Temporomandibular Joint Internal DerangementPhase 3NCT07463404
Clinical Evaluation of Arthrocentesis, Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor in Treatment of Temporo-Mandibular Joint Anterior Displacement
A Phase 3 study testing Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis in people with Temporomandibular Joint Internal Derangement, run by Suez Canal University at 1 site in Egypt.
Trial summary
Clinical Evaluation of Arthrocentesis, Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor in Treatment of Temporo-Mandibular Joint Anterior Displacement Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Temporomandibular Joint Internal Derangement
- What is being tested?
- Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 25 Nov 2025
- Phase
- Phase 3
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients aged from 18 to 40 years old.
- patients diagnosed with ID of TMJ, suffering from limited mandibular movements, joint pain and clicking.
- Patients who are free from any systemic disease and controlled systemic disease (ASA I) (ASA II).
- Patients willing to comply with the follow-up schedule and treatment protocol.
- both genders are included
Who cannot join
- Patients with systemic diseases (ASA III, IV, V).
- Patients who have myofascial pain dysfunction syndrome only.
- Patients who have previous surgery in TMJ.
- Patients who have previous arthrocentesis within 1 year.
- Patients who received previous trauma to the joint.
- Use of anticoagulants or immunosuppressive medications.
Trial locations and contacts
1 site in 1 country.
About this study
Clinical Evaluation of Arthrocentesis, Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor in Treatment of Temporo-Mandibular Joint Anterior Displacement
Read the detailed description
The internal derangement (ID) of the TMJ is an improper functional and positional connection between the articular components of the joint. It has been estimated that 80% of TMD patients have ID, which is typically classified into two classes: disc displacement with reduction and disc displacement without reduction.
The ID of the TMJ was often accompanied by the increased expression of COX-2 in both synovium and synovial fluid. This allows the accumulation of prostaglandins in synovial fluid, accompanied by peripheral Vaso permeability, that may lead to swollen synovium. Patients may become suffering from limited jaw motion and associated pain around the TMJ in this stage.
Arthrocentesis reduces the pain through removing the adherences, eliminates the negative pressure in the joint, washes the inflammatory mediators, distends the joint space, recovering the space of the joint disc and fossa, changes the viscosity of the synovial liquid.
Reducing discomfort, restoring normal mandibular motions, and enhancing patients' quality of life are all necessary components of effective treatment for arthrogenous TMDs.
Treatment of TMJ-ID with arthrocentesis, either alone or in conjunction with intraarticular injections, is quite successful. It enhances jaw motions, promotes mouth opening, and lessens discomfort. For intra-articular injections, hyaluronic acid, platelet-rich plasma, corticosteroids and non-steroidal anti-inflammatory medications (NSAIDS) are used.
- Being tested
- Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis
- Keywords
- temporomandibular joint internal derangement, Reducing discomfort, restoring normal mandibular motions, enhancing patients' quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesisCombination product
Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor meloxicam (Mobitil 15mg) after arthrocentesis
| Study group | Role | What they receive |
|---|---|---|
| patients with anterior disc displacement with reduction | Active comparator | 10 cases with anterior disc displacement with reduction were injected after arthrocentesis by combination of PRP and meloxicam (Mobitil 15mg). Receives: Combination Product: Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis |
| patients with anterior disc displacement without reduction | Active comparator | 10 cases with anterior disc displacement without reduction were injected after arthrocentesis by combination of PRP and meloxicam (Mobitil 15mg). Receives: Combination Product: Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mandibular Movements: measured in millimeters using a ruler or digital caliper.
Mandibular Movements: Including maximum mouth opening (MMO), right and left lateral movements, and protrusive movement, measured in millimeters using a ruler or digital caliper.
Measured: immediately, one, three and six months postoperatively
pain assessed by visual analogue scale
Pain: Assessed using a Visual Analogue Scale ranging from 0 to 10 over the TMJ area [ 0 is given when there is no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, 10 the worst pain].
Measured: preoperatively, one, three and six months postoperatively
Joint Clicking: Evaluated using a stethoscope and recorded as either present or absent.
Joint Clicking: Evaluated using a stethoscope and recorded as either present or absent.
Measured: immediately, one, three, six months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 Dec 2023
- Primary completion1 Jun 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Internal DerangementStudies of the same condition, open and under way.
- More trials run by Suez Canal 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study was conducted on adults between the age of 18-40 years old with temporomandibular joint internal derangement (20 cases) requiring arthrocentesis, the patients were divided to 10 cases with anterior disc displacement with reduction and 10 cases with anterior disc displacement without reduction, and the two groups will be injected after arthrocentesis by combination of PRP and Cyclooxygenase Enzyme-2 Inhibitor.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hossni elshahat hossni, postgraduate student, Principal investigator, Suez Canal UniversitySuez Canal University, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463404
- Sponsor's protocol ID
- Arthrocentesis of TMJ
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it is secret to patient
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Arthrocentesis, Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor in Treatment of Temporo-Mandibular Joint Anterior Displacement
- ClinicalTrials.gov ID
- NCT07463404
- Acronym / sponsor ID
- Arthrocentesis of TMJ
- Keywords
- temporomandibular joint internal derangement, Reducing discomfort, restoring normal mandibular motions, enhancing patients' quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 11 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.
