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)

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07523451

Enrollment

Registered

2026-04-13

Start date

2025-02-01

Completion date

2026-04-01

Last updated

2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TMJ Disc Disorder

Keywords

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

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.

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 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.

Interventions

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

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

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Helkimo's Index	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

Measure	Time frame	Description
Maximum Mouth Opening	6 months	Caliber measurement of Maximum Mouth Opening

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORyehia A El-Mahallawy, Phd

Faculty of Dentistry, Alexandria University, Alexandria, Alexandria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026