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

NCT07666282 | Completed

• 1 other identifier: FDASU-Rec IM122414
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Conventional Arthrocentesis; Anterior Disc Displacement; Temporomandibular Joint; Ozonated Water Arthrocentesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Measurement of maximum mouth opening

  One week after surgery

Study Arms (2)

Group I

EXPERIMENTAL

Patients were treated by Arthrocentesis using ozonized water.

Procedure: Arthrocentesis using ozonized water

Group II

ACTIVE COMPARATOR

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

Procedure: Arthrocentesis using ringer's solution

Interventions

Arthrocentesis using ringer's solution PROCEDURE

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

Group II

Arthrocentesis using ozonized water PROCEDURE

Patients were treated by Arthrocentesis using ozonized water.

Group I

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B.D.S of Oral and Maxillofacial Surgery, Faculty of Oral and Maxillofacial Surgery, Ain Shams University, Cairo, Egypt

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start: November 11, 2024
• Primary Completion: November 3, 2025
• Study Completion: November 3, 2025
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)