Clinical trial NCT06572904: Effect of Intraarticular Injection of Tenoxicam and Hyaluronic Acid Versus Platelet-Rich Plasma and Hyaluronic Acid in Temporomandibular Joint Internal Derangement
Official title: Effect of Intraarticular Injection of Tenoxicam and Hyaluronic Acid Versus Platelet-Rich Plasma and Hyaluronic Acid in Temporomandibular Joint Internal Derangement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Temporomandibular Joint Internal Derangement
Keywords: Tenoxicam
ID
PRP
TMD
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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\&#39;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\&#39;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.

Eligibility criteria: 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

Primary outcomes:
measure: Intracapsular Pain and pain during movement
timeFrame: at 1 week, 4, 12, and 24 weeks
measure: Clicking sound
timeFrame: at 1 week, 4, 12, and 24 weeks
measure: Maximum inter-incisal opening (MIO)
timeFrame: at 1 week, 4, 12, and 24 weeks
Secondary outcomes:
measure: Magnetic Resonance Imaging (MRI) evaluation
timeFrame: will be done at 24 weeks postoperatively
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
Study officials:
affiliation: Professor of Oral and Maxillofacial Surgery Faculty of Dentistry - Mansoura University
name: Sally Awad, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Oral and Maxillofacial Surgery Faculty of Dentistry- Mansoura University
name: Amira Attia, Dr
role: STUDY_DIRECTOR
affiliation: Lecturer of Diagnostic and Interventional Radiology Faculty of Medicine- Mansoura University
name: Manar Mansour, Dr
role: STUDY_DIRECTOR
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