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

NCT06553950 | Recruiting

• 1 other identifier: P.T.REC/012/004426
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mandibular Splint; Botox; Lateral Pterygoid; Cervical Muscle Activity; Temporomandibular Disorders

Outcome Measures

Primary Outcomes (1)

• Muscle activity of upper trapizieus and sternocleidomastoid

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

  After injection for 3 months.

Secondary Outcomes (2)

• Amplitude of muscle activity

  After injection for 3 months.

• Root mean square of muscle activity

  After injection for 3 months.

Study Arms (3)

Botox injection group

EXPERIMENTAL

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

Drug: Botox injection

Mandibular stabilization splint group

EXPERIMENTAL

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

Drug: Mandibular stabilization splint

Control group

ACTIVE COMPARATOR

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

Drug: Muscle relaxant

Interventions

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.

Botox injection group

Mandibular stabilization splint DRUG

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

Mandibular stabilization splint group

Muscle relaxant DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Kerolos G Abd-El Malak, MBBCH

CONTACT

00201276145151; Kerols.ghobreal@deraya.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Physical Therapy , Faculty of Physical Therapy ,Cairo University, Cairo, Egypt.

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 14, 2024
• Study Start: August 14, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)