COMPARISON BETWEEN DIFFERENT CONCENTRATIONS OF OZONE GAS AS AN INTRA-ARTICULAR INJECTION FOR TREATMENT OF INTERNAL DERANGEMENT OF TEMPROMANDIBULAR JOINT

COMPARISON BETWEEN DIFFERENT CONCENTRATIONS OF OZONE GAS AS AN INTRA-ARTICULAR INJECTION FOR TREATMENT OF INTERNAL DERANGEMENT OF TEMPROMANDIBULAR JOINT (A RANDOMIZED CONTROLLED CLINICAL TRIAL)

The intra-articular injection is considered the first line of minimally invasive treatment of joint disease as it has an analgesic, antimicrobial effect and an immune system stimulating action as it is one of the most powerful detoxication agents.

Study Overview

• Status: Completed
• Conditions: TMJ Disc Disorder
• Intervention / Treatment: Other: Patients will be treated with 2ml ozone oxygen mixture with concentration 10 micron/ml; Other: Patients will be treated with 2ml ozone oxygen mixture with concentration 5 micron/ml

Detailed Description

Aim of the study: This study aims to evaluate the therapeutic effect of intra-articular injection of two different concentrations of ozone gas in the treatment of internal derangement of TMJ.

A total of 20 patients suffering from internal derangement of TMJ will be included in the study. These patients will be randomly assigned to one of two groups. Group A will receive 2 ml ozone-oxygen gas mixture that will be injected intra-articularly with concentration 5 microns/ml (study group). Group B will receive 2ml intra articular ozone-oxygen gas injection with concentration 10 microns/ml (control group). Both groups will receive three sessions of intraarticular injection, one session per week. The first session will be arthrocentesis by ozonated water as a lavage then intraarticular injection with ozone-oxygen gas mixture. Then, the other two sessions will be intraarticular gas injection only. Assessment will be done by measuring the maximum mouth opening and by using Helkimo's index to measure the improvement of symptoms .The follow up period will be 1 month , 3 months and 6 months after the sessions.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria Governorate
    • Alexandria, Alexandria Governorate, Egypt, 21523
      • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Adult patients above 18 years old.
2. Patients suffering from sounds during condylar movements (clicking or popping).
3. Patients suffering from limited mouth opening and impaired joint movements.
4. Patients who did not respond to conservative treatment as a first line of treatment.

Exclusion Criteria:

1. Patients with history of condylar fracture.
2. Patients with degenerative joint disease.
3. Coagulopathy blood disorders.
4. Presence of infection at the site of injection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; Patients will be treated with 2ml ozone oxygen mixture with concentration 5 micron/ml	Other: Patients will be treated with 2ml ozone oxygen mixture with concentration 10 micron/ml; Patients will be treated with 2ml ozone oxygen mixture with concentration 10 micron/ml
Active Comparator: Control Group; Patients will be treated with 2ml ozone oxygen mixture with concentration 10 micron/ml	Other: Patients will be treated with 2ml ozone oxygen mixture with concentration 5 micron/ml; Patients will be treated with 2ml ozone oxygen mixture with concentration 5 micron/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helkimo's Index	Each patient was scored on a scale of 0-5 points. The total dysfunction index (Di) is calculated by summing the scores across all parameters, with the following classifications:	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Mouth Opening	Caliber measurement of Maximum Mouth Opening	6 months

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: yehia A El-Mahallawy, Phd, Faculty of Dentistry, Alexandria University, Alexandria, Alexandria

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: April 5, 2026
• First Submitted That Met QC Criteria: April 5, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Intra-articular injection; Ozonated water; Ozone gas,; Internal derangement of temporomandibular joint
• Other Study ID Numbers: Ozo-5-4-26

Drug and device information, study documents

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