Temporomandibular Joint Internal Derangement (ADWR)Phase 2NCT07487675
Evaluation of Intravenous Sodium Valproate on Interleukin-6 Levels in Patients With TMJ Disc Displacement
A Phase 2 study testing sodium valproate and TMJ Arthrocentesis in people with Temporomandibular Joint Internal Derangement (ADWR), run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate if adding the medication Sodium Valproate to a standard jaw procedure (arthrocentesis) can help reduce inflammation and improve healing in patients with certain jaw joint problems. Read more about this study
- Who is it for?
- Ages 17 to 35 years, women only
- Conditions the study is for
- Temporomandibular Joint Internal Derangement (ADWR)
- What is being tested?
- sodium valproate and TMJ Arthrocentesis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Sep 2024to 6 May 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 17 to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female patients between the ages of 17 and 35 years.
- Clinical and radiographic diagnosis (via MRI) of TMJ anterior disc displacement with reduction (ADDWR).
- Patients who failed to respond to conservative treatment (e.g., medication, splint therapy, or physical therapy) for more than three months.
- Presence of clinical symptoms including joint pain, clicking sounds, or limited mouth opening.
Who cannot join
- History of previous TMJ surgery or arthrocentesis.
- Presence of systemic inflammatory diseases or metabolic bone diseases (e.g., rheumatoid arthritis).
- Evidence of bony changes in the TMJ (e.g., osteoarthritis or ankylosis).
- patients with history of systemic immune disease
- Patients with TMJ neoplastic changes.
- Patients with history of recent facial trauma
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- Patients with high risk of hemorrhage
- Patients with prosthetic joint replacement
- Patients with allergic to any component of the injectable solution.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University
Tanta, Gharbia Governorate, 31773
About this study
Official title: Evaluation The Effects Of Intravenous Sodium Valproate On The Interleukin-6 Profile In Patients With The Temporomandibular Joint Anterior Disc Displacement With Reduction
This study aims to evaluate if adding the medication Sodium Valproate to a standard jaw procedure (arthrocentesis) can help reduce inflammation and improve healing in patients with certain jaw joint problems.
The jaw joint, known as the temporomandibular joint (TMJ), can sometimes become painful or "click" due to a condition called anterior disc displacement. A common treatment is arthrocentesis, which involves washing out the joint. In this study, researchers are testing whether injecting Sodium Valproate during this procedure reduces the levels of Interleukin-6 (IL-6), a specific protein that causes inflammation, more effectively than the procedure alone.
Participants will have their joint fluid tested before and after the treatment to see if the levels of this inflammatory protein have decreased.
Read the detailed description
This prospective clinical study evaluates the anti-inflammatory efficacy and clinical outcomes of intravenous (IV) sodium valproate administration combined with temporomandibular joint (TMJ) arthrocentesis. The study population consisted of 10 adult female patients (ages 17-35) diagnosed with anterior disc displacement with reduction (ADDR) who were non-responsive to conservative management for at least 3 months.
Procedure Methodology:
All participants received an intravenous injection of sodium valproate. Following the systemic administration, a conventional double-puncture arthrocentesis was performed under local anesthesia. The joint space was lavage with 100 ml of Ringer's lactate solution.
Outcome Assessment:
Biochemical Analysis: Synovial fluid samples were collected via the arthrocentesis needles both immediately before the lavage (baseline) and after the treatment intervention. These samples were analyzed using Enzyme-Linked Immunosorbent Assay (ELISA) to quantify changes in Interleukin-6 (IL-6) concentrations.
Clinical Evaluation: Pain intensity was measured using a Visual Analogue Scale (VAS). Mechanical function was assessed by measuring Maximal Mouth Opening (MMO) and recording the presence of joint clicking. These parameters were tracked at standardized intervals: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months and 1 year post-operatively.
Radiographic Imaging: Magnetic Resonance Imaging (MRI) was conducted at Pre-operative and post-operative 3 month ,6 month and 1 year marks to objectively evaluate disc position and the presence or resolution of joint effusion.
The study aims to provide clinical evidence of sodium valproate's role as an adjunctive therapy in modulating the inflammatory cascade associated with TMJ pathology.
