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Completed

NCT Number: NCT05882604

MESNA Injection for TMJ Internal Derangement

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

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Key information

Conditions

TMJ Disorder Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, 6624033, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with TMJ internal derangement with reduction

Exclusion criteria

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

Treatment and study plan

Mesna Injection

Drug

1 ml of MESNA will be injected using 20-guage needle in he upper compartment of TMJ in patient with internal derrangement.

Arthrocentesis with ringer solution

Drug

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

Primary outcomes

  1. maximal interincisal opening (MIO)

    Time frame: 6 months

    a digital caliper will be employed to measure the maximum interincisal opening pre and postoperative

Secondary outcomes

  1. 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

  2. clicking sound

    Time frame: 6 months

    yes or no questionnaire,yes mean clicking is present and no means clicking disappeared

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Treatment of Temporomandibular Joint Internal Derangement Using MESNA Injection

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 31, 2023
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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