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Arthrocentesis Alone Versus Arthrocentesis With Hyaluronic Acid Injection

Primary Purpose

Temporomandibular Joint Dysfunction Syndrome, Arthrocenteses, Hyaluronic Acid

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
arthrocentesis alone
arthrocentesis with hyaluronic acid injection
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Dysfunction Syndrome

Eligibility Criteria

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

Inclusion Criteria: Adults with age between( 18-45) years Both genders The cases ciinically have either of ( limitation of mouth opening , pre-auricular pain , headache, temporal, and occipital tenderness ) and radiologically (MRI) diagnosed as ADD with reduction The patients have symptom durations for more than 3 months with medical treatment. Patients whom did not respond to medical treatment Exclusion Criteria: Previous TMJ surgery or previous arthrocentesis. Patients with arthritis or history of condylar trauma Patients with degenerative change of the condylar head and with facial asymmetry, retrognathism, or prognathism Severe co-morbid conditions (uncontrolled diabetes, Hypertenion

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Arthrocentesis alone

    arthrocentesis with hyaluronic acid injection

    Arm Description

    Arthrocentesis alone in management of temporomandibular joint dysfunction in the form of anterior disc displacement with reduction.by lavage by normal saline and during the lavage the mandible is moved through opening, excursive, and protrusive movements to facilitate lysis of adhesions.

    arthrocentesis with hyaluronic acid injection in management of temporomandibular joint dysfunction in the form of anterior disc displacement with reduction. after arthrocentesis is completed, lavage is done by hyaluronic acid injection

    Outcomes

    Primary Outcome Measures

    Mouth opening
    Maximum inter-incisal opening (MIO): measured by Vernier caliper in millimeters (mm) as the vertical distance between the incisal edges of maxillary and mandibular central incisors. Preoperative and postoperative measurement of MIO would help in evaluation of improvement in mouth opening after arthrocentesis
    Tempero mandibular joint pain
    Pain was assessed using visual analogue scale (VAS): which ranges from zero to 10 (where zero refers to no pain, 1:3 mild pain, 4:6 moderate pain, 7:9 severe pain and 10 maximum pain) assessing pre and post operative will provide good evidence about effect of arthrocentesis in decrease Tempero mandibular joint pain

    Secondary Outcome Measures

    Clicking
    Clicking was assessed as its presence or absence where zero refers to absence of clicking, 1 indicates decrease in sound and frequency of clicking, and 2 indicates presence of clicking.Assessment of clicking showed that there was statistically significant difference between the two groups along the evaluation intervals. There was statistically significant difference between clicking scores at the baseline when compared to the follow-up intervals within both groups

