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Clinical Effectiveness of Combined Arthrocentesis With Intra-articular Injection of Meloxicam in Treatment of Temporomandibular Joint Internal Derangement

NCT07743684 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-06

No results posted yet for this study

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.

Conditions

  • Temporomandibular Joint Internal Derangement

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

Sponsors & Collaborators

  • Hussein Mohammed Ridha

    lead OTHER

Principal Investigators

  • Salwan Yousif Bede, B.D.S, F.I.B.M.S · Iraqi board for medical specialities

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-04-30
Completion
2027-10-31

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07743684 on ClinicalTrials.gov