- Being tested
- sodium valproate, TMJ Arthrocentesis
- Keywords
- Temporomandibular joint disorder, sodium valproate, interleukin-6, arthrocentesis, Anterior disc displacement with reduction, synovial fluid, inflammation
- Medical subject headings
- Temporomandibular Joint Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium valproateDrug
Intravenous (IV) administration of sodium valproate. This is used as an adjunctive systemic therapy to modulate the inflammatory cascade (specifically targeting IL-6 levels) in the temporomandibular joint anterior disc with reduction (ADDWR)
TMJ ArthrocentesisProcedure or surgery
Conventional double-puncture arthrocentesis technique performed under local anesthesia. The superior joint space is lavage with 100 ml of Ringer's lactate solution to remove inflammatory mediators and release the articular disc.
| Study group | Role | What they receive |
|---|---|---|
| IV Sodium Valproate + TMJ Arthrocentesis | Experimental | A single experimental group of 10 female patients (ages 17-35) diagnosed with TMJ internal derangement (ADDR). Each participant received a systemic intravenous dose of sodium valproate followed by conventional double-puncture arthrocentesis of the superior joint space with 100 ml Ringer's lactate lavage. Receives: Drug: sodium valproate; Procedure: TMJ Arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of Interleukin-6 (IL-6) in Synovial Fluid
Evaluation of the anti-inflammatory effect of systemic sodium valproate by measuring the changes in IL-6 levels. Synovial fluid samples were analyzed using the Enzyme-Linked Immunosorbent Assay (ELISA) technique.
Measured: Baseline (immediately pre-operative) and Post-operative (immediately followed by conventional double-puncture arthrocentesis with 100 ml Ringer's lactate lavage.
Secondary outcomes (1)
Pain Intensity measured by Visual Analogue Scale (VAS) Score
Patients self-reported pain levels on a scale from 0 (no pain) to 10 (worst imaginable pain).
Measured: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start29 Sep 2024
- Primary completion6 May 2025
- Study completion6 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Internal Derangement (ADWR)Studies of the same condition, open and under way.
- More trials run by Tanta 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roaa Hassan Jafar Al. Hassan, Tanta University
- Investigators
- Rafic Ramadan Beder, Ph.D., Study chair, Professor of Oral and Maxillofacial Surgery Faculty of Dentistry-Tanta UniversityAhmed A Mosleh, Ph.D., Study director, Lecturer of Oral and Maxillofacial Surgery Faculty of Dentistry-Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487675
- Sponsor's protocol ID
- OS-8-24-2245
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient privacy and clinical confidentiality. Only de-identified aggregate data presented in the final thesis and any resulting publications will be made available to the scientific community.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation The Effects Of Intravenous Sodium Valproate On The Interleukin-6 Profile In Patients With The Temporomandibular Joint Anterior Disc Displacement With Reduction
- ClinicalTrials.gov ID
- NCT07487675
- Acronym / sponsor ID
- OS-8-24-2245
- Keywords
- Temporomandibular joint disorder, sodium valproate, interleukin-6, arthrocentesis, Anterior disc displacement with reduction, synovial fluid, inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 29 Sep 2024 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 6 May 2026 (estimated)
- First posted
- 23 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.
This study aims to evaluate if adding the medication Sodium Valproate to a standard jaw procedure (arthrocentesis) can help reduce inflammation and improve healing in patients with certain jaw joint problems.
The jaw joint, known as the temporomandibular joint (TMJ), can sometimes become painful or "click" due to a condition called anterior disc displacement. A common treatment is arthrocentesis, which involves washing out the joint. In this study, researchers are testing whether injecting Sodium Valproate during this procedure reduces the levels of Interleukin-6 (IL-6), a specific protein that causes inflammation, more effectively than the procedure alone.
Participants will have their joint fluid tested before and after the treatment to see if the levels of this inflammatory protein have decreased.
Detailed description
This prospective clinical study evaluates the anti-inflammatory efficacy and clinical outcomes of intravenous (IV) sodium valproate administration combined with temporomandibular joint (TMJ) arthrocentesis. The study population consisted of 10 adult female patients (ages 17-35) diagnosed with anterior disc displacement with reduction (ADDR) who were non-responsive to conservative management for at least 3 months.
Procedure Methodology:
All participants received an intravenous injection of sodium valproate. Following the systemic administration, a conventional double-puncture arthrocentesis was performed under local anesthesia. The joint space was lavage with 100 ml of Ringer's lactate solution.
