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Arthrocentesis Versus Botulinum Toxin Injection in Patients With Temporomandibular Joint Disorders: A Randomized Controlled Trial
Sponsor: Mudher MB Alsunbuli
Summary
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: * Does arthrocentesis reduce pain more, less, or the same as Botox injection? * Does arthrocentesis improve jaw opening and function more, less, or the same as Botox injection? * What side effects do participants have with each treatment? 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: * Be randomly assigned to receive either arthrocentesis (a joint-washing procedure) or a Botox injection into the jaw muscles * Visit the clinic at 1, 3, and 6 months after treatment for checkups and assessments - Rate their pain and have their jaw movement measured at each visit * Complete short questionnaires about their jaw function and quality of life
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2026-08-15
Completion Date
2027-05-01
Last Updated
2026-07-30
Healthy Volunteers
No
Interventions
Arthrocentesis
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.
Botulinum Toxin-A
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.