Management of Temporomandibular Disorders (TMD)

NCT ID: NCT06759584

Last Updated: 2025-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-28

Study Completion Date

2024-02-28

Brief Summary

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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

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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.

Conditions

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Temporomandibular Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A

About 20 patients who will receive dexamethasone gel and continuous phonophoresis

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

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

Group B

About 20 patients who will receive dexamethasone and pulsed phonophoresis

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

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

Group C

About 20 patients who will receive acoustic gel and continuous phonophoresis

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

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

Group D

About 20 patients who will receive acoustic gel and pulsed phonophoresis

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

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

Interventions

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Dexamethasone

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

Intervention Type DRUG

Other Intervention Names

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Phonophoresis

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Tarek Abdelbarry

Lecturer of Oral and Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tarek Abdelbarry, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Minia University

Locations

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Faculty of Dentistry, Minia University

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Temporomandibular disorders

Identifier Type: -

Identifier Source: org_study_id

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