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CompletedNCT06759584Updated Jan 6, 2025

Management of Temporomandibular Disorders (TMD)

An interventional study of Dexamethasone in Temporomandibular Disorder, sponsored by Minia University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-01-06.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Apr 2023, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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 .

Read the 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.

02

Conditions studied

03

In context

Temporomandibular Joint Disorders

609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.

This study's enrollment of 80 is above the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Group A

    About 20 patients who will receive dexamethasone gel and continuous phonophoresis

    Drug: Dexamethasone

  • Active comparator
    Group B

    About 20 patients who will receive dexamethasone and pulsed phonophoresis

    Drug: Dexamethasone

  • Active comparator
    Group C

    About 20 patients who will receive acoustic gel and continuous phonophoresis

    Drug: Dexamethasone

  • Active comparator
    Group D

    About 20 patients who will receive acoustic gel and pulsed phonophoresis

    Drug: Dexamethasone

Interventions

  • DrugDexamethasone

    To Compare clinical outcome of dexamethasone phonophoresis in a (continuous and pulsed) maneuver for management of Temporomandibular Disorders

    Also known as: Phonophoresis

06

What researchers measure

Primary outcomes

  1. Management of Pain

    Pain scores will be recorded on visual analog scale (VAS) using a 0 to 10 pain score basis with 0 being no pain and 10 being the worst pain the patient had ever experienced.

    Time frame: First 24 hours after The Operations

07

Study locations

1 site
  • Faculty of Dentistry, Minia University
    Minya, 2431412, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06759584
Lead sponsor
Minia University
Responsible party
Tarek Abdelbarry (Lecturer of Oral and Maxillofacial Surgery, Minia University) — Principal investigator
First posted
Jan 6, 2025
Start date
Apr 28, 2023
Primary completion
Feb 20, 2024
Completion
Feb 28, 2024
Last update
Jan 6, 2025

Study contacts

Tarek Abdelbarry, Lecturer
principal investigator · Faculty of Dentistry, Minia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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