Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572904
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Effect of Intraarticular Injection of Tenoxicam and Hyaluronic Acid Versus Platelet-Rich Plasma and Hyaluronic Acid in Temporomandibular Joint Internal Derangement
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Intraarticular Injection of Tenoxicam and Hyaluronic Acid Versus Platelet-Rich Plasma and Hyaluronic Acid in Temporomandibular Joint Internal Derangement
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 clampingConsequently 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 people39s quality of life
The primary goal of TMJID treatment is to alleviate pain restore mandibular functions mastication and speech and enhance quality of lifeDifferent 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 osteoarthritisIt 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 lubricationHA 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 tissuePRP increases chondrogenic proliferation and the production of matrix molecules which facilitates joint movement and preserves the chondral surface39s 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
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 people39s quality of life
The primary goal of TMJID treatment is to alleviate pain restore mandibular functions mastication and speech and enhance quality of lifeDifferent 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 osteoarthritisIt 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 lubricationHA 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 tissuePRP increases chondrogenic proliferation and the production of matrix molecules which facilitates joint movement and preserves the chondral surface39s 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None