Cairo University
Cairo, 11796, Egypt
Location status: Recruiting
Location contact
Aya A Khalil, MD
SUB_INVESTIGATOR
Kerolos G Abd-El Malak, MBBCH
CONTACT
Soheir S Rizkallah, MD
SUB_INVESTIGATOR
NCT Number: NCT06553950
The study aims to compere mandibular splint versus botox injection in lateral pterygoid on cervical muscle activity in patients with temporomandibular disorders
Interested in participating?
Request Info18 year–40 year
All sexes
Interventional
Not applicable
Cairo, 11796, Egypt
Location status: Recruiting
Aya A Khalil, MD
SUB_INVESTIGATOR
Kerolos G Abd-El Malak, MBBCH
CONTACT
Soheir S Rizkallah, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Patients will be treated by mandibular stabilization splint and medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.
Patients will be treated by medications like muscle relaxants, antidepressants and nonsteroidal anti-inflammatory drugs.
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
Time frame: After injection for 3 months.
Amplitude of muscle activity will be recorded before and after injection for 3 months by neurosoft Electromyography.
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.
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Mandibular Splint Versus Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular Disorders
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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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