    Full Information

    First Posted
    June 12, 2023
    Last Updated
    July 25, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05962619
    Brief Title
    Arthrocentesis Alone Versus Arthrocentesis With Hyaluronic Acid Injection
    Official Title
    Arthrocentesis Alone Versus Arthrocentesis With Hyaluronic Acid Injection in Management of Temporomandibular Joint Dysfunction in the Form of Anterior Disc Displacement With Reduction : a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2024 (Anticipated)
    Study Completion Date
    August 2, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Comparison between Arthrocentesis alone arthrocentesis with hyaluronic acid injection in management of temporomandibular joint dysfunction in the form of anterior disc displacement with reduction.
    Detailed Description
    Temporomandibular joint (TMJ) anterior disc displacement (ADD) is one of the most common TMJ disorders.It can occur in all age groups, with a high prevalence in adolescents . ADD often presents with clicking, joint pain, a limited range of mouth opening. Furthermore,ADD might lead to osteoarthrosis . Since ADD of the TMJ can lead to various harmful outcomes, how to manage ADD is considered a key problem for most TMJ experts. It has been difficult for most clinicians to select a suitable method for ADD patients with different grades of severitis ). Initially, these conditions can be managed conservatively by employing techniques such as occlusal splint therapy, physiotherapy, pharmacotherapy and occlusal treatments. If Medical treatment fails, minimally invasive (sodium hyaluronate or corticosteroid infiltrations and arthrocentesis) and invasive treatments (arthroscopy, arthroplasty, arthrotomy, discectomy, condylotomy) are formed ). Sodium hyaluronate is a buffered solution of hyaluronate acid sodium salt, which is an essential component of the cartilage.It acts against the disintegration of the extracellular matrix.It reduces friction, and it features an anti-inflamatory effect. It is indicated for the treatment of osteoarthritic symptoms and inflammatory degenerative joint disease). Intra-articular hyaluronic acid injection provides long-term palliative effects on symptoms and signs of TMJ pain .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporomandibular Joint Dysfunction Syndrome, Arthrocenteses, Hyaluronic Acid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arthrocentesis alone
    Arm Type
    Experimental
    Arm Description
    Arthrocentesis alone in management of temporomandibular joint dysfunction in the form of anterior disc displacement with reduction.by lavage by normal saline and during the lavage the mandible is moved through opening, excursive, and protrusive movements to facilitate lysis of adhesions.
    Arm Title
    arthrocentesis with hyaluronic acid injection
    Arm Type
    Experimental
    Arm Description
    arthrocentesis with hyaluronic acid injection in management of temporomandibular joint dysfunction in the form of anterior disc displacement with reduction. after arthrocentesis is completed, lavage is done by hyaluronic acid injection
    Intervention Type
    Procedure
    Intervention Name(s)
    arthrocentesis alone
    Intervention Description
    The procedure is done under general anesthesia. The patient is seated inclined at a 45 degree angle with the head turned to contralateral side. The points of needle insertion on the skin, are as follow: a line is drawn from the middle of the tragus to the outer canthus of the eye. The posterior entrance point is located along the canthotragal line, 10 mm from the middle of the tragus line and 2 mm below, the anterior entrance point is placed 10 mm further forward along the line and 10 mm below it . A needle connected to a 10 ml syringe with the Ringer's lactate solution is then inserted into the superior compartment (posterior point), and solution is injected . Another needle is then inserted into the area of articular eminence to enable the free flow of solution through the superior compartment. During the lavage, the mandible is moved through opening, excursive, and protrusive movements to facilitate lysis of adhesions
    Intervention Type
    Procedure
    Intervention Name(s)
    arthrocentesis with hyaluronic acid injection
    Intervention Description
    in this group Once arthrocentesis is completed, an ampule of sodium HA (Hyalgan 1 ml) is connected to the needle in situ And 0.5 ml injected into the superior joint space. Pressure dressing is placed in site of injection. so We use arthrocentesis hyaluronic acid injection in management of temporomandibular joint dysfunction in the form of anterior disc displacement with reduction
    Primary Outcome Measure Information:
    Title
    Mouth opening
    Description
    Maximum inter-incisal opening (MIO): measured by Vernier caliper in millimeters (mm) as the vertical distance between the incisal edges of maxillary and mandibular central incisors. Preoperative and postoperative measurement of MIO would help in evaluation of improvement in mouth opening after arthrocentesis
    Time Frame
    Three months
    Title
    Tempero mandibular joint pain
    Description
    Pain was assessed using visual analogue scale (VAS): which ranges from zero to 10 (where zero refers to no pain, 1:3 mild pain, 4:6 moderate pain, 7:9 severe pain and 10 maximum pain) assessing pre and post operative will provide good evidence about effect of arthrocentesis in decrease Tempero mandibular joint pain
    Time Frame
    One month
    Secondary Outcome Measure Information:
    Title
    Clicking
    Description
    Clicking was assessed as its presence or absence where zero refers to absence of clicking, 1 indicates decrease in sound and frequency of clicking, and 2 indicates presence of clicking.Assessment of clicking showed that there was statistically significant difference between the two groups along the evaluation intervals. There was statistically significant difference between clicking scores at the baseline when compared to the follow-up intervals within both groups
    Time Frame
    Three months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults with age between( 18-45) years Both genders The cases ciinically have either of ( limitation of mouth opening , pre-auricular pain , headache, temporal, and occipital tenderness ) and radiologically (MRI) diagnosed as ADD with reduction The patients have symptom durations for more than 3 months with medical treatment. Patients whom did not respond to medical treatment Exclusion Criteria: Previous TMJ surgery or previous arthrocentesis. Patients with arthritis or history of condylar trauma Patients with degenerative change of the condylar head and with facial asymmetry, retrognathism, or prognathism Severe co-morbid conditions (uncontrolled diabetes, Hypertenion
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Hussien, MBBH
    Phone
    01014417626
    Email
    ahmed.s7s1929@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohammed MD Osman, MD
    Phone
    01223971586
    Email
    dr.osman@aun.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Arthrocentesis Alone Versus Arthrocentesis With Hyaluronic Acid Injection

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