Two Treatment Modalities for Myogenous Temporomandibular Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stabilization Appliance, Ear Stent.
- Who it may be relevant to
- Registry conditions: TMD. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Two Treatment Modalities for Myogenous Temporomandibular Disorders: A Randomized Controlled Trial
Overview
Temporomandibular disorder (TMD) is a common condition with multifactorial etiology, including trauma, emotional stress, parafunctional habits, and occlusal discrepancies. TMD may be classified as myogenous, involving the masticatory and cervical muscles, or arthrogenous, affecting the temporomandibular joint structures. Management approaches range from noninvasive to invasive methods. The intraoral stabilization appliance (SA) is a widely used noninvasive treatment, while the ear stent (ES) has recently been introduced for managing myogenous TMD. Aim: This randomized clinical trial aims to compare the effectiveness of SA and ES in the management of myogenous TMD.
Interventions
- Other Stabilization Appliance
Participants will receive a maxillary stabilization appliance fabricated from 2-mm hard thermoplastic material using diagnostic casts. The appliance fit will be verified, and patients will be instructed to wear it for 3 months. - Other Ear Stent
Participants will undergo ENT evaluation prior to ear impression taking. Custom ear stents will be fabricated from soft addition silicone and hollowed to prevent hearing impairment.
Primary outcome measures
- Change in Muscle activity [Time frame: Baseline and 3 months]
- Change in mouth opening [Time frame: Baseline and 3 months]
Secondary outcome measures (1)
- Change in pain [Time frame: Baseline and 3 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Alexandria Faculty of Dentistry — Alexandria
Identifiers
NCT: NCT07351812 · 0999_11/2024