MESNA Injection for TMJ Internal Derangement

Not Applicable

Completed

• Conditions: TMJ Disorder
• Interventions: Drug: Mesna Injection; Drug: Arthrocentesis with ringer solution

• Registration Number: NCT05882604
• Lead Sponsor: Tanta University

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

Not available

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-05-31
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients with TMJ internal derangement with reduction

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-articular injection with MESNA solution	Mesna Injection	1 ml of MESNA will be injected intra-articular
Arthrocentesis with ringer solution	Arthrocentesis with ringer solution	ringer solution will be used for arthrocentesis

Primary Outcome Measures

Name	Time	Method
maximal interincisal opening (MIO)	6 months	a digital caliper will be employed to measure the maximum interincisal opening pre and postoperative

Secondary Outcome Measures

Name	Time	Method
Joint pain	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
clicking sound	6 months	yes or no questionnaire,yes mean clicking is present and no means clicking disappeared

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, Egypt