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Completed

NCT Number: NCT07463404

Clinical Evaluation of Arthrocentesis, Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor in Treatment of Temporo-Mandibular Joint Anterior Displacement

Clinical Evaluation of Arthrocentesis, Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor in Treatment of Temporo-Mandibular Joint Anterior Displacement

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

faculty of dentistry Suez Canal university

Ismailia, Egypt

About this study

The internal derangement (ID) of the TMJ is an improper functional and positional connection between the articular components of the joint. It has been estimated that 80% of TMD patients have ID, which is typically classified into two classes: disc displacement with reduction and disc displacement without reduction.

The ID of the TMJ was often accompanied by the increased expression of COX-2 in both synovium and synovial fluid. This allows the accumulation of prostaglandins in synovial fluid, accompanied by peripheral Vaso permeability, that may lead to swollen synovium. Patients may become suffering from limited jaw motion and associated pain around the TMJ in this stage.

Arthrocentesis reduces the pain through removing the adherences, eliminates the negative pressure in the joint, washes the inflammatory mediators, distends the joint space, recovering the space of the joint disc and fossa, changes the viscosity of the synovial liquid.

Reducing discomfort, restoring normal mandibular motions, and enhancing patients' quality of life are all necessary components of effective treatment for arthrogenous TMDs.

Treatment of TMJ-ID with arthrocentesis, either alone or in conjunction with intraarticular injections, is quite successful. It enhances jaw motions, promotes mouth opening, and lessens discomfort. For intra-articular injections, hyaluronic acid, platelet-rich plasma, corticosteroids and non-steroidal anti-inflammatory medications (NSAIDS) are used.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients aged from 18 to 40 years old.
  • patients diagnosed with ID of TMJ, suffering from limited mandibular movements, joint pain and clicking.
  • Patients who are free from any systemic disease and controlled systemic disease (ASA I) (ASA II).
  • Patients willing to comply with the follow-up schedule and treatment protocol.
  • both genders are included

Exclusion criteria

  • Patients with systemic diseases (ASA III, IV, V).
  • Patients who have myofascial pain dysfunction syndrome only.
  • Patients who have previous surgery in TMJ.
  • Patients who have previous arthrocentesis within 1 year.
  • Patients who received previous trauma to the joint.
  • Use of anticoagulants or immunosuppressive medications.

Treatment and study plan

Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis

Combination Product

Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor meloxicam (Mobitil 15mg) after arthrocentesis

Primary outcomes

  1. Mandibular Movements: measured in millimeters using a ruler or digital caliper.

    Time frame: immediately, one, three and six months postoperatively

    Mandibular Movements: Including maximum mouth opening (MMO), right and left lateral movements, and protrusive movement, measured in millimeters using a ruler or digital caliper.

  2. pain assessed by visual analogue scale

    Time frame: preoperatively, one, three and six months postoperatively

    Pain: Assessed using a Visual Analogue Scale ranging from 0 to 10 over the TMJ area [ 0 is given when there is no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, 10 the worst pain].

  3. Joint Clicking: Evaluated using a stethoscope and recorded as either present or absent.

    Time frame: immediately, one, three, six months postoperatively

    Joint Clicking: Evaluated using a stethoscope and recorded as either present or absent.

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2026
Registry last updated
Mar 17, 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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