Arthrocentesis Versus Botulinum Toxin Injection in Patients With Temporomandibular Joint Disorders: A Randomized Controlled Trial (RCT)

Mudher MB Alsunbuli

Status: Not yet enrolling

Conditions: Temporomandibular Joint Disorders; Facial Pain; Temporomandibular Joint Dysfunction Syndrome

Treatments: Drug: Botulinum Toxin-A; Procedure: Arthrocentesis

Study type: Interventional

Funder types: Other

Identifiers

NCT07736521

MBA-20-2026

Details and patient eligibility

About

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

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically and radiographically confirmed temporomandibular joint (TMJ) disorder, diagnosed according to Wilkes staging or the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)
• Age 18 years or older
• Symptom duration of at least 3 months
• Unresponsive to conservative therapy
• Willing and able to provide written informed consent

Exclusion criteria

• Previous TMJ surgery
• Systemic rheumatic/inflammatory joint disease (e.g., rheumatoid arthritis, ankylosing spondylitis)
• Bony ankylosis of the TMJ
• Pregnancy
• Known allergy or contraindication to botulinum toxin
• Concurrent use of muscle relaxants, corticosteroids, or anticoagulant medication that may confound treatment effects
• Unwillingness or inability to attend scheduled follow-up visits

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Arthrocentesis

Experimental group

Description:

Participants will undergo temporomandibular joint arthrocentesis, a minimally invasive joint lavage procedure.

Treatment:

Procedure: Arthrocentesis

Botulinum Toxin Injection

Active Comparator group

Description:

Participants will receive an intramuscular injection of botulinum toxin (Botox) into the masticatory muscles (masseter and temporalis)

Treatment:

Drug: Botulinum Toxin-A