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

Last updated: August 14, 2024
Sponsor: Cairo University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Oral Facial Pain

Treatment

Muscle relaxant

Botox injection

Mandibular stabilization splint

Clinical Study ID

NCT06553950
P.T.REC/012/004426
  • Ages 18-40
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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) willbe 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 andfollow instructions.

Exclusion

Exclusion Criteria:

  • Neurological or musculoskeletal diseases that affect cervical spine other thanmandibular disc displacement (eg: cervical spondylosis, spondylolisthesis, andcervical disc injuries)

  • Bilateral anterior mandibular disc displacement patients.

  • Musculoskeletal disorders such as severe arthritis, cervical spine surgery orcontractures of fixed deformity, leg length discrepancy.

  • women during pregnancy and lactation.

  • Patients with known hypersensitivity to any component of the drug (especiallyhypersensitivity to human albumin).

  • Patients with infection or inflammation of the area where the toxin injections areplanned, in patients with musculoskeletal conduction disorders, in primary musculardisorders (muscular dystrophy, neuromyopathy, congenital myopathies, myotonicdisorders, mitochondrial myopathy and unspecified or other primary muscledisorders).

  • 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).

Study Design

Total Participants: 33
Treatment Group(s): 3
Primary Treatment: Muscle relaxant
Phase:
Study Start date:
August 14, 2024
Estimated Completion Date:
February 01, 2025

Study 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.

Connect with a study center

  • Cairo University

    Cairo, 11796
    Egypt

    Active - Recruiting

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