Not yet recruitingNAINTERVENTIONAL

L-PRF in Prevention of ORN and MRONJ Following Tooth Extractions;v3.0

If you've had radiotherapy for head and neck cancer or are taking certain medicines for bone health, tooth extractions can sometimes lead to serious jaw problems like ORN or MRONJ. These conditions can cause pain and make it hard to eat or speak. This study is testing a promising new treatment called L-PRF. This uses a small amount of your own blood to create a natural gel that's rich in healing factors. The gel is placed into the empty tooth socket after an extraction. Researchers want to see if L-PRF helps the jaw heal better and prevents these difficult jaw conditions from developing. Forty patients will take part, with some receiving L-PRF and others standard care, to compare the results.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Swansea Bay University Health Board

Enrolment target

Start

02 Aug 2026

Estimated completion

31 Jul 2028

Osteoradionecrosis of the Jaw Medicine Related Osteonecrosis of the Jaw

What is this study about?

If you've had radiation treatment for cancer in your head or neck, or are using certain medications to strengthen your bones, a simple tooth extraction can sometimes lead to serious problems with your jawbone. These problems, called Osteoradionecrosis (ORN) and Medication-Related Osteonecrosis of the Jaw (MRONJ), can cause a lot of pain, make it hard to eat or speak, and generally affect your quality of life. They happen because these treatments can make it harder for your jawbone to heal properly after an injury, like a tooth being pulled.

Currently, there aren't many good ways to prevent ORN or MRONJ, and once they develop, they can be very difficult to treat, often requiring complicated operations and long recovery times. This can put a big strain on patients and healthcare services. That's why researchers are looking for better ways to protect high-risk patients.

This study is investigating a new approach using something called L-PRF, which stands for Leukocyte- and Platelet-Rich Fibrin. This is a natural gel made from a small sample of your own blood, taken just before your extraction. This gel is packed with special growth factors and cells that are known to help wounds heal faster and reduce inflammation. The idea is that placing this L-PRF gel into your empty tooth socket after an extraction might help your jawbone heal better and prevent ORN or MRONJ from developing. This early study will help us understand if L-PRF could be a useful tool to keep your jaw healthy.

Key takeaways

This study evaluates L-PRF, a patient-derived blood product, for preventing serious jaw complications.
It targets patients at high risk of ORN or MRONJ after tooth extractions.
L-PRF is a gel made from your own blood, rich in healing factors.
The study compares L-PRF to standard care for wound healing and complication rates.
Participation involves tooth extraction, follow-up appointments for approximately one year, and no knowing if you received L-PRF or standard care.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and require at least one tooth extraction because the tooth is beyond saving. You also need to be able to visit the clinic for all your appointments over about a year and be happy to give your informed consent.

Specifically, you would either need to have had radiotherapy to your head or neck for cancer (with a certain radiation dose) or be currently taking (or have previously taken) certain medications to strengthen your bones, like bisphosphonates or denosumab. The study doctors will need to check your medical records for these details.

There are also reasons why you might not be able to join. For example, if you can't clean your teeth well, have uncontrolled health problems like diabetes, are taking certain medications that affect healing (like blood thinners or medicines that suppress your immune system), or if your tooth extraction is expected to be very complicated. You also can't be taking part in another clinical trial or have certain other jaw conditions.

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 need a tooth extraction because the tooth cannot be saved?
Have you had radiotherapy to your head or neck for cancer, OR are you taking (or have you taken) specific medications for bone health?
Are you able to attend follow-up appointments for about one year?
Do you have good general health and good oral hygiene?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have your tooth extracted, just as you would normally. Before the extraction, a small amount of your blood will be taken, similar to a routine blood test. This blood will be used to make the special L-PRF gel. You will then be randomly assigned to either receive the L-PRF gel placed into your empty tooth socket or to receive standard care, which means nothing extra will be put into the socket. You won't know which group you are in.

After your extraction, you'll have several follow-up appointments over about a year. Nurses or doctors will check how your mouth is healing at day 10, then again at 9, 17, 25, and 52 weeks after the extraction. These visits are to see how well the wound has healed and to check for any signs of the jawbone problems the study is trying to prevent. The total duration of your participation will be approximately one year.

Potential risks and benefits

Taking part in this study means you might benefit from L-PRF helping your jaw heal better and potentially reducing your risk of developing serious jaw problems like ORN or MRONJ. However, it's also possible that L-PRF may not work for you, or you might be in the group receiving standard care. The main risk involves the blood draw, which is typically very safe but can rarely cause a small bruise or discomfort. There are no known specific risks associated with L-PRF itself as it's made from your own blood. You are free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (1)

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

Morriston Hospital
Verified postcode
Swansea, United Kingdom

Common questions

What is L-PRF?

L-PRF is a natural gel made from a small sample of your own blood, which contains special cells and proteins that help your body heal and repair itself.

What are ORN and MRONJ?

These are serious, painful problems where the jawbone doesn't heal correctly after a tooth extraction, especially if you've had certain cancer treatments or bone-strengthening medicines.

Will I know if I'm getting L-PRF?

No, you won't know if you're getting the L-PRF treatment or standard care; this helps make sure the study results are fair and accurate.

How long will the study last for me?

If you take part, you'll have follow-up appointments over approximately one year to check on your healing.

Is the blood draw painful?

It's similar to a standard blood test and usually involves only a brief, mild discomfort when the needle is inserted.

How to find out more

Partha S Chakraborty

partha.chakraborty@wales.nhs.uk +44 7867063718 Official trial record

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