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Completed

NCT Number: NCT07523451

Comparison Between Different Concentrations of Ozone Gas as an Intra-articular Injection for Treatment of Internal Derangement of Tempromandibular Joint

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Alexandria Governorate, 21523, Egypt

About this study

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 6 microns/ml (study group). Group B will receive 2ml intra articular ozone-oxygen gas injection with concentration 12 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Patients will be treated with 2ml ozone oxygen mixture with concentration 6 micron/ml

Other

Patients will be treated with 2ml ozone oxygen mixture with concentration 6 micron/ml

Patients will be treated with 2ml ozone oxygen mixture with concentration 12 micron/ml

Other

Patients will be treated with 2ml ozone oxygen mixture with concentration 12 micron/ml

Primary outcomes

  1. Helkimo's Index

    Time frame: 6 months

    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:

Secondary outcomes

  1. Maximum Mouth Opening

    Time frame: 6 months

    Caliber measurement of Maximum Mouth Opening

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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