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

ConditionsMandibular SplintBotoxLateral PterygoidCervical Muscle ActivityTemporomandibular Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorCairo University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

33 Participants
are divided into 3 treatment groups
Group A: Botox injection groupExperimental treatment 1 intervention
Group B: Mandibular stabilization splint groupExperimental treatment 1 intervention
Group C: Control groupActive comparator 1 intervention

Trial outcomes

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

Time frame
After injection for 3 months.

Secondary outcomes

1

Amplitude of muscle activity

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

Time frame
After injection for 3 months.
2

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.

Time frame
After injection for 3 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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