MESNA Injection for TMJ Internal Derangement

TMJ Disorder Clinical Trial

Official title:

Treatment of Temporomandibular Joint Internal Derangement Using MESNA Injection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05882604
• Other study ID #: #R-OS-4-23-3
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Tanta University
• Contact: Ahmed A Abdelfatah, PhD
• Phone: 01094279620
• Email: drahmed_maxillofacial[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with TMJ internal derangement with reduction

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Temporomandibular Joint Disorders
• TMJ Disorder

Intervention

Drug:
• Mesna Injection
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
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

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximal interincisal opening (MIO)	a digital caliper will be employed to measure the maximum interincisal opening pre and postoperative	6 months
Secondary	Joint pain	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	6 months
Secondary	clicking sound	yes or no questionnaire,yes mean clicking is present and no means clicking disappeared	6 months