Health TrialsbyHealthPanel

Two Treatment Modalities for Myogenous Temporomandibular Disorders

ConditionTMD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorAlexandria University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stabilization Appliance

    Other intervention

    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 intervention

    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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Stabilization applianceExperimental treatment 1 intervention
Group B: Ear stentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline and 3 months
2

Change in mouth opening

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

Time frame
Baseline and 3 months

Secondary outcomes

1

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.

Time frame
Baseline and 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Source ClinicalTrials.gov
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