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Intra-articular Injection of Medications in TMJ After Arthrocentsis

No phase Interventional Internal Derangement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Arthrocentesis with ringer solution, Arthrocentesis with ringer solution.
Who it may be relevant to
Registry conditions: Internal Derangement. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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: A Randomized Clinical Trial

Overview

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 .

Detailed description

II. Introduction:

6\. Background and rationale: Research question? In patients with anterior disc displacement with reduction, what is the therapeutic effect of intra-articular injection of hyaluronic acid and corticosteroids mixture after arthrocentesis versus hyaluronic acid and prp mixture after arthrocentesis in terms of jaw movement, pain relief, decreasing clicking and frequency of locking?

Statement of the problem:

Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases.

Hyaluronic acid and corticosteroids mixture have been proved in literature to represent a more effective method to preserve and treat joints (knee joints and temporomandibular joints)

Rationale for conducting the research:

The rationale of this procedure is to remove inflammatory mediators, reduce friction, stimulate the production of new synovial fluid, eliminate suction-cup effect.

The purpose of this study was to evaluate the hypothesis that TMJ injection of hyaluronic acid and corticosteroids mixture after arthrocentesis leads to better clinical outcomes in terms of reducing pain and improving function compared with injection of hyaluronic acid and prp mixture after arthrocentesis in patients with TMJ internal derangement and osteoarthritis Preliminary results of this clinical trial show that the injection of hyaluronic acid and corticosteroids mixture can significantly improve outcomes of pain and function compared with the standard treatment and encourage to pursue research on this topic.

Further studies with a longer follow-up time are needed to evaluate the clinical stability of the achieved improvement in pain and function.

For this reason, this protocol has been designed with the aim to investigate whether injection in the TMJ of hyaluronic acid and corticosteroids mixture after can achieve the same improvements of pain and function, compare this technique with hyaluronic acid and platelet rich plasma mixture injection.

Review of literature Anterior disc displacement with reduction of the temporomandibular joint (TMJ) is a prevalent condition characterized by the displacement of the articular disc during jaw movement, often leading to pain, clicking sounds, and restricted mouth opening. Traditional treatments include conservative approaches such as physical therapy, occlusal splints, and pharmacological interventions. However, for patients unresponsive to these methods, intra-articular injections of therapies like hyaluronic acid, corticosteroids mixture and hyaluronic acid, platelet-rich plasma (PRP)mixture have emerged as promising alternatives.

Arthrocentesis 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. Recently, studies have explored the combined use of HA and CS, aiming to capitalize on the anti-inflammatory effects of CS and the viscoelastic, lubricating, and regenerative properties of HA.

1. Hyaluronic Acid in TMJ Disorders:

HA is a natural component of synovial fluid and plays a critical role in joint lubrication and cartilage health.

In a systematic review, intra-articular HA injections showed significant improvements in pain and jaw function in patients with TMDs HA promotes endogenous synthesis of proteoglycans, reduces cartilage degradation, and provides mechanical cushioning. 2. Corticosteroids in TMJ Disorders:

CS are potent anti-inflammatory agents that reduce joint pain and inflammation by inhibiting cytokine production and leukocyte infiltration.

intra-articular CS injections lead to short-term pain relief but could result in cartilage damage if overused.

Side effects of repeated CS injections may include joint degeneration and reduced joint space. 3. Combined HA and CS Injections:

The combination aims to provide rapid pain relief (via CS) while enhancing joint lubrication and healing (via HA).

a randomized clinical trial comparing HA alone, CS alone, and a mixture of both. The HA+CS group showed faster pain relief and better functional recovery at early time points, although long-term outcomes were similar to HA alone.

Yilmaz : Found that the combined injection provided superior improvement in mouth opening and pain control compared to either agent alone.

HA+CS combination is effective in patients with internal derangement and osteoarthritis of the TMJ, especially when guided by ultrasound for accurate injection placement.

Hyaluronic acid and PRP mixture injection The synergistic effect of HA and PRP is hypothesized to enhance joint function and alleviate pain more effectively than either agent alone.

Clinical Evidence

Several studies have investigated the efficacy of HA and PRP combination therapy:

Synergistic Effect Study: A randomized controlled trial . demonstrated that patients receiving combined HA and PRP injections post-arthrocentesis experienced significant improvements in pain reduction and maximum mouth opening compared to those receiving either HA or PRP alone.

Comparative Study: evaluated the participation of HA with PRP in the treatment of TMJ disorders. Their study found that the combination therapy provided greater improvements in pain at mastication, masticatory efficiency, and functional limitation in mandibular movement over a 6-month follow-up period compared to HA alone.

Systematic Review: A systematic review indicated that while arthrocentesis alone effectively reduces pain and improves jaw function, additional injections of HA or PRP do not significantly enhance clinical outcomes. However, the combination of HA and PRP may offer synergistic benefits, though further high-quality studies are needed to confirm this.

Comparative Efficacy While both hyaluronic acid, corticosteroids mixture and hyaluronic acid, prp mixture injections have demonstrated efficacy in treating joint disorders, direct comparative studies in the context of TMJ anterior disc displacement with reduction are limited. The existing literature primarily focuses on individual therapies rather than head-to-head comparisons. Therefore, it is challenging to definitively conclude which treatment offers superior outcomes for TMJ disorders.

Explanation for choice of comparator

A) The choice of a hyaluronic acid (HA) and corticosteroids (CS) mixture injection in the treatment of anterior disc displacement with reduction of the temporomandibular joint (TMJ) is based on anti-inflammatory effects to manage symptoms and improve joint function. Here's a breakdown of the rationale:

1. Pathophysiology of Anterior disc displacement with reduction In Anterior disc displacement with reduction, the disc moves anteriorly during mouth closure and returns to its normal position during opening, often producing clicking sounds.

Repetitive disc displacement can lead to synovial inflammation, joint effusion, and cartilage wear, which result in pain and functional limitation 2. Why Hyaluronic Acid? Lubrication: HA restores the viscosity of synovial fluid, reducing friction between joint surfaces.

Shock Absorption: It protects joint structures during mandibular movements. Anti-inflammatory effects: HA can inhibit inflammatory mediators like IL-1 and prostaglandins.

Cartilage Protection: It promotes chondrocyte activity and slows down degenerative changes. 3. Why Corticosteroids? Potent anti-inflammatory: CS reduce synovial inflammation quickly by suppressing cytokines and inflammatory cell activity.

Pain relief: CS can rapidly decrease pain by reducing joint swelling and pressure.

Short-term efficacy: Especially useful in acute or highly symptomatic cases. 4. Why the Combination? Complementary action: CS provide rapid symptom relief, while HA supports longer-term joint health.

Interventions

  • Combination product Arthrocentesis with ringer solution
    HA + Corticosteroid Group Patients receive intra-articular injection of a hyaluronic acid (HA) and corticosteroid mixture after arthrocentesis.
  • Combination product Arthrocentesis with ringer solution
    HA + PRP Group Patients receive intra-articular injection of a hyaluronic acid (HA) and platelet-rich plasma (PRP) mixture after arthrocentesis

Primary outcome measures

  • 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 [Time frame: 3 months]
Secondary outcome measures (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 [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of dentistry cairo university — Cairo

Identifiers

NCT: NCT07598253 · TMJ Arthrocentesis

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