Temporomandibular Joint Internal Derangement
Conditions
Brief summary
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
DRUGArthrocentesis with ringer lactate solution and meloxicam injection
Intra-articular injection of 1ml of meloxical after TMJ arthrocentesis
DRUGArthrocentesis with ringer lactate solution
Arthrocentesis of the TMJ with ringer lactate only
Sponsors
Hussein Mohammed Ridha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Mouth Opening (MMO) | Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks) | Inter-incisal distance measured in millimeters using a digital caliper or standard ruler. |
| Pain intensity | Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks) | Measured using a 0-10 pain numerical rating scale , where 0 equals no pain and 10 equals the worst pain possible. The score indicates the degree of pain experienced by the patient by the patient at the baseline evaluation. Minimum score is 0, and the maximum score is 10. During the follow-up visits , decreasing pain score indicates better outcome, while increasing pain score indicates worse outcome. |
| Presence or Absence of Joint Sounds | Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks) | Clinical examination evaluating the TMJ for joint sounds such as clicking, popping noise, or crepitus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | Recorded at the final 12-week follow-up. | Patient Satisfaction evaluated using the 5-point Likert-like scale ranging from the minimum score: 1 (very dissatisfied) to the maximum score: 5 (very satisfied), where higher scores indicate a better outcome. |
Countries
Iraq
Contacts
STUDY_DIRECTORSalwan Yousif Bede, B.D.S, F.I.B.M.S
Iraqi board for medical specialities
Outcome results
None listed