MESNA Injection for TMJ Internal Derangement

NCT ID: NCT05882604

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-03-10

Brief Summary

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

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.

Conditions

TMJ Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intra-articular injection with MESNA solution

1 ml of MESNA will be injected intra-articular

Group Type: EXPERIMENTAL

Mesna Injection

Intervention Type: 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

ringer solution will be used for arthrocentesis

Group Type: ACTIVE_COMPARATOR

Arthrocentesis with ringer solution

Intervention Type: 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

Interventions

Mesna Injection

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients with TMJ internal derangement with reduction

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdellatif Abdelfatah

Lecturer of oral and maxillofacial surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, Tanta, Egypt

Countries

Egypt

Other Identifiers

#R-OS-4-23-3

Identifier Type: -

Identifier Source: org_study_id