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Two Treatment Modalities for Myogenous Temporomandibular Disorders

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07351812
Enrollment
32
Registered
2026-01-20
Start date
2025-01-01
Completion date
2026-06-01
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TMD

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.

Interventions

OTHERStabilization 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.

OTHEREar 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.

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Muscle activityBaseline and 3 monthssurface 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
Change in mouth openingBaseline and 3 monthsMeasure the distance (in mm) between the incisal edge of the maxillary and mandibular central incisors

Secondary

MeasureTime frameDescription
Change in painBaseline and 3 monthsNRS will be measured from the patient mark from 0 to 10, where 0 representing no pain and 10 representing the worst pain.

Countries

Egypt

Contacts

CONTACTAlaa F Mohamed, BDS
alaa127fikrey@gmail.com01018135577

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026