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NCT Number: NCT07351812

Two Treatment Modalities for Myogenous Temporomandibular Disorders

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.

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Key information

Conditions

TMD

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location status: Recruiting

Location contact

Alaa F Mohamed, BDS

PRINCIPAL_INVESTIGATOR

Alaa F Mohamed, MS

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Muscle activity

    Time frame: Baseline and 3 months

    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

  2. Change in mouth opening

    Time frame: Baseline and 3 months

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

Secondary outcomes

  1. Change in pain

    Time frame: Baseline and 3 months

    NRS will be measured from the patient mark from 0 to 10, where 0 representing no pain and 10 representing the worst pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Alaa F Mohamed, BDS

CONTACT

[email protected]

01018135577

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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