MESNA Injection for TMJ Internal Derangement

July 20, 2025 updated by: Ahmed Abdellatif Abdelfatah, Tanta University

Treatment of Temporomandibular Joint Internal Derangement Using MESNA Injection

The pathogenesis of temporomandibular disorders focusing on the biochemistry of the synovial fluid in various stages of temporomandibular joint disease. The role of inflammation has been investigated and proposed as an underlying mechanism of pain and dysfunction of temporomandibular joint. MESNA (sodium 2-mercaptoethanesulfonate) was approved several years ago and marketed in several formulations as a mucolytic agent in the respiratory field, since it breaks the disulfide bonds between polypeptide chains of mucus. The tissue distribution of MESNA is negligible, and the elimination of the substance is rapidly and completely achieved by kidney

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Clarification (July 2025): Recruitment was completed in March 2023 following clinical scheduling and preliminary departmental clearance, while formal written ethical approval was finalized in early April 2023. All patients were followed up for one year, and the study was completed by March 2024.

Study Type

Interventional

Enrollment (Actual)

60

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 Locations

  • Egypt
      • Tanta, Egypt, 6624033
        • Tanta University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients with TMJ internal derangement with reduction

Exclusion Criteria:

  • inflammatory or connective tissue disease
  • autoimmune disease history
  • neurologic problems

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intra-articular injection with MESNA solution
1 ml of MESNA will be injected intra-articular
Drug: Mesna Injection
1 ml of MESNA will be injected using 20-guage needle in he upper compartment of TMJ in patient with internal derrangement.
Active Comparator: Arthrocentesis with ringer solution
ringer solution will be used for arthrocentesis
Drug: Arthrocentesis with ringer solution
Two 20-gauge needles will be placed into upper joint space as entry and exit points for washing.The arthrocentesis will be performed with 100 ml of lactated Ringer's solution to eliminate the inflammatory mediators present in the synovial fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximal interincisal opening (MIO)
Time Frame: 6 months
a digital caliper will be employed to measure the maximum interincisal opening pre and postoperative
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Joint pain
Time Frame: 6 months
pain will be assessed on a visual analogue scale (VAS) with a score between 0 and 10, 0 means no pain and 10 means severe pain
6 months
clicking sound
Time Frame: 6 months
yes or no questionnaire,yes mean clicking is present and no means clicking disappeared
6 months

Collaborators and Investigators

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

Sponsor

Tanta 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 (Actual)

March 1, 2023

Primary Completion (Actual)

March 10, 2024

Study Completion (Actual)

March 10, 2024

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

July 24, 2025

Last Update Submitted That Met QC Criteria

July 20, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #R-OS-4-23-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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