Arthrocentesis Alone Versus Arthrocentesis With Hyaluronic Acid Injection

NCT ID: NCT05962619

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-08-02

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 .

Conditions

Temporomandibular Joint Dysfunction Syndrome; Arthrocenteses; Hyaluronic Acid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

arthrocentesis alone

Intervention Type: PROCEDURE

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

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

Group Type: EXPERIMENTAL

arthrocentesis with hyaluronic acid injection

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohammed Hussein Ali

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ahmed Hussien, MBBH

Role: CONTACT

ahmed.s7s1929@gmail.com

01014417626

Mohammed MD Osman, MD

Role: CONTACT

dr.osman@aun.edu.eg

01223971586

Other Identifiers

AHAI

Identifier Type: -

Identifier Source: org_study_id