Ozonated Water ArthrocentesisNCT07666282
Efficiency of Ozonated Water Arthrocentesis Versus Conventional Arthrocentesis in the Treatment of Anterior Disc Displacement With Reduction of the TMJ
A study testing Arthrocentesis using ozonized water and Arthrocentesis using ringer's solution in people with Ozonated Water Arthrocentesis and Conventional Arthrocentesis, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to clinically evaluate and compare the effectiveness of ozonized water arthrocentesis (lavage) and conventional Ringer's solution arthrocentesis in the management of temporomandibular joint (TMJ) anterior disc displacement with reduction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ozonated Water Arthrocentesis, Conventional Arthrocentesis, Anterior Disc Displacement
- What is being tested?
- Arthrocentesis using ozonized water and Arthrocentesis using ringer's solution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2024to 3 Nov 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 years, with no gender preference.
- A main temporomandibular joint (TMJ) complaint that is diagnosed as disc displacement with reduction and arthralgia according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
- Presence of unilateral or bilateral temporomandibular disorder.
- American Society of Anesthesiologists (ASA) class I and II patients who are fit for general anesthesia.
- No improvement with conservative treatment for 3 months.
- Free of magnetic resonance imaging (MRI) contraindications.
- No previous surgeries to the TMJ.
Who cannot join
- History of systemic diseases that affect the TMJ such as rheumatoid arthritis and osteoarthritis.
- Restricted mouth opening due to muscle spasm.
- Developmental or congenital TMJ disorders.
- Benign or malignant TMJ lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of Ozonated Water Arthrocentesis Versus Conventional Arthrocentesis in the Treatment of Anterior Disc Displacement With Reduction of the TMJ: Randomized Controlled Trial.
The aim of this study is to clinically evaluate and compare the effectiveness of ozonized water arthrocentesis (lavage) and conventional Ringer's solution arthrocentesis in the management of temporomandibular joint (TMJ) anterior disc displacement with reduction. The study seeks to determine whether the use of ozonized water as an irrigating solution during arthrocentesis provides superior clinical outcomes in terms of pain reduction, improvement of mandibular function, and enhancement of mouth opening compared with conventional arthrocentesis performed using Ringer's solution.
Read the detailed description
A large number of people worldwide suffer from temporomandibular joint internal derangement (TMJ ID), with women accounting for the majority of affected individuals.
Various treatment modalities have been proposed to restore functional equilibrium of the TMJ system. Management typically begins with conservative approaches, such as dietary modifications, antidepressant medications, non-steroidal anti-inflammatory drugs (NSAIDs), physiotherapy, and occlusal splints. When conservative measures fail to provide adequate symptom relief, minimally invasive interventions may be considered, including acupuncture, intra-articular injections of morphine or corticosteroids, botulinum toxin injection, and arthrocentesis. More advanced cases may require invasive surgical procedures such as arthroscopy or open joint surgery.
- Conditions
- Ozonated Water Arthrocentesis, Conventional Arthrocentesis, Anterior Disc Displacement, Temporomandibular Joint
- Being tested
- Arthrocentesis using ozonized water, Arthrocentesis using ringer's solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrocentesis using ozonized waterProcedure or surgery
Patients were treated by Arthrocentesis using ozonized water.
Arthrocentesis using ringer's solutionProcedure or surgery
Patients were treated using conventional arthrocentesis with ringer's solution.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients were treated by Arthrocentesis using ozonized water. Receives: Procedure: Arthrocentesis using ozonized water |
| Group II | Active comparator | Patients were treated using conventional arthrocentesis with ringer's solution. Receives: Procedure: Arthrocentesis using ringer's solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
Each patient was instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable")
Measured: One week after surgery
Secondary outcomes (1)
Measurement of maximum mouth opening
Maximal mouth opening which is the separation distance between the incisal edges of the mandibular and maxillary incisors was measured in millimeters
Measured: One week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start11 Nov 2024
- Primary completion3 Nov 2025
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ozonated Water ArthrocentesisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NAWAR MOHAMMAD ALKHALIFA, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666282
- Sponsor's protocol ID
- FDASU-Rec IM122414
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Ozonated Water Arthrocentesis Versus Conventional Arthrocentesis in the Treatment of Anterior Disc Displacement With Reduction of the TMJ: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07666282
- Acronym / sponsor ID
- FDASU-Rec IM122414
- Conditions
- Ozonated Water Arthrocentesis, Conventional Arthrocentesis, Anterior Disc Displacement, Temporomandibular Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 3 Nov 2025 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 24 Jun 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 aim of this study is to clinically evaluate and compare the effectiveness of ozonized water arthrocentesis (lavage) and conventional Ringer's solution arthrocentesis in the management of temporomandibular joint (TMJ) anterior disc displacement with reduction. The study seeks to determine whether the use of ozonized water as an irrigating solution during arthrocentesis provides superior clinical outcomes in terms of pain reduction, improvement of mandibular function, and enhancement of mouth opening compared with conventional arthrocentesis performed using Ringer's solution.
Detailed description
A large number of people worldwide suffer from temporomandibular joint internal derangement (TMJ ID), with women accounting for the majority of affected individuals.
Various treatment modalities have been proposed to restore functional equilibrium of the TMJ system. Management typically begins with conservative approaches, such as dietary modifications, antidepressant medications, non-steroidal anti-inflammatory drugs (NSAIDs), physiotherapy, and occlusal splints. When conservative measures fail to provide adequate symptom relief, minimally invasive interventions may be considered, including acupuncture, intra-articular injections of morphine or corticosteroids, botulinum toxin injection, and arthrocentesis. More advanced cases may require invasive surgical procedures such as arthroscopy or open joint surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Procedure: Arthrocentesis using ozonized waterPatients were treated by Arthrocentesis using ozonized water. |
| Group II | Active comparator | Procedure: Arthrocentesis using ringer's solutionPatients were treated using conventional arthrocentesis with ringer's solution. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18-65 years, with no gender preference.
- A main temporomandibular joint (TMJ) complaint that is diagnosed as disc displacement with reduction and arthralgia according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
- Presence of unilateral or bilateral temporomandibular disorder.
- American Society of Anesthesiologists (ASA) class I and II patients who are fit for general anesthesia.
- No improvement with conservative treatment for 3 months.
Key exclusion criteria (4 listed)
- History of systemic diseases that affect the TMJ such as rheumatoid arthritis and osteoarthritis.
- Restricted mouth opening due to muscle spasm.
- Developmental or congenital TMJ disorders.
- Benign or malignant TMJ lesions.
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 |
|---|---|---|
| Arthrocentesis using ozonized waterPatients were treated by Arthrocentesis using ozonized water. | Procedure or surgery | Group I |
| Arthrocentesis using ringer's solutionPatients were treated using conventional arthrocentesis with ringer's solution. | Procedure or surgery | Group II |
Primary outcome
Degree of pain
Time frame: One week after surgery
Each patient was instructed about postoperative pain assessment with VAS. VAS (0 represents "no pain" while 10 represents "the worst pain imaginable")
1 secondary outcome
Measurement of maximum mouth opening
Time frame: One week after surgery
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 24 Jun 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrocentesis using ozonized water and Arthrocentesis using ringer's solution in people with Ozonated Water Arthrocentesis and Conventional Arthrocentesis, run by Ain Shams 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 7 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 24 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?
Degree of pain (time frame: One week after surgery). 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 24 Jun 2026.