Two Treatment Modalities for Myogenous Temporomandibular Disorders

Evaluation of Two Treatment Modalities for Myogenous Temporomandibular Disorders: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: TMD
• Intervention / Treatment: Other: Stabilization Appliance; Other: Ear Stent

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alaa F Mohamed, BDS; Phone Number: 01018135577; Email: alaa127fikrey@gmail.com

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria Faculty of Dentistry
    • Contact: Alaa F Mohamed, MS; Email: alaa127fikrey@gmail.com
    • Principal Investigator: Alaa F Mohamed, BDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stabilization appliance; 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; 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.
Active Comparator: Ear stent; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain	NRS will be measured from the patient mark from 0 to 10, where 0 representing no pain and 10 representing the worst pain.	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 20, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 0999_11/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No