Treatment of Temporomandibular Joint Internal Derangement Using MESNA Injection
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- maximal interincisal opening (MIO)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with TMJ internal derangement with reduction
Exclusion Criteria
- •inflammatory or connective tissue disease
- •autoimmune disease history
- •neurologic problems
Arms & Interventions
Intra-articular injection with MESNA solution
1 ml of MESNA will be injected intra-articular
Intervention: Mesna Injection (Drug)
Arthrocentesis with ringer solution
ringer solution will be used for arthrocentesis
Intervention: Arthrocentesis with ringer solution (Drug)
Outcomes
Primary Outcomes
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
- Joint pain(6 months)
- clicking sound(6 months)
Investigators
Ahmed Abdellatif Abdelfatah
Lecturer of oral and maxillofacial surgery
Tanta University