Clinical Effectiveness of Combined Arthrocentesis With Intra-articular Injection of Meloxicam in Treatment of Temporomandibular Joint Internal Derangement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Arthrocentesis with ringer lactate solution and meloxicam injection, Arthrocentesis with ringer lactate solution.
- Who it may be relevant to
- Registry conditions: Temporomandibular Joint Internal Derangement. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iraq
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This randomized controlled clinical study is designed to evaluate the clinical effectiveness of combining temporomandibular joint (TMJ) arthrocentesis with a single intra-articular injection of meloxicam in patients suffering from TMJ internal derangement. Temporomandibular disorders (TMD) are common conditions causing pain, restricted jaw movement, and joint sounds, which can significantly impair patients' quality of life. While conventional treatments include conservative approaches and arthrocentesis alone, finding optimal therapeutic protocols remains crucial for refractory cases. A total of 50 adult patients diagnosed with unilateral TMJ internal derangement (with or without reduction) who have failed at least one month of conservative therapy will be enrolled and randomly allocated into two equal groups: Study Group: Will undergo joint arthrocentesis followed by a single intra-articular injection of meloxicam (15 mg / 1.5 mL). Control Group: Will undergo joint arthrocentesis alone using Ringer's lactate solution. Patients will be evaluated across a 12-week postoperative period (at 2, 4, 8, and 12 weeks) to assess primary and secondary outcomes, including pain intensity (measured via a Numerical Rating Scale), maximum mouth opening (inter-incisal distance in millimeters), joint sounds (clicking, popping, or crepitus), and overall patient satisfaction. The findings aim to establish whether adding an intra-articular non-steroidal anti-inflammatory drug (NSAID) enhances the therapeutic benefits of standard TMJ arthrocentesis.
Interventions
- Drug Arthrocentesis with ringer lactate solution and meloxicam injection
Intra-articular injection of 1ml of meloxical after TMJ arthrocentesis - Drug Arthrocentesis with ringer lactate solution
Arthrocentesis of the TMJ with ringer lactate only
Primary outcome measures
- Maximum Mouth Opening (MMO) [Time frame: Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)]
- Pain intensity [Time frame: Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)]
- Presence or Absence of Joint Sounds [Time frame: Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)]
Secondary outcome measures (1)
- Patient Satisfaction [Time frame: Recorded at the final 12-week follow-up.]
Eligibility criteria
Inclusion criteria
- Adult patients >= 18 years diagnosed clinically with unilateral TMJ internal derangement with or without reduction, based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
- Failure of conservative therapy (splint therapy, physiotherapy) for at least 1 month.
- Willing and able to provide written informed consent.
Exclusion criteria
- Patients with bilateral TMJ internal derangement.
- History of TMJ surgery or major trauma on the affected side.
- Presence of rheumatic disease.
- Severe degenerative joint disease.
- Active infection around the TMJ.
- Known bleeding disorders or patients on anticoagulant therapy.
- Pregnancy or lactation.
- Allergy to Meloxicam or its components.
- Received intra-articular injections (corticosteroids, hyaluronic acid) in the TMJ within at least 3 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Iraq · 1 center
- Al-Yarmook teaching hospital — Baghdad
Identifiers
NCT: NCT07743684 · 21925