surgery or contractures of fixed deformity, leg length discrepancy.
- women during pregnancy and lactation.
- Patients with known hypersensitivity to any component of the drug (especially hypersensitivity to human albumin).
- Patients with infection or inflammation of the area where the toxin injections are planned, in patients with musculoskeletal conduction disorders, in...
See the full eligibility criteria
- Age from 18-40 years old.
- Both sexes.
- Duration of the disease is more than 3 months.
- Anterior mandibular disc displacement with reduction will be included.
- Unilateral anterior mandibular displacement with reduction grade 2\&3 (Wilkes) will be included.
- Patients with cervical muscles spasm and trigger points (upper trapezius\& sternocleidomastoid) will be included.
- Patients with sufficient cognitive abilities that enables them to understand and follow instructions.
- Neurological or musculoskeletal diseases that affect cervical spine other than mandibular disc displacement (eg: cervical spondylosis, spondylolisthesis, and cervical disc injuries)
- Bilateral anterior mandibular disc displacement patients.
- Musculoskeletal disorders such as severe arthritis, cervical spine surgery or contractures of fixed deformity, leg length discrepancy.
- women during pregnancy and lactation.
- Patients with known hypersensitivity to any component of the drug (especially hypersensitivity to human albumin).
- Patients with infection or inflammation of the area where the toxin injections are planned, in patients with musculoskeletal conduction disorders, in primary muscular disorders (muscular dystrophy, neuromyopathy...
- Patients being treated with aminoglycoside antibiotics, ciclosporin, D-penicillamine, tubocurarine, pancuronium, gallamine, succinylcholine, chloroquine, or hydroxychloroquine.
- History of cervical spine surgery.
- History of trauma or fractures in cervical spine.
- Signs of cervical radiculopathy or myelopathy.
- Vascular syndrome such as vertebrobasilar insufficiency.
- Signs of serious pathology ( e.g., malignancy, inflammatory disorders, infection).
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.