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Can a Blood-Based injection and botox ease jaw joint pain?

NCT ID NCT06207955

Disease control Sponsor: Fayoum University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial tests whether injecting platelet-rich fibrin (a substance made from the patient's own blood) into the jaw joint, along with botulinum toxin (Botox) into a nearby muscle, improves symptoms of anterior disc displacement, a common TMJ disorder. The study includes 39 people aged 16 to 45 with painful jaw movement, clicking sounds, and limited mouth opening. Participants receive one of three treatments: the combined injections, platelet-rich fibrin alone, or a saline washout. Researchers measure mouth opening, joint sounds, and jaw movement over six months to see which approach works best.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Platelet-rich fibrin (I-PRF) injected into the jaw joint, plus botulinum toxin type A injected into a jaw muscle, after a joint washout procedure (arthrocentesis)
What this could lead to
If it works, this combination could offer a more effective, minimally invasive treatment for painful TMJ disc displacement, improving jaw opening and reducing joint sounds.
What could go wrong
This is a small, early-stage trial with 39 participants, so results may not apply broadly. Injections carry risks like pain, swelling, or muscle weakness, and the added benefit over standard care is unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

39 people

The number who actually took part.

Started

Jan 2024

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 45 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with painful tmj during jaw movements * Patients with joint sounds ( clicking ) during jaw opening and mastication * Patients age range from 16 years old to 45 years old * Patients with Class I maxillo-mandibular relationship * Patients with reduced mouth opening * All patients diagnosed clinically and radiographically by MRI as TMJ anterior disc displacement with reduction Exclusion Criteria: * Patient with history of recent trauma * Patients with malocclusion * Patients with systematic condition that affect bone and joints such as osteoarthritis , systemic lupus and epilepsy . * Patients allergic to botox injection * Pregnant or lactating females * Patients with non-reducible disc on MRI * Patients contraindicated to exposure to MRI * Patients with previous tmj arthrocentesis , arthroscopy or TMJ surgery * Significant mechanical obstruction that prevents mouth opening, acute capsulitis, benign or malignant temporomandibular joint lesions. * Patients with blood diseases, and coagulation disorders

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Conditions

The condition(s) this trial relates to.

temporomandibular joint disorder temporomandibular joint dysfunction syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

TMJ disc disorder TMJ pain

Contacts and locations

Locations

  • Faculty of Dentistry Fayoum University

    Al Fayyum, Egypt

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