Arthrocentesis Alone Versus Arthrocentesis With Hyaluronic Acid Injection

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

Comparison between Arthrocentesis alone arthrocentesis with hyaluronic acid injection in management of temporomandibular joint dysfunction in the form of anterior disc displacement with reduction.

Study Overview

• Status: Not yet recruiting
• Conditions: Temporomandibular Joint Dysfunction Syndrome; Hyaluronic Acid; Arthrocenteses
• Intervention / Treatment: Procedure: arthrocentesis alone; Procedure: arthrocentesis with hyaluronic acid injection

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 .

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Hussien, MBBH; Phone Number: 01014417626; Email: ahmed.s7s1929@gmail.com
• Study Contact Backup: Name: Mohammed MD Osman, MD; Phone Number: 01223971586; Email: dr.osman@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arthrocentesis alone; 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.	Procedure: arthrocentesis alone; 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
Experimental: arthrocentesis with hyaluronic acid injection; 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	Procedure: arthrocentesis with hyaluronic acid injection; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Three months
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	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Three months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 2, 2024

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: AHAI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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