Clinical trial NCT06553950: Mandibular Splint vs Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular Disorders
Official title: Mandibular Splint Versus Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mandibular Splint
Botox
Lateral Pterygoid
Cervical Muscle Activity
Temporomandibular Disorders
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to compere mandibular splint versus botox injection in lateral pterygoid on cervical muscle activity in patients with temporomandibular disorders

Detailed description: Temporomandibular disorders (TMD) are common chronic musculoskeletal pain conditions among orofacial pain, consisting of a group of conditions associated with pain and dysfunction of the temporomandibular joint (TMJ) and masticatory muscles. Temporomandibular joint displacement, also known as internal disc derangement, is an abnormal relationship between the articular disc, the mandibular condyle, and the mandibular fossa. The most frequent displacement of the disc is anterior to the mandibular condyle however, in rare cases it can be posteriorly.

Occlusal splint treatment is generally considered to be a basic treatment for Temporomandibular disorders. It could promote correction of the vertical dimension, maxillo-mandibular realignment, temporomandibular joint repositioning and cognitive awareness. Although various splints are currently available, the most used are stabilization splints and anterior repositioning splints.

Injection of BTX-A in LP muscle, considering the different methods, frequencies and injection dosages used in different studies, would decrease the clicks and other TMJ-related disorders such as pain, hyperactivity, and dysfunction. Based on the present review, most studies about the injection of botulinum toxin in LP muscle reported cases or were done as quasi-experimental studies.

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

* 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, congenital myopathies, myotonic disorders, mitochondrial myopathy and unspecified or other primary muscle disorders).
* 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).

Primary outcomes:
measure: Muscle activity of upper trapizieus and sternocleidomastoid
timeFrame: After injection for 3 months.
Secondary outcomes:
measure: Amplitude of muscle activity
timeFrame: After injection for 3 months.
measure: Root mean square of muscle activity
timeFrame: After injection for 3 months.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: