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

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

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint; Anterior Disc Displacement; Ozonated Water Arthrocentesis; Conventional Arthrocentesis
• Intervention / Treatment: Procedure: Arthrocentesis using ozonized water; Procedure: Arthrocentesis using ringer's solution

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Patients were treated by Arthrocentesis using ozonized water.	Procedure: Arthrocentesis using ozonized water; Patients were treated by Arthrocentesis using ozonized water.
Active Comparator: Group II; Patients were treated using conventional arthrocentesis with ringer's solution.	Procedure: Arthrocentesis using ringer's solution; Patients were treated using conventional arthrocentesis with ringer's solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of pain	Each patient was instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable")	One week after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of maximum mouth opening	Maximal mouth opening which is the separation distance between the incisal edges of the mandibular and maxillary incisors was measured in millimeters	One week after surgery

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Actual): November 3, 2025
• Study Completion (Actual): November 3, 2025

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: FDASU-Rec IM122414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No