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Search / Trial NCT06553950

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

Launched by CAIRO UNIVERSITY · Aug 12, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is comparing two different treatments for people suffering from temporomandibular disorders (TMD), which can cause pain and discomfort in the jaw and neck. The study is looking at the effectiveness of a mandibular splint (a type of mouthguard) versus Botox injections in a specific muscle (the lateral pterygoid) to see which one helps reduce muscle activity in the neck area. If you or a family member are between the ages of 18 and 40, have had TMD for more than three months, and have certain types of jaw issues, you might qualify to participate in this study.

Participants in the trial can expect to receive one of the two treatments and will be monitored for how it affects their neck muscles and overall comfort. It's important to know that there are specific health conditions that could prevent someone from taking part, such as certain neurological issues or recent surgeries. This trial is currently recruiting participants, so it’s a great opportunity for those looking for relief from TMD symptoms.

Gender

ALL

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).

About Cairo University

Cairo University, a premier institution in Egypt, is dedicated to advancing medical research and education through innovative clinical trials. With a strong emphasis on improving healthcare outcomes, the university collaborates with various stakeholders to conduct rigorous scientific studies that address critical health challenges. Leveraging its extensive resources and expert faculty, Cairo University aims to contribute valuable insights to the medical community and enhance patient care both locally and globally. Through its commitment to ethical research practices and excellence, the university plays a pivotal role in shaping the future of healthcare in the region.

Locations

Cairo, , Egypt

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported