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NCT Number: NCT06553950

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

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

Recruiting

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 11796, Egypt

Location status: Recruiting

Location contact

Aya A Khalil, MD

SUB_INVESTIGATOR

Kerolos G Abd-El Malak, MBBCH

CONTACT

[email protected]

00201276145151

Soheir S Rizkallah, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Botox injection

Drug

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.

Mandibular stabilization splint

Drug

Patients will be treated by mandibular stabilization splint and medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.

muscle relaxant

Drug

Patients will be treated by medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.

Primary outcomes

  1. Muscle activity of upper trapizieus and sternocleidomastoid

    Time frame: After injection for 3 months.

    Muscle activity of upper trapizieus and sternocleidomastoid will be recorded before and after injection for 3 months by neurosoft Electromyography

Secondary outcomes

  1. Amplitude of muscle activity

    Time frame: After injection for 3 months.

    Amplitude of muscle activity will be recorded before and after injection for 3 months by neurosoft Electromyography.

  2. Root mean square of muscle activity

    Time frame: After injection for 3 months.

    Root mean square of muscle activity will be recorded before and after injection for 3 months by neurosoft Electromyography.

Study contacts

Contact information is provided by the study sponsor or research team.

Kerolos G Abd-El Malak, MBBCH

CONTACT

[email protected]

00201276145151

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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