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

NCT07743684 | Recruiting

• 1 other identifier: 21925
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Internal Derangement

Outcome Measures

Primary Outcomes (3)

• Maximum Mouth Opening (MMO)

  Inter-incisal distance measured in millimeters using a digital caliper or standard ruler.

  Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)

• Pain intensity

  Measured using a 0-10 pain numerical rating scale (NRS), where 0 equals no pain and 10 equals the worst pain possible.

  Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)

• Presence or Absence of Joint Sounds

  Clinical examination evaluating the TMJ for joint sounds such as clicking, popping noise, or crepitus.

  Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)

Secondary Outcomes (1)

• Patient Satisfaction

  Recorded at the final 12-week follow-up.

Study Arms (2)

Meloxicam

ACTIVE COMPARATOR

Arthrocentesis with ringer lactate solution and meloxicam injection

Drug: Arthrocentesis with ringer lactate solution and meloxicam injection

Control

SHAM COMPARATOR

Arthrocentesis with ringer lactate solution only

Drug: Arthrocentesis with ringer lactate solution

Interventions

Arthrocentesis with ringer lactate solution DRUG

Arthrocentesis of the TMJ with ringer lactate only

Control

Arthrocentesis with ringer lactate solution and meloxicam injection DRUG

Intra-articular injection of 1ml of meloxical after TMJ arthrocentesis

Meloxicam

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hussein Mohammed Ridha: lead

Study Sites (1)

Al-Yarmook teaching hospital

Baghdad, Iraq

RECRUITING

MeSH Terms

Interventions

Arthrocentesis; Meloxicam

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Salwan Yousif Bede, B.D.S, F.I.B.M.S

  Iraqi board for medical specialities

  STUDY DIRECTOR

Central Study Contacts

Hussein Mohammed Ridha, B.D.S

CONTACT

009647706409168; hussein.mohammad@rocketmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Iraqi board Oral and Maxillofacial resident

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)