AuthorisedTherapeutic exploratory (Phase II)Interventional

The usage of unenriched emulsified fat transplant in temporomandibular joint degenerative diseases

This study is investigating a new treatment for people with severe arthritis in their jaw joint, known as temporomandibular joint (TMJ) osteoarthritis. This condition, specifically Wilkes classifications 4-5, means the joint is significantly damaged. The treatment involves taking a small amount of fat from the patient’s own body, processing it to get special cells (called stromal vascular fraction), and then injecting these cells into the affected jaw joint. Researchers want to see if this treatment, which uses the body's own repair mechanisms, can help reduce pain and improve how well the jaw moves. This is an early-stage study to explore how effective and safe this new approach might be.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Tartu University Hospital

Enrolment target

Start

12 Mar 2025

Temporomandibular joint osteoarthritis Wilkes classification 4-5

What is this study about?

This study is about a new way to treat a type of arthritis that affects your jaw joint, called temporomandibular joint (TMJ) osteoarthritis. Think of your jaw joint like a hinge that connects your jawbone to the side of your head. When this hinge gets worn out or damaged, it can cause pain, clicking, and difficulty opening or closing your mouth. This study is specifically for people with more severe forms of this condition.

The treatment being tested uses something from your own body: your fat. Doctors will take a small amount of fat, usually from an area like your tummy or thigh. This fat is then carefully processed in a lab to gather special cells. These cells, called stromal vascular fraction, are thought to have properties that can help repair damaged tissues and reduce inflammation.

Once prepared, these special cells are injected back into your affected jaw joint. The main aim of this study is to see if this treatment can help reduce your pain and improve how well your jaw works. Researchers will be taking pictures (like X-rays or scans) and asking you questions through questionnaires to see how you are doing over time. This is an early phase of research, which means doctors are exploring if this treatment works and is safe before it can be offered more widely.

Key takeaways

This study is testing a new treatment for severe jaw joint arthritis.
It uses your body's own fat cells after they are specially processed.
The treatment involves a one-off injection into the jaw joint.
Researchers will check your progress with scans and questionnaires.
This is an early-stage study to see if the treatment works and is safe.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. There is no upper age limit, so people of many ages can potentially take part.

This study is open to both men and women. Your sex will not prevent you from being considered.

The main medical condition for this study is severe temporomandibular joint (TMJ) osteoarthritis. This means the arthritis in your jaw joint is quite advanced, specifically classed as Wilkes classification 4 or 5. Your doctor will be able to confirm if your condition matches this requirement.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have severe osteoarthritis in your jaw joint (TMJ)?
Have you been diagnosed by a doctor with Wilkes classification 4 or 5 TMJ osteoarthritis?
Are you able to attend several follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have screening appointments to make sure the study rules apply to you. If you qualify, you will receive the experimental treatment, which involves having some fat taken from your body, processed, and then injected into your jaw joint. This procedure will be explained to you in detail.

After the treatment, you will have several follow-up appointments. During these visits, doctors will collect information by doing scans or X-rays of your jaw and asking you to fill out questionnaires about your pain and jaw function. These appointments help the researchers understand how the treatment is working over time. The total duration of your participation, including all visits and follow-ups, will be clearly explained to you by the study team.

Potential risks and benefits

Potential benefits of taking part could include improvements in your jaw joint pain and movement if the treatment works. However, as this is an exploratory study, there's no guarantee the treatment will help you. Potential risks are associated with any medical procedure, such as discomfort, swelling, or infection where the fat is taken or injected. All specific risks will be fully explained to you. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Estonia

Common questions

What is TMJ osteoarthritis?

It's a type of arthritis that affects the joint connecting your jaw to your skull, causing pain, stiffness, and difficulty moving your jaw.

What does 'severe' mean in this study?

It means the jaw joint damage is quite advanced, specifically categorized as Wilkes classification 4 or 5 by medical professionals.

Where does the fat for the treatment come from?

It comes from your own body, usually taken from an area like your tummy or thigh during a minor procedure.

Will I know if I'm getting the actual treatment?

This study is exploring a new treatment, so everyone in it would receive the active intervention being tested, which is the processed fat cells.

How often will I need to visit the hospital?

The exact number and frequency of visits will be explained by the study team, but there will be initial appointments for screening and treatment, followed by several check-up visits.