TMJ Disc DisorderNCT07452289
Arthrocentesis of Temporomandibular Joint Using Ozonated Water Alongside With Platelet Rich Plasma Injection in Management of Anterior Disc Displacement Without Reduction:
A study testing Ozonated water and PRP injection and Ozonated water in people with TMJ Disc Disorder, run by Alexandria University at 1 site in Egypt.
Trial summary
Background: The temporomandibular joint (TMJ) is a highly intricate and complex synovial joint found in the human body. When TMJ dysfunction occurs, it causes pain and difficulties in opening the mouth, significantly impacting the patient's quality of life. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- TMJ Disc Disorder
- What is being tested?
- Ozonated water and PRP injection and Ozonated water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jul 2024to 15 May 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pain located in the affected TMJ, especially during opening.
- Joint noises.
- Limited mouth opening (less than 35 mm).
- Impeded lateral movement.
- Patient who did not respond to conservative management.
Who cannot join
- Patients receiving anticoagulation treatment or non-steroidal anti-inflammatory drugs within 48 hours preoperatively, corticosteroid injection at the treatment site within 1 month, or systemic use of corticosteroids within 2 weeks.
- Patients suffering from any systemic inflammatory (degenerative) joint disease, and bleeding disorders such as coagulation disorders, platelet disorders, vascular disorders, and fibrinolytic defects.
- Patients with overlying infection or cellulitis in preauricular region.
- Patients with condylar pathology (hypoplasia, hyperplasia or tumor).
- Patients with previous open TMJ surgery or previous joint fracture.
- Patients with normal disc positions as seen by the MRI and the limitation is due to another extraarticular cause such as zygomatic arch fracture or elongated coronoid process.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: Arthrocentesis of Temporomandibular Joint Using Ozonated Water Alongside With Platelet Rich Plasma Injection in Management of Anterior Disc Displacement Without Reduction: (Randomized Controlled Clinical Trial)
Background: The temporomandibular joint (TMJ) is a highly intricate and complex synovial joint found in the human body. When TMJ dysfunction occurs, it causes pain and difficulties in opening the mouth, significantly impacting the patient's quality of life. Internal derangements, characterized by the gradual displacement of the articular disc, stand out as the most prevalent intra-articular temporomandibular disorders. Temporomandibular joint arthrocentesis, a procedure utilizing different irrigating solutions, is acknowledged as an efficient therapy for managing internal derangements of the TMJ. Recently, ozone therapy and orthobiologics like Platelet rich plasma (PRP) have been attracting increasing attention worldwide due to their promising medical applications and diverse therapeutic benefits in management of joint dysfunctions.
Aim of this study: The aim of the study is to compare the effectiveness of temporomandibular joint arthrocentesis using ozonated water combined with platelet-rich plasma (PRP) injection versus ozonated water alone for treating Wilkes stages III and IV of anterior disc displacement in terms of pain score, maximum mouth opening, and range of motion. Additionally, the study aims to compare the impact of both treatments on the concentration of the proinflammatory cytokine interleukin-6 (IL-6) in the joint space.
- Conditions
- TMJ Disc Disorder
- Being tested
- Ozonated water and PRP injection, Ozonated water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozonated water and PRP injectionOther
patients will undergo arthrocentesis using ozonated water alongside PRP injection
Ozonated waterOther
patients will undergo arthrocentesis using ozonated water alone.
| Study group | Role | What they receive |
|---|---|---|
| Study ozonated group | Experimental | Not described Receives: Other: Ozonated water and PRP injection |
| Control group | Active comparator | Not described Receives: Other: Ozonated water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum mouth opening
mouth opening will be measured as the maximal distance between the cutting edge of the maxillary and mandibular central incisors using a millimeter ruler in the superioinferior direction.
