MESNA Injection for TMJ Internal Derangement
Primary Purpose
TMJ Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mesna Injection
Arthrocentesis with ringer solution
Sponsored by
About this trial
This is an interventional treatment trial for TMJ Disorder
Eligibility Criteria
Inclusion Criteria: patients with TMJ internal derangement with reduction Exclusion Criteria: inflammatory or connective tissue disease autoimmune disease history neurologic problems
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intra-articular injection with MESNA solution
Arthrocentesis with ringer solution
Arm Description
1 ml of MESNA will be injected intra-articular
ringer solution will be used for arthrocentesis
Outcomes
Primary Outcome Measures
maximal interincisal opening (MIO)
a digital caliper will be employed to measure the maximum interincisal opening pre and postoperative
Secondary Outcome Measures
Joint pain
pain will be assessed on a visual analogue scale (VAS) with a score between 0 and 10
clicking sound
yes or no questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05882604
Brief Title
MESNA Injection for TMJ Internal Derangement
Official Title
Treatment of Temporomandibular Joint Internal Derangement Using MESNA Injection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TMJ Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intra-articular injection with MESNA solution
Arm Type
Experimental
Arm Description
1 ml of MESNA will be injected intra-articular
Arm Title
Arthrocentesis with ringer solution
Arm Type
Active Comparator
Arm Description
ringer solution will be used for arthrocentesis
Intervention Type
Drug
Intervention Name(s)
Mesna Injection
Intervention Description
1 ml of MESNA will be injected using 20-guage needle in he upper compartment of TMJ in patient with internal derrangement.
Intervention Type
Drug
Intervention Name(s)
Arthrocentesis with ringer solution
Intervention Description
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
Primary Outcome Measure Information:
Title
maximal interincisal opening (MIO)
Description
a digital caliper will be employed to measure the maximum interincisal opening pre and postoperative
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Joint pain
Description
pain will be assessed on a visual analogue scale (VAS) with a score between 0 and 10
Time Frame
6 months
Title
clicking sound
Description
yes or no questionnaire
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with TMJ internal derangement with reduction
Exclusion Criteria:
inflammatory or connective tissue disease
autoimmune disease history
neurologic problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed A Abdelfatah, PhD
Phone
01094279620
Email
drahmed_maxillofacial@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
MESNA Injection for TMJ Internal Derangement
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