Outcome Assessment:
Biochemical Analysis: Synovial fluid samples were collected via the arthrocentesis needles both immediately before the lavage (baseline) and after the treatment intervention. These samples were analyzed using Enzyme-Linked Immunosorbent Assay (ELISA) to quantify changes in Interleukin-6 (IL-6) concentrations.
Clinical Evaluation: Pain intensity was measured using a Visual Analogue Scale (VAS). Mechanical function was assessed by measuring Maximal Mouth Opening (MMO) and recording the presence of joint clicking. These parameters were tracked at standardized intervals: 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months and 1 year post-operatively.
Radiographic Imaging: Magnetic Resonance Imaging (MRI) was conducted at Pre-operative and post-operative 3 month ,6 month and 1 year marks to objectively evaluate disc position and the presence or resolution of joint effusion.
The study aims to provide clinical evidence of sodium valproate's role as an adjunctive therapy in modulating the inflammatory cascade associated with TMJ pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV Sodium Valproate + TMJ Arthrocentesis | Experimental | Drug: sodium valproate, Procedure: TMJ ArthrocentesisA single experimental group of 10 female patients (ages 17-35) diagnosed with TMJ internal derangement (ADDR). Each participant received a systemic intravenous dose of sodium valproate followed by conventional double-puncture arthrocentesis of the superior joint space with 100 ml Ringer's lactate lavage. |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Female patients between the ages of 17 and 35 years.
- Clinical and radiographic diagnosis (via MRI) of TMJ anterior disc displacement with reduction (ADDWR).
- Patients who failed to respond to conservative treatment (e.g., medication, splint therapy, or physical therapy) for more than three months.
- Presence of clinical symptoms including joint pain, clicking sounds, or limited mouth opening.
Key exclusion criteria (9 listed)
- History of previous TMJ surgery or arthrocentesis.
- Presence of systemic inflammatory diseases or metabolic bone diseases (e.g., rheumatoid arthritis).
- Evidence of bony changes in the TMJ (e.g., osteoarthritis or ankylosis).
- patients with history of systemic immune disease
- Patients with TMJ neoplastic changes.
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 |
|---|---|---|
| sodium valproateIntravenous (IV) administration of sodium valproate. This is used as an adjunctive systemic therapy to modulate the inflammatory cascade (specifically targeting IL-6 levels) in the temporomandibular joint anterior disc with reduction (ADDWR) | Drug | IV Sodium Valproate + TMJ Arthrocentesis |
| TMJ ArthrocentesisConventional double-puncture arthrocentesis technique performed under local anesthesia. The superior joint space is lavage with 100 ml of Ringer's lactate solution to remove inflammatory mediators and release the articular disc. | Procedure or surgery | IV Sodium Valproate + TMJ Arthrocentesis |
Primary outcome
level of Interleukin-6 (IL-6) in Synovial Fluid
Time frame: Baseline (immediately pre-operative) and Post-operative (immediately followed by conventional double-puncture arthrocentesis with 100 ml Ringer's lactate lavage.
Evaluation of the anti-inflammatory effect of systemic sodium valproate by measuring the changes in IL-6 levels. Synovial fluid samples were analyzed using the Enzyme-Linked Immunosorbent Assay (ELISA) technique.
1 secondary outcome
Pain Intensity measured by Visual Analogue Scale (VAS) Score
Time frame: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year post-operatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Official website of the Faculty of Dentistry, Tanta University.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient privacy and clinical confidentiality. Only de-identified aggregate data presented in the final thesis and any resulting publications will be made available to the scientific community.
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.
Rafic Ramadan Beder, Ph.D. study chair
Professor of Oral and Maxillofacial Surgery Faculty of Dentistry-Tanta University
Ahmed A Mosleh, Ph.D. study director
Lecturer of Oral and Maxillofacial Surgery Faculty of Dentistry-Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sodium valproate and TMJ Arthrocentesis in people with Temporomandibular Joint Internal Derangement (ADWR), run by Tanta 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 9 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: under way, not looking for participants, as of the sponsor's last update on 23 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
level of Interleukin-6 (IL-6) in Synovial Fluid (time frame: Baseline (immediately pre-operative) and Post-operative (immediately followed by conventional double-puncture arthrocentesis with 100 ml Ringer's lactate lavage.). 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 23 Mar 2026.