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NCT Number: NCT07743684

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

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.

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Key information

Conditions

Temporomandibular Joint Internal Derangement

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Al-Yarmook teaching hospital

Baghdad, Iraq

Location status: Recruiting

Location contact

Hussein Mohammed Ridha, B.D.S

CONTACT

[email protected]

009647706409168

Hussein Mohammed Ridha, B.D.S

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Arthrocentesis with ringer lactate solution and meloxicam injection

Drug

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

Arthrocentesis with ringer lactate solution

Drug

Arthrocentesis of the TMJ with ringer lactate only

Primary outcomes

  1. Maximum Mouth Opening (MMO)

    Time frame: 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.

  2. Pain intensity

    Time frame: 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.

  3. Presence or Absence of Joint Sounds

    Time frame: 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 outcomes

  1. Patient Satisfaction

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hussein Mohammed Ridha, B.D.S

CONTACT

[email protected]

009647706409168

Sponsors and collaborators

Lead sponsor

Hussein Mohammed Ridha

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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