Two Treatment Modalities for Myogenous Temporomandibular Disorders

NCT07351812 | Recruiting

• 1 other identifier: 0999_11/2024
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

TMD

Outcome Measures

Primary Outcomes (2)

• Change in Muscle activity

  surface electromyography will be used to assess the temporalis and masseter muscles. The electrodes detect the electrical potentials generated by muscle fibers when they contract. This electrical activity is amplified and recorded by an electromyograph machine

  Baseline and 3 months

• Change in mouth opening

  Measure the distance (in mm) between the incisal edge of the maxillary and mandibular central incisors

  Baseline and 3 months

Secondary Outcomes (1)

• Change in pain

  Baseline and 3 months

Study Arms (2)

Stabilization appliance

EXPERIMENTAL

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

Other: Stabilization Appliance

Ear stent

ACTIVE COMPARATOR

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

Other: Ear Stent

Interventions

Stabilization Appliance OTHER

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.

Stabilization appliance

Ear Stent OTHER

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.

Ear stent

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

RECRUITING

Central Study Contacts

Alaa F Mohamed, BDS

CONTACT

01018135577; alaa127fikrey@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 20, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-12

Locations

EG (1)