Intra-articular Injection of Medications in TMJ After Arthrocentsis

NCT07598253 | Not Yet Recruiting

• 1 other identifier: TMJ Arthrocentesis
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study: to evaluate the injection of hyaluronic acid and corticosteroids mixture leads to better clinical outcomes in terms of improve maximum mouth opening and reduce pain compared with hyaluronic acid and prp mixture in patients with TMJ internal derangement .

Conditions

Internal Derangement

Keywords

corticosteroids , PrP , hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Evaluation of the efficacy of intra-articular injection of hyaluronic acid and corticosteroids mixture versus hyaluronic acid and platelet rich plasma mixture after arthrocentesis in anterior disc displacement with reduction

  measuring the maximum mouth opening

  3 months

Secondary Outcomes (1)

• Evaluation of the efficacy of intra-articular injection of hyaluronic acid and corticosteroids mixture versus hyaluronic acid and platelet rich plasma mixture after arthrocentesis in anterior disc displacement with reduction

  3 months

Study Arms (2)

Patients receive intra-articular injection of a hyaluronic acid and corticosteroids mixture

ACTIVE COMPARATOR

Arthrocentesis first described by Nitzan et al. \[1.2\] is the simplest intervention on the TMJ with the aim to decrease joint pain and improve the range of motion in patients not responding to initial conservative treatment. Arthrocentesis consists of an intraarticular lavage using 2 needles placed in the upper joint space. It is a versatile technique which can be performed under local anesthesia in an outpatient setting as well Arthrocentesis has been demonstrated to be a very effective procedure with a high success rate and a favorable benefit-cost ratio. In addition to arthrocentesis: Hyaluronic acid and corticosteroids mixture injection Introduction: Temporomandibular joint disorders (TMDs) represent a diverse group of conditions affecting the TMJ, masticatory muscles, and associated structures. Intra-articular injections of therapeutic agents, particularly Hyaluronic Acid (HA) and Corticosteroids (CS), have been utilized to reduce inflammation and improve joint mobility. Recentl

Combination Product: Arthrocentesis with ringer solution

Patients receive intra-articular injection of a hyaluronic acid (HA) and platelet-rich plasma

EXPERIMENTAL

Arthrocentesis first described by Nitzan et al. \[1.2\] is the simplest intervention on the TMJ with the aim to decrease joint pain and improve the range of motion in patients not responding to initial conservative treatment. Arthrocentesis consists of an intraarticular lavage using 2 needles placed in the upper joint space. It is a versatile technique which can be performed under local anesthesia in an outpatient setting as well Arthrocentesis has been demonstrated to be a very effective procedure with a high success rate and a favorable benefit-cost ratio.double-puncture arthrocentesis technique was followed, and 300 mL of Ringer's lactate solution was used to irrigate the joint space through the marked points . After arthrocentesis standard treatment Preparation of platelet-rich plasma First, 5 ml blood is withdrawn from the patient. Then, blood is poured in a test-tube in which sodium citrate anticoagulant (0.5 ml) is already present. It is centrifuged at the rate of 2100 rpm for

Combination Product: Arthrocentesis with ringer solution

Interventions

Arthrocentesis with ringer solution COMBINATION_PRODUCT

HA + Corticosteroid Group Patients receive intra-articular injection of a hyaluronic acid (HA) and corticosteroid mixture after arthrocentesis.

Patients receive intra-articular injection of a hyaluronic acid and corticosteroids mixture

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients should have one or more signs and symptoms of these
• Symptoms: Patients who report typical symptoms of TMJ dysfunction, such as pain, discomfort, or clicking sounds in the joint, especially when opening or closing the mouth.
• Mouth Opening: Limited range of motion or difficulty with full mouth opening.
• Clicking: Audible clicking.
• Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck.

You may not qualify if:

• \* Previously diagnosed hematological and neurological conditions;
• Previous malignant head and neck neoplasms;
• Uncooperative patients.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry cairo university

Cairo, Cairo Governorate, 11553, Egypt

Location

MeSH Terms

Interventions

Arthrocentesis; Ringer's Solution

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mohamed Ashraf Eissa, Assisstant professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar Hamdy Negm, BDS Oral and dental medicine

CONTACT

+20 1002006335; omarhamdynegm@gmail.com

Omar Hamdy Negm, BDS oforal and dental medicine

CONTACT

+20 1002006335; omarhamdynegm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Omar Hamdy Abdelsalam Negm

Model Details: The participants will be randomly divided into two groups In group A (Hyaluronic acid and corticosteroids mixture injection): I - double-puncture arthrocentesis technique was followed, and 300 mL of Ringer's lactate solution was used to irrigate the joint space through the marked points. After arthrocentesis a mixture of 1-ml HA and 1-ml corticosteroid (Kenacort A-40: each ml contains triamcinolone acetonide 40mg. with sodium chloride manufactured by SmithKline Beecham, Egypt. An affiliated Co. to GlaxoSmithKline) was slowly injected. Each patient received a single injection, once the injection was completed and needles were removed, the patient's mandible was lightly manipulated in the vertical, protrusive, and lateral excursions to facilitate breaking down the adhesions and help additional freeing up

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

EG (1)