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

NCT07523451 | Completed

• 1 other identifier: Ozo-5-4-26
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

TMJ Disc Disorder

Keywords

Intra-articular injection; Ozone gas,; Internal derangement of temporomandibular joint; Ozonated water

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Maximum Mouth Opening

  6 months

Study Arms (2)

Study Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

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 5 micron/ml

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 10 micron/ml

Study Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Patients with history of condylar fracture.
• Patients with degenerative joint disease.
• Coagulopathy blood disorders.
• Presence of infection at the site of injection.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

Location

Study Officials

• yehia A El-Mahallawy, Phd

  Faculty of Dentistry, Alexandria University, Alexandria, Alexandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 13, 2026
• Study Start: February 1, 2025
• Primary Completion: October 30, 2025
• Study Completion: April 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

EG (1)