Actively Recruiting
Evaluation of Two Treatment Modalities for Myogenous Temporomandibular Disorders: A Randomized Controlled Trial
Led by Alexandria University · Updated on 2026-01-20
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Temporomandibular disorder (TMD) is a common condition caused by many factors such as trauma, emotional stress, habits, and bite problems. It can affect the muscles involved in chewing (myogenous) or the joint structures (arthrogenous). This trial focuses on myogenous TMD and aims to compare two treatment methods: the widely used stabilization appliance (SA) and the newer ear stent (ES). Participants will be randomly assigned to one of two groups. The first group will receive a maxillary stabilization appliance made from hard thermoplastic material, worn for 3 months. The second group will receive a custom ear stent made from soft silicone, worn full-time except during meals, showering, or swimming. Before treatment, patients will have impressions taken and evaluations to ensure proper fit and safety. During the study, muscle activity of jaw muscles and mouth opening will be measured at the start and after 3 months to evaluate changes. Pain levels will also be tracked. Participants will undergo clinical assessments including dental impressions and ear exams. The study runs from January 2025 to June 2026 and is sponsored by Alexandria University.
CONDITIONS
Brief Title
Two Treatment Modalities for Myogenous Temporomandibular Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with jaw muscle pain scoring at least 4 out of 10 on the numeric rating scale
- Fully dentate participants with type I occlusion
- No neurological disorders present
You will not qualify if you...
- Patients with arthrogenous temporomandibular joint disorder as confirmed by MRI
- Patients experiencing clicking or crepitation sounds in the jaw
- Previous history of temporomandibular disorder treatment
- History of recent trauma
- Presence of systemic diseases such as rheumatoid arthritis, osteoarthritis, or other myologic or arthrological diseases
- Vascular diseases including migraine and hypertension
- Uncontrolled systemic diseases like diabetes, hematologic, neurologic, or inflammatory disorders
- Patients who had trigger point myofascial injection, intramuscular stimulation, or dry needling within the last six months
- Patients who underwent neck or shoulder surgery in the last year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants will receive either a maxillary stabilization appliance to wear for 3 months or a custom ear stent to wear full-time except during meals, showering, or swimming.
1 baseline visit and 1 follow-up visit after 3 months
Trial Site Locations
Total: 1 location
1
Alexandria Faculty of Dentistry
Alexandria, Egypt
Actively Recruiting
Research Team
A
Alaa F Mohamed, BDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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