Two Treatment Modalities for Myogenous Temporomandibular Disorders

Alexandria University

Status: Enrolling

Conditions: TMD

Treatments: Other: Ear Stent; Other: Stabilization Appliance

Study type: Interventional

Funder types: Other

Identifiers

NCT07351812

0999_11/2024

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Stabilization appliance

Experimental group

Description:

Maxillary and mandibular impressions will be taken using irreversible hydrocolloid and poured immediately with Type IV dental stone to obtain study casts. A maxillary stabilization appliance will be fabricated according to Okeson et al. using 2-mm hard thermoplastic sheets. The appliance will have a flat occlusal surface with buccal extensions, and its fit and retention will be verified. Participants will wear the appliance for 3 months. Surface electromyography of the temporalis and masseter muscles will be recorded at baseline and after 3 months to assess changes in muscle activity

Treatment:

Other: Stabilization Appliance

Ear stent

Active Comparator group

Description:

Participants will undergo ENT evaluation to exclude ear pathology and remove cerumen. Ear impressions will be taken using soft addition silicone injected with a 3.5-mm syringe and sent to a hearing-aid laboratory for fabrication. The stent will be hollowed longitudinally to prevent hearing impairment. Patients will be instructed to wear the stent full-time, removing it only during meals, showering, or swimming

Treatment:

Other: Ear Stent