Measured: up to 6 months
change in level of IL-6
synovial fluid samples will be collected to detect the level of IL-6
Measured: up to 6 months
Secondary outcomes (2)
change in lateral mandibular movement
The range of lateral mandibular movement will be measured after moving the mandible as far as possible to the right, and then to the left, starting from the mandibular rest position. Then, the distance between the lower and upper central incisor lines will be measured in the mediolateral direction
Measured: up to 6 months
change in protrusive movement
The range of protrusive movement will be measured after protruding the mandible as far as possible from the rest position. Then, the distance between the labial surface of the upper and lower incisors in the anteroposterior direction will be measured.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start2 Jul 2024
- Primary completion15 May 2025
- Study completion15 May 2025
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452289
- Sponsor's protocol ID
- 0932-06/2024
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthrocentesis of Temporomandibular Joint Using Ozonated Water Alongside With Platelet Rich Plasma Injection in Management of Anterior Disc Displacement Without Reduction: (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07452289
- Acronym / sponsor ID
- 0932-06/2024
- Conditions
- TMJ Disc Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 5 Mar 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.
Background: The temporomandibular joint (TMJ) is a highly intricate and complex synovial joint found in the human body. When TMJ dysfunction occurs, it causes pain and difficulties in opening the mouth, significantly impacting the patient's quality of life. Internal derangements, characterized by the gradual displacement of the articular disc, stand out as the most prevalent intra-articular temporomandibular disorders. Temporomandibular joint arthrocentesis, a procedure utilizing different irrigating solutions, is acknowledged as an efficient therapy for managing internal derangements of the TMJ. Recently, ozone therapy and orthobiologics like Platelet rich plasma (PRP) have been attracting increasing attention worldwide due to their promising medical applications and diverse therapeutic benefits in management of joint dysfunctions.
Aim of this study: The aim of the study is to compare the effectiveness of temporomandibular joint arthrocentesis using ozonated water combined with platelet-rich plasma (PRP) injection versus ozonated water alone for treating Wilkes stages III and IV of anterior disc displacement in terms of pain score, maximum mouth opening, and range of motion. Additionally, the study aims to compare the impact of both treatments on the concentration of the proinflammatory cytokine interleukin-6 (IL-6) in the joint space.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study ozonated group | Experimental | Other: Ozonated water and PRP injection |
| Control group | Active comparator | Other: Ozonated water |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Pain located in the affected TMJ, especially during opening.
- Joint noises.
- Limited mouth opening (less than 35 mm).
- Impeded lateral movement.
- Patient who did not respond to conservative management.
Key exclusion criteria (6 listed)
- Patients receiving anticoagulation treatment or non-steroidal anti-inflammatory drugs within 48 hours preoperatively, corticosteroid injection at the treatment site within 1 month, or systemic use of corticosteroids within 2 weeks.
- Patients suffering from any systemic inflammatory (degenerative) joint disease, and bleeding disorders such as coagulation disorders, platelet disorders, vascular disorders, and fibrinolytic defects.
- Patients with overlying infection or cellulitis in preauricular region.
- Patients with condylar pathology (hypoplasia, hyperplasia or tumor).
- Patients with previous open TMJ surgery or previous joint fracture.
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 |
|---|---|---|
| Ozonated water and PRP injectionpatients will undergo arthrocentesis using ozonated water alongside PRP injection | Other | Study ozonated group |
| Ozonated waterpatients will undergo arthrocentesis using ozonated water alone. | Other | Control group |
Primary outcome
Change in maximum mouth opening
Time frame: up to 6 months
mouth opening will be measured as the maximal distance between the cutting edge of the maxillary and mandibular central incisors using a millimeter ruler in the superioinferior direction.
change in level of IL-6
Time frame: up to 6 months
synovial fluid samples will be collected to detect the level of IL-6
2 secondary outcomes
change in lateral mandibular movement
Time frame: up to 6 months
change in protrusive movement
Time frame: up to 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 Sep 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.
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 Ozonated water and PRP injection and Ozonated water 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 5 inclusion and 6 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 Sep 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?
Change in maximum mouth opening (time frame: up to 6 months). The study lists 2 primary outcomes in all. 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 Sep 2026.