Arthrocentesis Alone Versus Arthrocentesis With Hyaluronic Acid Injection

NCT05962619 | Unknown

• 1 other identifier: AHAI
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Temporomandibular Joint Dysfunction Syndrome; Arthrocenteses; Hyaluronic Acid

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Clicking

  Three months

Study Arms (2)

Arthrocentesis alone

EXPERIMENTAL

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

arthrocentesis with hyaluronic acid injection

EXPERIMENTAL

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

Interventions

arthrocentesis alone 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 alone

arthrocentesis with hyaluronic acid injection 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

arthrocentesis with hyaluronic acid injection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Interventions

Arthrocentesis; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Temporomandibular Joint Disorders; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Myofascial Pain Syndromes; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Ahmed Hussien, MBBH

CONTACT

01014417626; ahmed.s7s1929@gmail.com

Mohammed MD Osman, MD

CONTACT

01223971586; dr.osman@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 27, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 2, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share