Clinical trial NCT06759584: Management of Temporomandibular Disorders (TMD)
Official title: Continuous Versus Pulsed Dexamethasone Phonophoresis in Management of TMD. A Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorder
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Temporomandibular disorders (TMD) are a group of pathologies of the temporomandibular joint, their muscles, and related structures. It is considered a musculoskeletal disorder of the masticatory system, and it has a 25% prevalence in overall population.

In 3% - 7% of the population, pain and dysfunction leads to the need for treatment . The etiology of TMD is multifactorial .

Detailed description: Temporomandibular disorder is characterized by signs and symptoms that include pain, muscle tenderness, joint noises, and a limited range of motion.

The normal distance of mouth opening (inter-incisal distance) is 53 - 58mm. A minimal limit of 40 mm might be used to identify patients with limited aperture, whereas 35 mm is the necessary criteria for diagnosing disc displacement without reduction after unforced maximal aperture .

Due to all symptoms involved, a multidisciplinary approach is recommended for effective management of such cases. Conservative management of TMD treatment includes occlusal splints; physical therapy; oral medication (NSAIDs and muscle relaxants); and orthodontic treatment. Physical therapy is an important option used to reduce pain and inflammation and to improve oral mobility and function.

Phonophoresis is a method which intensifies the delivery of a topical agent into underlying tissues by ultrasound . It has been used with topical application of steroids, salicylate, anesthetic agents, methly nicotinate, NSAID . It is one of the many modalities for the treatment of musculoskeletal disorders.

Corticosteroids are used to reduce inflammation in systemic disease, local tendanitis, myositis, and other soft tissues. While these drugs are most often taken orally, they have also been applied transcutaneously by rubbing, injection, electrical current, or ultrasound. Transcutaneous drug delivery has a faster distribution rate into the system once it diffuses through the outer layer of the skin, quickly reaching the arterioles in the epithelium it is carried out systemically. As the blood moves through the vessels, part of the drug leaks into the surrounding tissues. These advantages have justified researching different methods to enhance transcutaneous delivery, avoiding unnecessary prolonged drug contact.

Eligibility criteria: Inclusion Criteria:

* patients 20- 50 years showing TMD
* pain \> 3 on Visual Analog scale (VAS)
* failed pharmacological treatment

Exclusion Criteria:

* electrical stimulator or pacemaker
* cancer or any other severe or mental diseases
* osteoarthritis, inflammation, infection, or radiation on the TMJ articulation,
* joint cement or plastic components on TMJ articulation

Primary outcomes:
measure: Management of Pain
timeFrame: First 24 hours after The Operations
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Dentistry, Minia University
Study officials:
affiliation: Faculty of Dentistry, Minia University
name: Tarek Abdelbarry, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: