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

NCT ID: NCT06553950

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-14
• Study Completion Date: 2025-02-01

Brief Summary

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

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Botox injection

Intervention Type: 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 group

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

Group Type: EXPERIMENTAL

Mandibular stabilization splint

Intervention Type: DRUG

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

Control group

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

Group Type: ACTIVE_COMPARATOR

Muscle relaxant

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Mandibular stabilization splint

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

Intervention Type: DRUG

Muscle relaxant

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

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Kerolos Ghobrial Goda Abd-El Malak

Resident of Physical Therapy , Faculty of Physical Therapy ,Cairo University, Cairo, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Kerolos G Abd-El Malak, MBBCH

Role: CONTACT

Kerols.ghobreal@deraya.edu.eg

00201276145151

Facility Contacts

Kerolos G Abd-El Malak, MBBCH

Role: primary

Kerols.ghobreal@deraya.edu.eg

00201276145151

Other Identifiers

P.T.REC/012/004426

Identifier Type: -

Identifier Source: org_study_id