MESNA Injection for TMJ Internal Derangement

NCT05882604 | Completed DMC

• 1 other identifier: #R-OS-4-23-3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

TMJ Disorder

Outcome Measures

Primary Outcomes (1)

• maximal interincisal opening (MIO)

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

  6 months

Secondary Outcomes (2)

• Joint pain

  6 months

• clicking sound

  6 months

Study Arms (2)

Intra-articular injection with MESNA solution

EXPERIMENTAL

1 ml of MESNA will be injected intra-articular

Drug: Mesna Injection

Arthrocentesis with ringer solution

ACTIVE COMPARATOR

ringer solution will be used for arthrocentesis

Drug: Arthrocentesis with ringer solution

Interventions

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.

Intra-articular injection with MESNA solution

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

Arthrocentesis with ringer solution

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with TMJ internal derangement with reduction

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Tanta, 6624033, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Mesna; Arthrocentesis; Ringer's Solution

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• 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: May 22, 2023
• First Posted: May 31, 2023
• Study Start: March 1, 2023
• Primary Completion: March 10, 2024
• Study Completion: March 10, 2024
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)