Clinical Evaluation of Arthrocentesis, Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor in Treatment of Temporo-Mandibular Joint Anterior Displacement
Detailed description
The internal derangement (ID) of the TMJ is an improper functional and positional connection between the articular components of the joint. It has been estimated that 80% of TMD patients have ID, which is typically classified into two classes: disc displacement with reduction and disc displacement without reduction.
The ID of the TMJ was often accompanied by the increased expression of COX-2 in both synovium and synovial fluid. This allows the accumulation of prostaglandins in synovial fluid, accompanied by peripheral Vaso permeability, that may lead to swollen synovium. Patients may become suffering from limited jaw motion and associated pain around the TMJ in this stage.
Arthrocentesis reduces the pain through removing the adherences, eliminates the negative pressure in the joint, washes the inflammatory mediators, distends the joint space, recovering the space of the joint disc and fossa, changes the viscosity of the synovial liquid.
Reducing discomfort, restoring normal mandibular motions, and enhancing patients' quality of life are all necessary components of effective treatment for arthrogenous TMDs.
Treatment of TMJ-ID with arthrocentesis, either alone or in conjunction with intraarticular injections, is quite successful. It enhances jaw motions, promotes mouth opening, and lessens discomfort. For intra-articular injections, hyaluronic acid, platelet-rich plasma, corticosteroids and non-steroidal anti-inflammatory medications (NSAIDS) are used.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was conducted on adults between the age of 18-40 years old with temporomandibular joint internal derangement (20 cases) requiring arthrocentesis, the patients were divided to 10 cases with anterior disc displacement with reduction and 10 cases with anterior disc displacement without reduction, and the two groups will be injected after arthrocentesis by combination of PRP and Cyclooxygenase Enzyme-2 Inhibitor.
| Arm | Type | Receives |
|---|---|---|
| patients with anterior disc displacement with reduction | Active comparator | Combination Product: Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis10 cases with anterior disc displacement with reduction were injected after arthrocentesis by combination of PRP and meloxicam (Mobitil 15mg). |
| patients with anterior disc displacement without reduction | Active comparator | Combination Product: Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis10 cases with anterior disc displacement without reduction were injected after arthrocentesis by combination of PRP and meloxicam (Mobitil 15mg). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- patients aged from 18 to 40 years old.
- patients diagnosed with ID of TMJ, suffering from limited mandibular movements, joint pain and clicking.
- Patients who are free from any systemic disease and controlled systemic disease (ASA I) (ASA II).
- Patients willing to comply with the follow-up schedule and treatment protocol.
- both genders are included
Key exclusion criteria (6 listed)
- Patients with systemic diseases (ASA III, IV, V).
- Patients who have myofascial pain dysfunction syndrome only.
- Patients who have previous surgery in TMJ.
- Patients who have previous arthrocentesis within 1 year.
- Patients who received previous trauma to the joint.
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 |
|---|---|---|
| Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesisInject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor meloxicam (Mobitil 15mg) after arthrocentesis | Combination product | patients with anterior disc displacement with reduction, patients with anterior disc displacement without reduction |
Primary outcome
Mandibular Movements: measured in millimeters using a ruler or digital caliper.
Time frame: immediately, one, three and six months postoperatively
Mandibular Movements: Including maximum mouth opening (MMO), right and left lateral movements, and protrusive movement, measured in millimeters using a ruler or digital caliper.
pain assessed by visual analogue scale
Time frame: preoperatively, one, three and six months postoperatively
Pain: Assessed using a Visual Analogue Scale ranging from 0 to 10 over the TMJ area [ 0 is given when there is no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, 10 the worst pain].
Joint Clicking: Evaluated using a stethoscope and recorded as either present or absent.
Time frame: immediately, one, three, six months postoperatively
Joint Clicking: Evaluated using a stethoscope and recorded as either present or absent.
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 17 Mar 2026.
- Individual participant dataSharing planned: No. it is secret to patient
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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.
hossni elshahat hossni, postgraduate student principal investigator
Suez Canal University
Suez Canal University principal investigator
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inject Combination of Platelet-Rich Plasma and Cyclooxygenase Enzyme-2 Inhibitor after arthrocentesis in people with Temporomandibular Joint Internal Derangement, run by Suez Canal 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 17 Mar 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mandibular Movements: measured in millimeters using a ruler or digital caliper. (time frame: immediately, one, three and six months postoperatively). The study lists 3 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 17 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.