Temporomandibular Joint DisordersRCTNCT07736521
Arthrocentesis Versus Botulinum Toxin Injection in Patients With Temporomandibular Joint Disorders: A Randomized Controlled Trial
A study testing Arthrocentesis and Botulinum Toxin-A in people with Temporomandibular Joint Disorders and Temporomandibular Joint Dysfunction Syndrome, run by Mudher MB Alsunbuli.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Facial Pain
- What is being tested?
- Arthrocentesis and Botulinum Toxin-A
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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:
Read more
- 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
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Facial Pain
- Being tested
- Arthrocentesis, Botulinum Toxin-A
- Keywords
- Temporomandibular Joint Disorders, Arthrocentesis, Botulinum Toxin, TMJ Pain, Randomized Controlled Trial, Botox, Maximum Mouth Opening, Visual Analog Scale
- Medical subject headings
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthrocentesisProcedure or surgery
Also called lavage
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-ADrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arthrocentesis | Experimental | Participants will undergo temporomandibular joint arthrocentesis, a minimally invasive joint lavage procedure. Receives: Procedure: Arthrocentesis |
| Botulinum Toxin Injection | Active comparator | Participants will receive an intramuscular injection of botulinum toxin (Botox) into the masticatory muscles (masseter and temporalis) Receives: Drug: Botulinum Toxin-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 3 months, and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mudher MB Alsunbuli
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Bayan University
- Responsible party
- Sponsor-investigator, Mudher MB Alsunbuli, Al-Bayan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736521
- Sponsor's protocol ID
- MBA-20-2026
- Acronym
- RCT
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthrocentesis Versus Botulinum Toxin Injection in Patients With Temporomandibular Joint Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07736521
- Acronym / sponsor ID
- RCT / MBA-20-2026
- Conditions
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Facial Pain
- Keywords
- Temporomandibular Joint Disorders, Arthrocentesis, Botulinum Toxin, TMJ Pain, Randomized Controlled Trial, Botox, Maximum Mouth Opening, Visual Analog Scale
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Mudher MB AlsunbuliUniversity, hospital or other
- Collaborators
- Al-Bayan University
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthrocentesis | Experimental | Procedure: ArthrocentesisParticipants will undergo temporomandibular joint arthrocentesis, a minimally invasive joint lavage procedure. |
| Botulinum Toxin Injection | Active comparator | Drug: Botulinum Toxin-AParticipants will receive an intramuscular injection of botulinum toxin (Botox) into the masticatory muscles (masseter and temporalis) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArthrocentesisAlso: lavageTemporomandibular 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. | Procedure or surgery | Arthrocentesis |
| Botulinum Toxin-ABotulinum 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. | Drug | Botulinum Toxin Injection |
Primary outcome
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Time frame: Baseline, 1 month, 3 months, and 6 months post-treatment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrocentesis and Botulinum Toxin-A in people with Temporomandibular Joint Disorders and Temporomandibular Joint Dysfunction Syndrome, run by Mudher MB Alsunbuli.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity Measured by Visual Analog Scale (VAS) (time frame: Baseline, 1 month, 3 months, and 6 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.