Two treatments for muscle-related TMJ pain
Evaluation of Two Treatment Modalities for Myogenous Temporomandibular Disorders: A Randomized Controlled Trial
This trial will try a mouth stabilization appliance and a new ear stent to see which better reduces muscle-related jaw pain in people with myogenous TMD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT07351812 on ClinicalTrials.gov |
What this trial studies
This is a randomized clinical trial comparing a conventional intraoral stabilization appliance with a recently introduced ear stent for patients diagnosed with myogenous temporomandibular disorder. Eligible participants have at least moderate jaw muscle pain (≥4/10 on the NRS), fully dentate type I occlusion, and no neurological or systemic contraindications; arthrogenous cases are excluded by MRI. Participants will be randomly assigned to one of the two devices and followed for changes in pain and related jaw function. The goal is to determine which noninvasive modality provides greater symptomatic relief for muscle-related TMD.
Who should consider this trial
Good fit: Adults with myogenous TMD who report at least moderate jaw muscle pain (≥4/10), have fully dentate type I occlusion, and no neurological or uncontrolled systemic disease are ideal candidates.
Not a fit: People with joint-related (arthrogenous) TMD, clicking or crepitation, prior TMD treatment, recent trauma, certain systemic or neurologic disorders, or recent injections/neck surgery are unlikely to benefit from these specific interventions.
Why it matters
Potential benefit: If successful, one of these simple, noninvasive devices could provide better pain relief and improved daily function for people with muscle-related TMJ pain.
How similar studies have performed: Stabilization appliances are widely used with supporting evidence for TMD, while the ear stent is a newer device with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants presenting with pain score grading at least 4 out of 10 on NRS. * Participants with fully dentate type I occlusion. * Patients experiencing no neurological disorders. Exclusion Criteria: * Patients with arthrogenous TMJ will be excluded by Magnetic Resonance Imagining (MRI) * Patients who have clicking or crepitation. * Previous history of TMD treatment. * History of recent trauma. * The presence of systemic diseases (i.e., rheumatoid arthritis, osteoarthritis myologic or arthrological disease). * Vascular disease (migraine and hypertension). * Participants with uncontrolled systemic disease (diabetes), hematologic or neurologic disorders or inflammatory diseases. * Patients who: Underwent trigger point myofascial injection, intramuscular stimulation, or dry needling in the last six months or Underwent neck and/or shoulder surgery in the last year.
Where this trial is running
Alexandria
- Alexandria Faculty of Dentistry — Alexandria, Egypt (Recruiting)
Study contacts
- Study coordinator: Alaa F Mohamed, BDS
- Email: alaa127fikrey@gmail.com
- Phone: 01018135577
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.