Assessment of Concentric Needle Technique in Temporomandibular Joint (TMJ) Internal Derangement.

August 19, 2022 updated by: Ahmed Adel Hassan Mahmoud, Cairo University

Assessment of Concentric Needle Technique for the Management of Temporomandibular Joint Internal Derangement Randomized Controlled Trial (RCT)

The aim of the study is to evaluate the effectivenes of using two concentric needles in comaprsion with the normal traditional two distant needles.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with age ranges from 18-60.
  2. Patients with painful clicking.
  3. Patients free of systemic conditions that might affect the TMJ or interfere with carrying out the surgical procedure (osteoarthritis, rheumatoid arthritis, uncontrolled diabetes).

Exclusion Criteria:

  1. Patients out of the specified range group
  2. Patients with painless TMJ clicking.
  3. Patients with osteo-arthritic changes of the TMJ.
  4. Patients with systemic conditions that might affect the TMJ or interfere with carrying out the surgical procedure (osteoarthritis, rheumatoid arthritis, uncontrolled diabetes).
  5. Patients with previous TMJ surgeries.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study group
Concentric needle technique TMJ arthrocentesis using lactated ringer solution to help reduce inflammatory mediators and anterior disc discplacement with reduction
Procedure: Arthrocentesis
Injection of lactated ringer solution in the TMJ to wash out inflammatory mediators and help reducing anterior disc displacement with reduction
Active Comparator: Control group
Double needle technique TMJ arthrocentesis using lactated ringer solution to help reduce inflammatory mediators and anterior disc discplacement with reduction
Procedure: Arthrocentesis
Injection of lactated ringer solution in the TMJ to wash out inflammatory mediators and help reducing anterior disc displacement with reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain felt during the procedure TMJ arthrocentesis
Time Frame: baseline
Visual analogue scale from zero to ten (zero indicates no pain and ten indicates worst pain)
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Concentric needle technique

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on TMJ Disc Disorder

Clinical Trials on Arthrocentesis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe