Effect of Intraarticular Injection of Tenoxicam and Hyaluronic Acid Versus Platelet-Rich Plasma and Hyaluronic Acid in Temporomandibular Joint Internal Derangement

August 23, 2024 updated by: Mansoura University
To compare the effect of intraarticular injection of Tenoxicam and Hyaluronic acid Versus Platelet-rich plasma and Hyaluronic acid in the management of patients with TMJ internal derangement with reduction.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The temporomandibular joint (TMJ) is a bilateral synovial joint located on both sides of the craniomandibular complex, which is involved in chewing, swallowing, speech, and other automatic movements such as yawning, grinding, or clenching; therefore, resting the joint is challenging under normal physiological conditions, except for clamping.Consequently, TMJ pathophysiology significantly impacts individuals' ability to perform basic daily life activities and vital functions.

Temporomandibular disorders (TMDs) are characterized by several symptoms, such as pain or tiredness in the muscles of the face, soreness in the orofacial region, tenderness in the muscles, restricted jaw motion, noise at the joint, hindered jaw function, alteration or diversion, rigidity, soreness, and locking brought on by muscle spasm. TMD may also be accompanied by other neurological symptoms such as headaches, vertigo, heaviness, and impaired vision.

Pain, clicking, a misaligned jaw, and restricted jaw movement are typical symptoms of TMJ ID. The incidence of TMJ pain is shown to affect 9-15% of women and 3-10% of males in the adult population, The disease more frequently affects young persons as opposed to the degenerative lesions of the major joints, This makes TMD a significant social issue that has an impact on people's quality of life.

The primary goal of TMJID treatment is to alleviate pain, restore mandibular functions (mastication and speech), and enhance quality of life.Different therapies, including conservative treatment, minimally invasive surgical operations, and invasive surgical operations, have been widely tested to treat TMD.

Various non-surgical approaches, such as reassurance, physiotherapy, pharmacotherapy, and occlusal splint treatment, have been used to treat TMJID. Minimally invasive treatment approaches for TMJID- include arthrocentesis and intra-articular injections.

Tenoxicam (TX) is a NSAID that is used systemically or locally in joint diseases such as acute or chronic inflammatory rheumatoid arthritis and osteoarthritis.It has been reported that its long-lasting analgesic and anti-inflammatory effects are higher in intra-articular administration than in oral and intravenous administrations. However, there are few studies on intra-articular injection of tenoxicam in patients with temporomandibular joint disc displacements.

Hyaluronic acid (HA) is a high molecular-weight (high-MW) glycosaminoglycan natural synovial fluid and shares in joint lubrication.HA injections have been widely used in the management of TMJDs, and several studies showed promising results in the improvement of maximum inter-incisal opening (MIO) and pain reduction.

The viscosupplementation concept describes the physical mechanism of action mostly carried out by high-MW HAs and by- products. It is based on modifications to HA molecules to promote elasto-viscosity. While the viscoinduction effect of low MW HA, which results in therapeutic benefits after intra-articular Injection, illustrates the underlying process. As a result, the HA-based formulations recommended for the intra-articular treatment of TMJD may differ from one another.

Platelet-rich plasma (PRP) popularly considered as PRP is a concentration of platelets and related growth factors that may have therapeutic effects by attracting, promoting, and differentiating cells as well as remodeling tissue.PRP increases chondrogenic proliferation and the production of matrix molecules, which facilitates joint movement and preserves the chondral surface's overall structure.

HA and PRP mixture were used in many studies treating TMJ or other joints osteoarthritis, PRP restores intra-articular HA, increases glycosaminoglycan chondrocyte synthesis, balances joint angiogenesis, and provides a scaffold for stem cell migration.

To the best of our knowledge, no study up to date has compared the effect of intra-articular injection of a mixture of Tenoxicam and Hyaluronic acid. So, the purpose of this study will be to compare the effect of intra- articular injection of a mixture of (TX and HA) versus (PRP and HA) in the management of patients with TMJ internal derangement with reduction.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35511
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients age must be (18 -45).
  2. Patients have painful joint, clicking sound, with or without limited mouth opening.
  3. patients are unresponsive to conservative treatment.
  4. Patient's ability and desire to complete the treatment protocol and follow-up visits.
  5. Patients with internal derangement with reduction confirmed by MRI imaging.

Exclusion Criteria:

  1. Patient with an inflammatory or connective tissue disease
  2. Patient with previous invasive TMJ surgical procedure.
  3. Neurologic disorders
  4. History of injection of any substance into the target TMJ during previous 6 months.
  5. History of drug allergy.
  6. Patient with a history of bony or fibrous adhesion.
  7. Malignant disease in the head and neck region.
  8. TMJ Internal derangement without reduction.
  9. Patients respond to conservative treatment. 10.Patient with a psychological problem

11.Patients having gross mechanical restrictions and condylar fracture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients will receive a mixture of tenoxicam and HA.
The injection point will be marked Patients will be instructed to open their mouths widely and maintain the mandible in a protruded position A mixture of 1mm of TX and 1ml of HA will be slowly injected intra-articular at the point of entry.
Drug: Tenoxicam Injectable Product
(EPICOTIL® Tenoxicam 20 mg , Manufactured by: EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY, ReStore at a temperature not exceeding 30°C.)
Drug: Hyaluronic Acid 20 MG/1 ML Injection Gel/Jelly
* (Hyalubrix® hyaluronic acid sodium salt 30 MG/2 ML, manufactured by Fidia SPA,Italy, stored at temperature > 25 °C)
Experimental: patients will receive a mixture of PRP and HA.
10 ml of the patient's blood from the ulnar vein into a sterile glass tube containing sodium citrate as an anticoagulant. After mixing the blood with the citrate, using rotating movements, the tubes will be centrifuged at 1500 rpm for 6 min.The injection point will be marked Patients will be instructed to open their mouths widely and maintain the mandible in a protruded position mixture of 1-ml of PRP and 1-ml of HA will be slowly injected intra-articular at the point of entry.
Drug: Hyaluronic Acid 20 MG/1 ML Injection Gel/Jelly
* (Hyalubrix® hyaluronic acid sodium salt 30 MG/2 ML, manufactured by Fidia SPA,Italy, stored at temperature > 25 °C)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracapsular Pain and pain during movement
Time Frame: at 1 week, 4, 12, and 24 weeks
Pain intensity will be measured by VAS score. Zero score for no pain and 10 score for worst pain experienced
at 1 week, 4, 12, and 24 weeks
Clicking sound
Time Frame: at 1 week, 4, 12, and 24 weeks
Clicking sound will be assessed as to its presence = 1 or absence =0.
at 1 week, 4, 12, and 24 weeks
Maximum inter-incisal opening (MIO)
Time Frame: at 1 week, 4, 12, and 24 weeks
Maximum inter-incisal opening (MIO): was measured by Vernier caliper as the vertical distance in millimeters between the maxillary and mandibular incisal edges of the central incisors.
at 1 week, 4, 12, and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnetic Resonance Imaging (MRI) evaluation
Time Frame: will be done at 24 weeks postoperatively
Magnetic resonance imaging (MRI) (open and closed) will be done for all patients to diagnose the patients with internal derangement with reduction The MRI protocol included bilateral sagittal oblique proton-density images of the right and left sides in both the closed-mouth (maximum intercuspation) and maximum mouth opening positions.
will be done at 24 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Sally Awad, Prof, Professor of Oral and Maxillofacial Surgery Faculty of Dentistry - Mansoura University
  • Study Director: Amira Attia, Dr, Lecturer of Oral and Maxillofacial Surgery Faculty of Dentistry- Mansoura University
  • Study Director: Manar Mansour, Dr, Lecturer of Diagnostic and Interventional Radiology Faculty of Medicine- Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2024

Primary Completion (Estimated)

October 20, 2024

Study Completion (Estimated)

November 20, 2024

Study Registration Dates

First Submitted

August 23, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMJ ID

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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