Management of Temporomandibular Disorders (TMD)

Minia University

Status: Completed

Conditions: Temporomandibular Disorder

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT06759584

Temporomandibular disorders

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups

Group A

Active Comparator group

Description:

About 20 patients who will receive dexamethasone gel and continuous phonophoresis

Treatment:

Drug: Dexamethasone

Group B

Active Comparator group

Description:

About 20 patients who will receive dexamethasone and pulsed phonophoresis

Treatment:

Drug: Dexamethasone

Group C

Active Comparator group

Description:

About 20 patients who will receive acoustic gel and continuous phonophoresis

Treatment:

Drug: Dexamethasone

Group D

Active Comparator group

Description:

About 20 patients who will receive acoustic gel and pulsed phonophoresis

Treatment:

Drug: Dexamethasone