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

NCT07736521 | Not Yet Recruiting

• 1 other identifier: MBA-20-2026
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Facial Pain; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Keywords

Temporomandibular Joint Disorders; Arthrocentesis; Botulinum Toxin; TMJ Pain; Randomized Controlled Trial; Botox; Maximum Mouth Opening; Visual Analog Scale

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1 month, 3 months, and 6 months post-treatment

Study Arms (2)

Arthrocentesis

EXPERIMENTAL

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

Procedure: Arthrocentesis

Botulinum Toxin Injection

ACTIVE COMPARATOR

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

Drug: Botulinum Toxin-A

Interventions

Arthrocentesis PROCEDURE

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

Arthrocentesis

Botulinum Toxin-A DRUG

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.

Botulinum Toxin Injection

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mudher MB Alsunbuli: lead
• Al-Bayan University: collaborator

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Facial Pain

Interventions

Arthrocentesis; Therapeutic Irrigation; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Myofascial Pain Syndromes; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Hydrotherapy; Physical Therapy Modalities; Rehabilitation; Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor Dr.

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07