NCT06759584

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
Last Updated

January 6, 2025

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

December 28, 2024

Last Update Submit

December 28, 2024

Conditions

Outcome Measures

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.

    First 24 hours after The Operations

Study Arms (4)

Group A

ACTIVE COMPARATOR

About 20 patients who will receive dexamethasone gel and continuous phonophoresis

Drug: Dexamethasone

Group B

ACTIVE COMPARATOR

About 20 patients who will receive dexamethasone and pulsed phonophoresis

Drug: Dexamethasone

Group C

ACTIVE COMPARATOR

About 20 patients who will receive acoustic gel and continuous phonophoresis

Drug: Dexamethasone

Group D

ACTIVE COMPARATOR

About 20 patients who will receive acoustic gel and pulsed phonophoresis

Drug: Dexamethasone

Interventions

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

Also known as: Phonophoresis
Group AGroup BGroup CGroup D

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Minia University

Minya, 2431412, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

DexamethasonePhonophoresis

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Tarek Abdelbarry, Lecturer

    Faculty of Dentistry, Minia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

December 28, 2024

First Posted

January 6, 2025

Study Start

April 28, 2023

Primary Completion

February 20, 2024

Study Completion

February 28, 2024

Last Updated

January 6, 2025

Record last verified: 2023-04

Locations