Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University
Tanta, Gharbia Governorate, 31773, Egypt
NCT Number: NCT07487675
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.
This study is active but is not currently recruiting participants.
Notify Me17 year–35 year
Female
Interventional
Phase 2
Tanta, Gharbia Governorate, 31773, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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.
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.
Time frame: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year post-operatively.
Patients self-reported pain levels on a scale from 0 (no pain) to 10 (worst imaginable pain).
Time frame: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year post-operatively.
Measured as the distance (digital caliper) between the incisal edges of the upper and lower central incisors during maximum comfortable opening.
Time frame: Baseline, 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year post-operatively.
Clinical evaluation of the presence or absence of clicking sounds during jaw movement.
Time frame: 6 months and 1 year post-operatively.
Using MRI to assess the resolution of joint effusion and the stability of the disc position following treatment.
Tanta University
Other
Evaluation The Effects Of Intravenous Sodium Valproate On The Interleukin-6 Profile In Patients With The Temporomandibular Joint Anterior Disc Displacement With Reduction
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05985733
Craniomandibular Disorders, Inflammation
Istanbul, Beşiktaş, Turkey (Türkiye)
View Trial DetailsNCT06489431
Erectile Dysfunction, Genital Diseases
Mountain View, California, United States
View Trial DetailsNCT07664345
Aerobic Capacity, Exercise Recovery
Surabaya, Jawa Timur - East Java, Indonesia
View Trial DetailsNCT04691986
Atrophy, Frailty
Kansas City, Missouri, United States
View Trial Details