Does Successive Intra-articular Injections of Tenoxicam or Meloxicam Affect Treatment of TMJ Displacement

NCT06403046 | Completed Phase 1

• 1 other identifier: 9
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The temporomandibular joint's (TMJ) articular disc, situated between the mandibular condyle's convexity and the articular tubercle's 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 o'clock position atop the mandibular condyle's 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.

Conditions

Temporomandibular Joint Disc Displacement, With Reduction

Outcome Measures

Primary Outcomes (3)

• Clicking

  Absence or presence of clicking

  9 months

• Visual analogue scale

  Scale from 1 to 10 which the 10 is the worst pain

  9 months

• Maximal interincisal opening

  Increase in interincisal opening

  9 months

Study Arms (2)

The Study group

EXPERIMENTAL

The study represents a randomized clinical trial that compares the short- and long-term effects of three repeated intraarticular injections of Tenoxicam post-arthrocentesis immediately, after one month, and two months after, with a one-month interval between each injection, for the alleviation of constitutional symptoms in patients with TMJ anterior disc displacement with reduction.

Drug: intraarticular injection

The Control group

EXPERIMENTAL

The study represents a randomized clinical trial that compares the short- and long-term effects of three repeated intraarticular injections of Meloxicam post-arthrocentesis immediately, after one month, and two months after, with a one-month interval between each injection, for the alleviation of constitutional symptoms in patients with TMJ anterior disc displacement with reduction.

Drug: intraarticular injection

Interventions

intraarticular injection DRUG

all patients will be subjected to routine (TMJ) arthrocentesis followed by Tenoxicam injection into the superior joint space in the (Tx group) and Meloxicam injection among the patients of (Mx group).

Also known as: arthrocentesis

The Control group; The Study group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both sexes with an age range of 18-45 years.
• Those patients with the radiographic interpretation of unilateral or bilateral (TMJ) anterior disc displacement with reduction with the clinical signs of pain, limitation of mouth opening, and TMJ clicking; Wilkes classification type II.

You may not qualify if:

• Clinical or radiographic signs of disc displacement without reduction, osteoarthritis, or articular bony changes.
• Previous (TMJ) surgery, arthrocentesis, or occlusal splints.
• Any systemic disease affecting the temporomandibular joint's anatomy, mechanical function, or outcome of the proposed treatment.
• Those Patients with a history of allergic reactions to any components of the injectable solutions.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-suef university

Banī Suwayf, Egypt

Location

MeSH Terms

Interventions

Injections, Intra-Articular; Arthrocentesis

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: An independent staff member will randomly allocate the patients into (Tx group) and (Mx group) after labeling them
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: two groups each groups consists of 15 participants \& the total number of participants is 30 as the patients are divided into (Tx group) and (Mx group) after labeling them in sequential numbers

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: June 1, 2024
• Primary Completion: May 7, 2025
• Study Completion: September 7, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)