RecruitingPHASE2INTERVENTIONAL

Human Amniotic Membrane (hAM) for Stage II Maxillomandibular Osteonecrosis Management

This study is investigating a new treatment for a jawbone condition called Stage II Medication-Related Osteonecrosis of the Jaw (MRONJ). MRONJ can happen to people who take certain medications for cancer or bone thinning. It causes the jawbone to become damaged and not heal properly. The research aims to see if adding a special patch, made from a human amniotic membrane, to standard jaw surgery helps the bone heal faster and better. Previous small studies have shown promising results, suggesting it might reduce pain, prevent infection, and improve recovery. The study will compare how well people recover with and without this new patch three months after surgery. This is a Phase 2 study, meaning it’s an early step to see if the treatment is safe and effective.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre Hospitalier Universitaire de Besancon

Enrolment target

Start

22 Sep 2023

Estimated completion

01 Mar 2026

Osteonecrosis Due to Drugs, Jaw

What is this study about?

This study is focused on a health problem called Medication-Related Osteonecrosis of the Jaw (MRONJ). This condition can affect the jawbone in people who have taken certain powerful medications. These medicines are often used to treat cancer or to make bones stronger in conditions like osteoporosis (thinning bones). Sometimes, these medications can, as a side effect, make it harder for the jawbone to heal and renew itself naturally, leading to damage.

When MRONJ happens, it can be quite serious. In Stage II MRONJ, part of the jawbone might become exposed and can cause pain or infection. Currently, there isn't one agreed-upon way to treat this condition, but doctors often use antibiotics, clean the area, and sometimes remove the damaged bone. The main goal of treatment is usually to get the soft tissue in the mouth to heal over the exposed bone to protect it. If Stage II MRONJ isn't treated effectively, it can become worse, leading to more severe problems.

This is where the new treatment comes in. Researchers are looking at something called a human amniotic membrane (hAM). This is a very thin, special tissue that comes from the fluid sac around a baby during pregnancy. It's thought to have properties that could help healing. For example, it's known to reduce swelling, fight off germs, and encourage tissue to regrow. Earlier small studies have shown that using this membrane in people with MRONJ might help their mouths heal, reduce pain, and prevent infections. This new study wants to confirm if adding this special membrane during standard jaw surgery truly helps people with Stage II MRONJ heal better and more quickly at three months after the operation, and also look at things like pain and infection.

Key takeaways

This study evaluates a new treatment for jawbone damage (MRONJ) caused by certain medications.
It combines standard jaw surgery with a special healing membrane from human tissue.
The goal is to improve jawbone healing, reduce pain, and prevent infections.
Previous small studies have shown promising results with this membrane.
This is a Phase 2 study, an early step to confirm safety and effectiveness.
Participation involves either standard surgery plus the membrane, or standard surgery only.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older, both men and women are welcome. You must have been treated for a cancer-related illness where you received medications like bisphosphonates, Denosumab, or anti-angiogenics, which are medicines that can sometimes lead to jaw problems. Importantly, you need to have a specific type of jaw problem called Stage II MRONJ, which your doctor will confirm both with an examination and with X-rays or scans. You also need to be able to understand the study and agree to participate by signing a consent form.

There are also some reasons why you wouldn't be able to join. For example, if your doctors believe you have less than six months to live, or if you have certain types of growing cancers in your head or neck area, you wouldn't be eligible. If you've had radiation therapy to your head or neck in the past, or if you're allergic to specific antibiotics used in the study, you also wouldn't qualify. People with very early (Stage I) or very advanced (Stage III) MRONJ are not included in this particular study, nor are those whose MRONJ is only due to osteoporosis, rather than the specified cancer-related medications.

Finally, if you have other health conditions that might affect your bones or mouth tissues, like severe bone diseases, or if you're taking long-term steroid medications or drugs that suppress your immune system, you might not be able to participate. The study also cannot include anyone who is not fit enough for surgery, either under local or general anaesthetic.

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?
Have you taken medications for cancer or bone thinning that might cause jaw problems?
Has a doctor confirmed you have Stage II MRONJ, both by examination and scans?
Are you fit enough to have jaw surgery under local or general anaesthetic?
Do you not have any active cancer in your head or neck area?
Have you NOT had radiation therapy to your head or neck in the past?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either the standard jaw surgery for Stage II MRONJ plus the new treatment (a human amniotic membrane patch), or just the standard surgery. The researchers will decide which treatment you receive by chance, like flipping a coin. You will have regular appointments and checks before the surgery, during your recovery, and for three months afterwards. These checks will involve your doctors examining your mouth, checking for pain, and looking for any signs of infection. They will also assess how well your mouth lining and jawbone are healing. You might need to have some X-rays or scans. The general duration of your active participation, including follow-up, will be around three months after your surgery.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a treatment that could help your jawbone heal better and faster, reduce pain, and prevent infection. However, like any medical procedure, there are potential risks associated with both the surgery and the new membrane, such as typical surgery risks or unexpected reactions to the membrane. You will be closely monitored for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

CHU de Besancon
Verified postcode
Besançon, France· Recruiting
CHU Bordeaux Pellegrin
Verified postcode
Bordeaux, France· Not yet recruiting
CHU de Dijon
Verified postcode
Dijon, France· Not yet recruiting
CHR Metz Thionville
Verified postcode
Metz, France· Not yet recruiting
CHU de Reims
Verified postcode
Reims, France· Not yet recruiting

Common questions

What is MRONJ?

MRONJ stands for Medication-Related Osteonecrosis of the Jaw. It's a condition where the jawbone can become damaged and doesn't heal well, often as a side effect of certain strong medications used for cancer or bone-thinning.

What is a human amniotic membrane (hAM)?

A human amniotic membrane is a special, thin tissue from the sac that surrounds a baby during pregnancy. It's thought to help reduce swelling, fight germs, and encourage healing.

What is 'standard surgical management'?

This refers to the usual operations doctors perform to treat Stage II MRONJ, which can include cleaning the area, removing damaged bone, and trying to heal the surrounding soft tissues.

Why are you doing this study?

We want to see if adding the human amniotic membrane during standard jaw surgery can help people with Stage II MRONJ heal better, reduce pain, and prevent infections compared to standard surgery alone.

What does 'Phase 2' mean for a clinical trial?

Phase 2 means this is an early stage of research where we are looking more closely at whether a new treatment is safe and effective for a specific condition, after initial safety checks. It's not yet a widely available treatment.

How to find out more

Florelle GINDRAUX, PhD

fgindraux@chu-besancon.fr 033381218998 Official trial record

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