Not yet recruitingNAINTERVENTIONAL

Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw

This research is investigating a jawbone condition called Medication-related Osteonecrosis of the Jaw (MRONJ). This can be a side effect of certain medicines used for bone conditions like osteoporosis. While surgery can help, doctors are always looking for ways to improve healing. This study will compare standard jaw surgery for MRONJ with surgery that includes a special material called L-PRF (Leukocyte- and Platelet-Rich Fibrin). L-PRF is made from the patient’s own blood and is thought to help wounds heal by releasing important healing factors. The aim is to see if L-PRF helps the surgical area heal more completely and prevents further problems.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital, Toulouse

Enrolment target

150

Start

01 May 2024

Estimated completion

01 May 2027

Osteonecrosis of the Jaw

What is this study about?

This study is about a condition called Medication-related Osteonecrosis of the Jaw, often shortened to MRONJ. It's a rare but serious problem that can affect the jawbone. It can happen as a side effect for some people taking specific medications for bone conditions, such as osteoporosis or cancer that has spread to the bones. MRONJ can cause pain, infection, and can make daily life difficult.

Currently, surgery can be a good way to treat MRONJ and help people feel better. However, doctors are always looking for ways to make these surgeries even more successful and ensure the wound heals properly. This study is testing a new approach during surgery that uses a special material called L-PRF (Leukocyte- and Platelet-Rich Fibrin). L-PRF is made from a small sample of the patient's own blood, which is spun to separate out a healing gel. This gel contains important cells and proteins that can help wounds repair themselves.

The main aim of this study is to see if adding this L-PRF gel to the surgical area helps the wound heal more completely after surgery for MRONJ. Doctors believe that L-PRF might release natural healing substances slowly over time, which could encourage better blood flow and faster recovery. By comparing patients who have standard surgery with those who also receive L-PRF, the researchers hope to find a better way to treat MRONJ and improve patients' healing and quality of life.

Key takeaways

This study compares standard jaw surgery for MRONJ with surgery that includes a natural healing gel (L-PRF) from your own blood.
The goal is to see if L-PRF helps surgical wounds heal better after treatment for MRONJ.
Participants will be carefully monitored for 6 months to track healing, pain, and quality of life.
L-PRF is made from your own body, making it a natural way to support healing.
The research aims to improve future treatment for people with MRONJ.

Who may be eligible?

To join this study, you would need to have been diagnosed with Medication-related Osteonecrosis of the Jaw (MRONJ) that requires surgery. This usually means your MRONJ is at a certain stage (stage 2 or 3) and other initial treatments haven't worked or part of the bone needs to be removed. The surgery for the study would need to be carried out under general anaesthesia (being put to sleep).

There are also some important reasons why you might not be able to join. For example, if you have a cancerous growth in your jaw area, or if you have several MRONJ spots in your jaw. You also couldn't take part if you've had radiation treatment to your head and neck area in the past, or if you're unable to have general anaesthesia. Finally, if doctors estimate your life expectancy to be less than 6 months, you wouldn't be able to participate.

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.

Do I have MRONJ that needs surgery?
Do I need general anaesthesia for my MRONJ surgery?
Do I have cancer in my jaw or multiple MRONJ lesions?
Have I had radiotherapy to my head or neck in the past?
Am I able to have general anaesthesia safely?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first need to sign a consent form, showing you understand what is involved. You will have surgery for your MRONJ. Some patients will receive the standard surgery, while others will have the new L-PRF treatment added during their surgery. You won't know which group you are in, and neither will your doctors, to ensure the results are fair.

After your surgery, doctors will regularly monitor how well your wound is healing. You will have follow-up visits over 6 months to check on your recovery, how much pain you might be experiencing, and how the quality of your life and mouth health has been affected. You will also be asked about any unexpected problems or side effects.

Potential risks and benefits

Taking part in this study may offer the potential benefit of improved wound healing after your MRONJ surgery, especially if you receive the L-PRF treatment. However, as with any surgery, there are always risks, including infection, pain, and issues with healing. The L-PRF is made from your own blood, which helps reduce certain risks, but the effectiveness of this new approach isn't yet fully proven. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

University Hospital - Centre François-Xavier Michelet
Verified postcode
Bordeaux, France
University Hospital - Groupe hospitalier Pellegrin
Verified postcode
Bordeaux, France
University Hospital
Verified postcode
Limoges, France
University Hospital Gui de CHAULIAC
Verified postcode
Montpellier, France
University Hospital Pitié-Salpêtrière
Verified postcode
Paris, France
University Hospital
Verified postcode
Toulouse, France
University Hospital
Verified postcode
Toulouse, France

Common questions

What is MRONJ?

MRONJ stands for Medication-related Osteonecrosis of the Jaw. It's a condition where parts of the jawbone can become damaged and exposed, often linked to certain medicines for bone health.

What is L-PRF?

L-PRF is a special gel made from your own blood. It's rich in cells and proteins that can help wounds heal and is used during surgery.

Will I know if I get the L-PRF treatment?

No, you won't know if you receive the L-PRF or standard surgery. This is to make sure the study results are fair and unbiased.

How long will I be followed in the study?

You will be followed by the study team for 6 months after your surgery to check on your healing and well-being.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting the medical care you receive.

How to find out more

Franck DELANOË, MD

delanoe.f@chu-toulouse.fr +33 5 61 77 74 76 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.