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Completed

NCT Number: NCT07666282

Efficiency of Ozonated Water Arthrocentesis Versus Conventional Arthrocentesis in the Treatment of Anterior Disc Displacement With Reduction of the TMJ

The aim of this study is to clinically evaluate and compare the effectiveness of ozonized water arthrocentesis (lavage) and conventional Ringer's solution arthrocentesis in the management of temporomandibular joint (TMJ) anterior disc displacement with reduction. The study seeks to determine whether the use of ozonized water as an irrigating solution during arthrocentesis provides superior clinical outcomes in terms of pain reduction, improvement of mandibular function, and enhancement of mouth opening compared with conventional arthrocentesis performed using Ringer's solution.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 11591, Egypt

About this study

A large number of people worldwide suffer from temporomandibular joint internal derangement (TMJ ID), with women accounting for the majority of affected individuals.

Various treatment modalities have been proposed to restore functional equilibrium of the TMJ system. Management typically begins with conservative approaches, such as dietary modifications, antidepressant medications, non-steroidal anti-inflammatory drugs (NSAIDs), physiotherapy, and occlusal splints. When conservative measures fail to provide adequate symptom relief, minimally invasive interventions may be considered, including acupuncture, intra-articular injections of morphine or corticosteroids, botulinum toxin injection, and arthrocentesis. More advanced cases may require invasive surgical procedures such as arthroscopy or open joint surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 18-65 years, with no gender preference.
  • A main temporomandibular joint (TMJ) complaint that is diagnosed as disc displacement with reduction and arthralgia according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
  • Presence of unilateral or bilateral temporomandibular disorder.
  • American Society of Anesthesiologists (ASA) class I and II patients who are fit for general anesthesia.
  • No improvement with conservative treatment for 3 months.
  • Free of magnetic resonance imaging (MRI) contraindications.
  • No previous surgeries to the TMJ.

Exclusion criteria

  • History of systemic diseases that affect the TMJ such as rheumatoid arthritis and osteoarthritis.
  • Restricted mouth opening due to muscle spasm.
  • Developmental or congenital TMJ disorders.
  • Benign or malignant TMJ lesions.

Treatment and study plan

Arthrocentesis using ozonized water

Procedure

Patients were treated by Arthrocentesis using ozonized water.

Arthrocentesis using ringer's solution

Procedure

Patients were treated using conventional arthrocentesis with ringer's solution.

Primary outcomes

  1. Degree of pain

    Time frame: One week after surgery

    Each patient was instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable")

Secondary outcomes

  1. Measurement of maximum mouth opening

    Time frame: One week after surgery

    Maximal mouth opening which is the separation distance between the incisal edges of the mandibular and maxillary incisors was measured in millimeters

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Efficiency of Ozonated Water Arthrocentesis Versus Conventional Arthrocentesis in the Treatment of Anterior Disc Displacement With Reduction of the TMJ: Randomized Controlled Trial.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2026
Registry last updated
Jun 24, 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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