Efficiency of Ozonated Water Arthrocentesis Versus Conven... | NCT07666282

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

NCT07666282

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jun 24, 2026Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Ozonated Water Arthrocentesis
Conventional Arthrocentesis
Anterior Disc Displacement
Temporomandibular Joint

Interventions

Arthrocentesis using ozonized water
Arthrocentesis using ringer's solution

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 11, 2024Actual

Primary Completion Date

Nov 3, 2025Actual

Completion Date

Nov 3, 2025Actual

First Submitted Date

Jun 18, 2026

First Submission Date that Met QC Criteria

Jun 18, 2026

First Posted Date

Jun 24, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2026

Last Update Posted Date

Jun 24, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

NAWAR MOHAMMAD ALKHALIFA, B.D.S of Oral and Maxillofacial Surgery, Faculty of Oral and Maxillofacial Surgery, Ain Shams University, Cairo, Egypt, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Arthrocentesis using ozonized water	Procedure	Patients were treated by Arthrocentesis using ozonized water.	Group I

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain Shams University		Cairo		11591	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Types

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.

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.