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MESNA Injection for TMJ Internal Derangement

Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05882604
Collaborator
(none)
12
Enrollment
2
Arms
7
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Mesna Injection
  • Drug: Arthrocentesis with ringer solution
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Treatment of Temporomandibular Joint Internal Derangement Using MESNA Injection
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intra-articular injection with MESNA solution

1 ml of MESNA will be injected intra-articular

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.
Active Comparator: Arthrocentesis with ringer solution

ringer solution will be used for arthrocentesis

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

Outcome Measures

Primary Outcome Measures

  1. maximal interincisal opening (MIO) [6 months]

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

Secondary Outcome Measures

  1. Joint pain [6 months]

    pain will be assessed on a visual analogue scale (VAS) with a score between 0 and 10

  2. clicking sound [6 months]

    yes or no questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Abdellatif Abdelfatah, Lecturer of oral and maxillofacial surgery, Tanta University
ClinicalTrials.gov Identifier:
NCT05882604
Other Study ID Numbers:
  • #R-OS-4-23-3
First Posted:
May 31, 2023
Last Update Posted:
May 31, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Mesna

Study Results

No Results Posted as of May 31, 2023