Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403046
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-05-03
Brief Title:
Effect of Intra-articular Injection of Tenoxicam or Meloxicam in TMJ Anterior Disc Displacement With Reduction
Sponsor:
Beni-Suef University
Organization:
Beni-Suef University
Study Overview
Official Title:
Does Intra-articular Injection of Tenoxicam or Meloxicam After Arthrocentesis Affect Treatment Outcomes of Temporomandibular Joint Anterior Disc Displacement With Reduction A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The temporomandibular joints TMJ articular disc situated between the mandibular condyles convexity and the articular tubercles slope is the most intricate synovial articulation in the human body While the usual discal position as defined by magnetic resonance imaging MRI places the posterior discal band at the 12 oclock position atop the mandibular condyles maximum convexity this discal disposition is altered in over 30 of the population without any accompanying physical symptoms This denotes that rather than correcting the anatomical disc position the treatment for discal displacement would primarily focus on symptom relief
Detailed Description:
Up until 1975 the only treatment options for TMJ internal derangement were surgical procedures that involved either repositioning the articular disc or removing it Arthroscopic lavage was first described by Ohnishi as a way to dissolve adhesions and remove the inflammatory mediators which reduced the pain increased the mouth opening and increased the harmony between the mandibular condyle and the articular disc even though their native anatomical relation was not restored Nitzan et al in 1991 described arthrocentesis as a conservative method for TMJ lavage that discarded the arthroscopic morbidity and the need for costly tools and primarily aimed to utilize the hydraulic pressure of the lavage solution to wash out the inflammatory mediators and release the articular disc adhesions
The direct injection of a therapeutic agent into a joint cavity is known as intra-articular injection Which usually aims to relieve arthralgia suppress inflammation and enhance joint function
Various therapeutic agents are being deposited intra-articularly including corticosteroids hyaluronic acid platelet-rich plasma and fibrin opioids corticosteroids anxiolytics muscle relaxants antidepressants anticonvulsants and nonsteroidal anti-inflammatory drugs NSAIDs
NSAIDs the direct inhibition of the cyclooxygenase COX conversion of arachidonic acid to prostaglandins has been used to treat inflammatory articular diseases
Oxicam-derived Tenoxicam and Meloxicam are inexpensive and readily available NSAIDs frequently injected intraarticularly following knee arthroscopy and TMJ arthrocentesis by virtue of their sustained drug delivery and long-lasting inflammatory effect
Tenoxicam is a nonselective NSAID that inhibits both COX-1 and COX-2 On the other hand Meloxicam is a selective COX-2 inhibitor
The study aims to design a randomized controlled trial that compares the effect of intra-articular injection of the non-selective NSAID Tenoxicam versus the selective COX-2 inhibitor Meloxicam after arthrocentesis on alleviating the clinical signs and symptoms of TMJ disc displacement with reduction
The direct injection of a therapeutic agent into a joint cavity is known as intra-articular injection Which usually aims to relieve arthralgia suppress inflammation and enhance joint function
Various therapeutic agents are being deposited intra-articularly including corticosteroids hyaluronic acid platelet-rich plasma and fibrin opioids corticosteroids anxiolytics muscle relaxants antidepressants anticonvulsants and nonsteroidal anti-inflammatory drugs NSAIDs
NSAIDs the direct inhibition of the cyclooxygenase COX conversion of arachidonic acid to prostaglandins has been used to treat inflammatory articular diseases
Oxicam-derived Tenoxicam and Meloxicam are inexpensive and readily available NSAIDs frequently injected intraarticularly following knee arthroscopy and TMJ arthrocentesis by virtue of their sustained drug delivery and long-lasting inflammatory effect
Tenoxicam is a nonselective NSAID that inhibits both COX-1 and COX-2 On the other hand Meloxicam is a selective COX-2 inhibitor
The study aims to design a randomized controlled trial that compares the effect of intra-articular injection of the non-selective NSAID Tenoxicam versus the selective COX-2 inhibitor Meloxicam after arthrocentesis on alleviating the clinical signs and symptoms of TMJ disc displacement with reduction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None