Efficiency of Ozonated Water Arthrocentesis Versus Conventional Arthrocentesis in the Treatment of Anterior Disc Displacement With Reduction of the TMJ: Randomized Controlled Trial.
| Registry | NCT07666282 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 30 (Actual) |
| Sponsor | Ain Shams University (Other) |
| Conditions | Ozonated Water Arthrocentesis, Conventional Arthrocentesis, Anterior Disc Displacement, Temporomandibular Joint |
| Interventions | Arthrocentesis using ozonized water, Arthrocentesis using ringer's solution (Procedure) |
| Dates | start 2024-11-11, primary completion 2025-11-03, completion 2025-11-03, first posted 2026-06-24, last updated 2026-06-24 |
| Locations | 1 site in Egypt |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group I | Experimental | Procedure: Arthrocentesis using ozonized water | Patients were treated by Arthrocentesis using ozonized water. |
| Group II | Active comparator | Procedure: Arthrocentesis using ringer's solution | Patients were treated using conventional arthrocentesis with ringer's solution. |
Sex: All, ages: 18 Years to 65 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Ain Shams University | Cairo | Egypt |