TMJ Disc DisorderNCT07523451
Comparison Between Different Concentrations of Ozone Gas as an Intra-articular Injection for Treatment of Internal Derangement of Tempromandibular Joint
A study testing Patients will be treated with 2ml ozone oxygen mixture with concentration 6 micron/ml and Patients will be treated with 2ml ozone oxygen mixture with concentration 12 micron/ml in people with TMJ Disc Disorder, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TMJ Disc Disorder
- What is being tested?
- Patients will be treated with 2ml ozone oxygen mixture with concentration 6 micron/ml and Patients will be treated with 2ml ozone oxygen mixture with concentration 12 micron/ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with history of condylar fracture.
- Patients with degenerative joint disease.
- Coagulopathy blood disorders.
- Presence of infection at the site of injection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Alexandria University
Alexandria, Alexandria Governorate, 21523
About this study
Official 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)
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.
Read the 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.
- Conditions
- TMJ Disc Disorder
- Being tested
- 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
- Keywords
- Intra-articular injection, Ozone gas,, Internal derangement of temporomandibular joint, Ozonated water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will be treated with 2ml ozone oxygen mixture with concentration 6 micron/mlOther
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/mlOther
Patients will be treated with 2ml ozone oxygen mixture with concentration 12 micron/ml
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Patients will be treated with 2ml ozone oxygen mixture with concentration 6 micron/ml Receives: Other: Patients will be treated with 2ml ozone oxygen mixture with concentration 6 micron/ml |
| Control Group | Active comparator | Patients will be treated with 2ml ozone oxygen mixture with concentration 12 micron/ml Receives: Other: Patients will be treated with 2ml ozone oxygen mixture with concentration 12 micron/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
Measured: 6 months
Secondary outcomes (1)
Maximum Mouth Opening
Caliber measurement of Maximum Mouth Opening
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Feb 2025
- Primary completion30 Oct 2025
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ Disc DisorderStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yehia A El-Mahallawy, Phd, Principal investigator, Faculty of Dentistry, Alexandria University, Alexandria, Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523451
- Sponsor's protocol ID
- Ozo-5-4-26
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07523451
- Acronym / sponsor ID
- Ozo-5-4-26
- Conditions
- TMJ Disc Disorder
- Keywords
- Intra-articular injection, Ozone gas,, Internal derangement of temporomandibular joint, Ozonated water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Patients will be treated with 2ml ozone oxygen mixture with concentration 6 micron/mlPatients will be treated with 2ml ozone oxygen mixture with concentration 6 micron/ml |
| Control Group | Active comparator | Other: Patients will be treated with 2ml ozone oxygen mixture with concentration 12 micron/mlPatients will be treated with 2ml ozone oxygen mixture with concentration 12 micron/ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients with history of condylar fracture.
- Patients with degenerative joint disease.
- Coagulopathy blood disorders.
- Presence of infection at the site of injection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients will be treated with 2ml ozone oxygen mixture with concentration 6 micron/mlPatients will be treated with 2ml ozone oxygen mixture with concentration 6 micron/ml | Other | Study Group |
| Patients will be treated with 2ml ozone oxygen mixture with concentration 12 micron/mlPatients will be treated with 2ml ozone oxygen mixture with concentration 12 micron/ml | Other | Control Group |
Primary outcome
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:
1 secondary outcome
Maximum Mouth Opening
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yehia A El-Mahallawy, Phd principal investigator
Faculty of Dentistry, Alexandria University, Alexandria, Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients will be treated with 2ml ozone oxygen mixture with concentration 6 micron/ml and Patients will be treated with 2ml ozone oxygen mixture with concentration 12 micron/ml in people with TMJ Disc Disorder, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helkimo's Index (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.