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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
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TMJ Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 22, 2023
    Last Updated
    May 22, 2023
    Sponsor
    Tanta University
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    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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