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

Mandibular Splint Versus 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

Study Overview

• Status: Recruiting
• Conditions: Temporomandibular Disorders; Mandibular Splint; Lateral Pterygoid; Cervical Muscle Activity; Botox
• Intervention / Treatment: Drug: Botox injection; Drug: Mandibular stabilization splint; Drug: Muscle relaxant

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.

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kerolos G Abd-El Malak, MBBCH; Phone Number: 00201276145151; Email: Kerols.ghobreal@deraya.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • Recruiting
    • Cairo University
    • Contact: Kerolos G Abd-El Malak, MBBCH; Phone Number: 00201276145151; Email: Kerols.ghobreal@deraya.edu.eg
    • Sub-Investigator: Soheir S Rizkallah, MD
    • Sub-Investigator: Aya A Khalil, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botox injection group; 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; 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.
Experimental: Mandibular stabilization splint group; Patients will be treated by mandibular stabilization splint and medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.	Drug: Mandibular stabilization splint; Patients will be treated by mandibular stabilization splint and medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.
Active Comparator: Control group; Patients will be treated by medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.	Drug: Muscle relaxant; Patients will be treated by medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amplitude of muscle activity	Amplitude of muscle activity will be recorded before and after injection for 3 months by neurosoft Electromyography.	After injection for 3 months.
Root mean square of muscle activity	Root mean square of muscle activity will be recorded before and after injection for 3 months by neurosoft Electromyography.	After injection for 3 months.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: P.T.REC/012/004426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No