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

NCT07666282 — Not applicable, Completed, 30 participants, Ain Shams University

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

RegistryNCT07666282
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment30 (Actual)
SponsorAin Shams University (Other)
ConditionsOzonated Water Arthrocentesis, Conventional Arthrocentesis, Anterior Disc Displacement, Temporomandibular Joint
InterventionsArthrocentesis using ozonized water, Arthrocentesis using ringer's solution (Procedure)
Datesstart 2024-11-11, primary completion 2025-11-03, completion 2025-11-03, first posted 2026-06-24, last updated 2026-06-24
Locations1 site in Egypt

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-Summary

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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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Group IExperimentalProcedure: Arthrocentesis using ozonized waterPatients were treated by Arthrocentesis using ozonized water.
Group IIActive comparatorProcedure: Arthrocentesis using ringer's solutionPatients were treated using conventional arthrocentesis with ringer's solution.
  • 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.

+Outcome measures

Primary outcomes

  • Degree of pain [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

  • Measurement of maximum mouth opening [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

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Ain Shams UniversityCairoEgypt

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