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

March 13, 2026 updated by: Suez Canal University
Clinical Evaluation of Arthrocentesis, Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor in Treatment of Temporo-Mandibular Joint Anterior Displacement

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Ismailia, Egypt
        • Faculty of Dentistry Suez Canal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: patients with anterior disc displacement with reduction
10 cases with anterior disc displacement with reduction were injected after arthrocentesis by combination of PRP and meloxicam (Mobitil 15mg).
Combination product: Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis
Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor meloxicam (Mobitil 15mg) after arthrocentesis
Active Comparator: patients with anterior disc displacement without reduction
10 cases with anterior disc displacement without reduction were injected after arthrocentesis by combination of PRP and meloxicam (Mobitil 15mg).
Combination product: Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis
Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor meloxicam (Mobitil 15mg) after arthrocentesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
immediately, one, three and six months postoperatively
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.
immediately, one, three, six months postoperatively
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].
preoperatively, one, three and six months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Investigators

  • Principal Investigator: hossni elshahat hossni, postgraduate student, Suez Canal University
  • Principal Investigator: Suez Canal University, Suez Canal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

November 25, 2025

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Arthrocentesis of TMJ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

it is secret to patient

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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