An interventional study of Arthrocentesis and Botulinum Toxin-A in Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome and Facial Pain, sponsored by Mudher MB Alsunbuli. Not yet recruiting. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Mudher MB Alsunbuli · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if arthrocentesis works as well as botulinum toxin (Botox) injection to treat pain and jaw dysfunction in adults with temporomandibular joint (TMJ) disorders.
The main questions it aims to answer are:
Researchers will compare arthrocentesis to Botox injection to see which treatment works better for reducing pain and improving jaw movement in patients with TMJ disorders.
Participants will:
609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.
This study's planned enrollment of 66 is above the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →This is the only study on the registry with Mudher MB Alsunbuli as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will undergo temporomandibular joint arthrocentesis, a minimally invasive joint lavage procedure.
Procedure: Arthrocentesis
Participants will receive an intramuscular injection of botulinum toxin (Botox) into the masticatory muscles (masseter and temporalis)
Drug: Botulinum Toxin-A
Temporomandibular joint (TMJ) arthrocentesis will be performed under local anesthesia using a standard two-needle technique. Two needles will be inserted into the superior joint space, and the joint will be irrigated with sterile isotonic solution (e.g., Ringer's lactate or normal saline, approximately 100-300 mL) to lavage inflammatory mediators and break minor intra-articular adhesions. The procedure will be performed as a single session by a trained oral and maxillofacial surgeon. Patients will be advised to follow a soft diet and may receive standard analgesics as needed following the procedure.
Also known as: lavage
Botulinum toxin type A (Botox) will be injected intramuscularly into the masseter and temporalis muscles bilaterally. Injection sites will be determined by palpation of muscle bulk and activity during voluntary contraction (patients will be asked to clench their teeth to identify the muscle borders and the point of maximal bulk/tenderness). The total dose will be 25-50 units per masseter muscle and 10-25 units per temporalis muscle, administered as a single session. The procedure will be performed by a trained physician experienced in botulinum toxin injection technique. Patients will be monitored for the onset of muscle relaxation effects, expected within days to weeks following injection.
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Pain intensity in the temporomandibular joint region will be measured using a Visual Analog Scale (VAS), a 0-10 point continuous scale where 0 indicates no pain and 10 indicates the worst pain imaginable. Participants will rate their pain at rest and during jaw movement/chewing at each study visit. The change in VAS score from baseline to 6 months will be compared between the arthrocentesis and botulinum toxin injection groups.
Time frame: Baseline, 1 month, 3 months, and 6 months post-treatment
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Temporomandibular Joint Disorders→