Comparing mandibular splints and Botox injections for jaw pain relief
Mandibular Splint Versus Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular Disorders
This study is testing whether a mouthguard or Botox injections can help young adults with jaw pain feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06553950 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of mandibular splints and Botox injections in the lateral pterygoid muscle on cervical muscle activity in patients suffering from temporomandibular disorders (TMD). TMD is a common condition characterized by pain and dysfunction in the jaw joint and surrounding muscles. The study will include patients aged 18-40 with specific types of mandibular disc displacement and muscle spasms. Participants will receive either a mandibular splint or Botox injection to assess which treatment provides better relief from symptoms.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-40 with a diagnosis of anterior mandibular disc displacement and cervical muscle spasms lasting more than three months.
Not a fit: Patients with bilateral anterior mandibular disc displacement or those with significant neurological or musculoskeletal diseases affecting the cervical spine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective treatment option for managing temporomandibular disorders.
How similar studies have performed: Previous studies have shown varying success with both mandibular splints and Botox injections for TMD, but this specific comparison is less commonly explored.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Kerolos G Abd-El Malak, MBBCH
- Email: Kerols.ghobreal@deraya.edu.eg
- Phone: 00201276145151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.