A multicentre clinical trial: Alveolar bone augmentation using MSCs and biphasic calcium phosphate granules prior to dental implants (Behandling Maxillofacial)
This study is investigating a new way to help people grow more jaw bone when their jaw is too thin for dental implants. It uses special cells, called mesenchymal stem cells (MSCs), combined with a bone-filling material. If successful, this could allow more people to have dental implants, which are a long-lasting way to replace missing teeth. We're mainly looking at how much the jaw bone grows bigger over six months, using special 3D X-rays before the dental implants are placed. We're also checking how easy it is to place the implants, if there are any side effects, and how patients feel about the treatment. The study is currently in larger phases (Phase II and III), meaning it's being tested more widely after earlier safety checks.
At a glance
What is this study about?
This research study is about helping people who need dental implants but don't have enough jaw bone to support them. Sometimes, after teeth are removed or due to other health reasons, the jaw bone can become too thin. To put in a sturdy dental implant, you often need a certain amount of bone. This study is testing a method called 'bone augmentation' which means adding material to help grow new bone.
In this study, doctors are using a special approach that involves mesenchymal stem cells (MSCs) along with a bone-filling material. MSCs are special cells that can help repair and regenerate tissues, including bone. The hope is that by using these cells, the new bone will grow effectively, making the jaw strong enough for dental implants.
The main thing researchers want to find out is how much thicker the jaw bone becomes after six months, using special 3D X-ray scans. They also want to see if dental implants can then be successfully placed in the newly grown bone. Importantly, they are also very focused on safety, monitoring for any side effects, and understanding how patients feel about the treatment and their quality of life. This research could lead to better ways to prepare people for dental implants in the future.
Key takeaways
- Exploring a new way to grow jaw bone for dental implants.
- Uses special cells (mesenchymal stem cells) and bone-filling material.
- Aims to thicken jaw bone for better implant support.
- Mainly checking bone growth over 6 months with 3D X-rays.
- Also looking at safety, side effects, and patient satisfaction.
- For adults with jawbones too thin for standard implants.
Who may be eligible?
This study is for adults, aged 18 and over, regardless of their gender. You might be suitable if you have parts of your jawbone that are too thin, specifically less than 4 millimetres in width, and you need more bone to have dental implants.
To be considered, you'll have specific bone defects in your jaw. The medical team will check your jaw carefully using scans to see if your bone shape and measurements match what's needed for the study.
There might be other health conditions that would prevent you from joining, but the medical team will discuss all the details with you to see if this study is a good fit for your situation.
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 dental implants but have been told your jaw bone is too thin?
- Have you been diagnosed with bone defects in your jaw that are less than 4mm wide?
- Are you able to attend appointments over a 6-month period for assessments and scans?
What does participation involve?
If you join this study, you would undergo a procedure to have special mesenchymal stem cells and bone-filling material placed in your jaw. After this, you would have several follow-up appointments and assessments over a period of 6 months. This would include special 3D X-ray scans (CBCT images) at the beginning and at 6 months to measure bone growth, and physical checks of your mouth around 2 and 4 weeks, and at 6 months to check how you're healing.
During your visits, you might be asked about any pain you're experiencing and about your general satisfaction with the treatment using questionnaires. There will also be some blood samples taken at the start and after 2 weeks to understand the cells better. At the 6-month mark, just before dental implant placement, small bone samples might be taken. The total duration of the main study assessments before implant placement is 6 months, but there will be ongoing checks about the dental implants after they are fitted.
Potential risks and benefits
Locations (2)
- —UnverifiedSpain
- —UnverifiedNorway
Common questions
What are mesenchymal stem cells?
These are special cells found in the body that can help repair and grow new tissues, including bone. In this study, they are used to encourage new jaw bone growth.
How long will the study last for me?
The main part of the study, assessing bone growth, will last for 6 months after the initial procedure. However, there will be checks on your dental implants after this time too.
Will I have dental implants in this study?
This study aims to grow enough bone so that dental implants can be placed 6 months after the bone-building procedure. The success of implant placement is a key part of what they are measuring.
What kind of scans will I have?
You will have special 3D X-ray scans called CBCT images at the beginning and after 6 months. These help measure the changes in your jaw bone.
Will I experience pain?
As with any surgical procedure, you might experience some pain or discomfort. The study will monitor your pain levels and ask about them. Your doctors will discuss pain relief options with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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