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Mandibular Splint vs Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular Disorders

Cairo University (CU) logo

Cairo University (CU)

Status

Enrolling

Conditions

Lateral Pterygoid
Cervical Muscle Activity
Mandibular Splint
Temporomandibular Disorders
Botox

Treatments

Drug: Botox injection
Drug: Muscle relaxant
Drug: Mandibular stabilization splint

Study type

Interventional

Funder types

Other

Identifiers

NCT06553950
P.T.REC/012/004426

Details and patient eligibility

About

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

Full 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.

Enrollment

33 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

33 participants in 3 patient groups

Botox injection group
Experimental group
Description:
Patients will be treated by Botox injection in lateral pterygoid muscle and medications like muscle relaxants, antidepressants, and nonsteroidal anti-inflammatory drugs. A Botox-A vial was diluted with normal saline to a concentration of 10 U per 0.1 mL for injection in a 1-ml insulin syringe. This will be injected into the ipsilateral lateral pterygoid muscle
Treatment:
Drug: Botox injection
Mandibular stabilization splint group
Experimental group
Description:
Patients will be treated by mandibular stabilization splint and medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.
Treatment:
Drug: Mandibular stabilization splint
Control group
Active Comparator group
Description:
Patients will be treated by medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.
Treatment:
Drug: Muscle relaxant

Trial contacts and locations

1

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Central trial contact

Kerolos G Abd-El Malak, MBBCH

Data sourced from clinicaltrials.gov

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