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RecruitingNAINTERVENTIONAL

Autologous Platelet Concentrate (APC) in Intrabony Defects

This 12-month study at Barts and The London Dental Hospital looks at two ways to treat severe gum disease (periodontitis). Both treatments involve a small gum operation to reduce deep gum pockets and encourage bone and gum to regrow. One method uses a product made from the patient's own blood platelets, which helps healing. The other uses a widely-used animal-derived bone graft and membrane. We want to see which treatment works better for regenerating damaged tissue and how it affects patients' daily lives. We will recruit 74 healthy patients, aged 25 or older, and they will be randomly assigned to receive one of the two treatments.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Queen Mary University of London
Enrolment target
74
Start
02 Mar 2021
Estimated completion
31 Dec 2026

What is this study about?

This study is designed to help people who have severe gum disease, also known as periodontitis. This condition can damage the soft tissues and bone that support your teeth. Our aim is to investigate two different surgical treatments that help to repair this damage and reduce the deep pockets that form around the teeth.

One treatment uses a special product made from your own blood, called platelet concentrate. This is thought to help boost your body's natural healing process. The other treatment involves using a material derived from animals, which has been used successfully in dentistry for many years, to help new bone grow. Both of these treatments are designed to help your gums and bone recover from the effects of gum disease.

We will be comparing these two treatments over 12 months to see which one works best at repairing the damage and improving gum health. We also want to understand patients' experiences with each treatment, including how they feel afterwards and what impact it has on their daily lives. By doing this, we hope to find better ways to treat gum disease in the future.

Key takeaways

  • This study compares two surgical treatments for severe gum disease.
  • One treatment uses your own blood, the other an animal-derived bone graft.
  • It aims to see which treatment best helps mend damaged bone and gum.
  • You'll have a small gum operation and several follow-up appointments.
  • Your feedback on the treatment's impact on your daily life is important.
  • This research could help improve future gum disease treatments.

Who may be eligible?

To be part of this study, you need to be at least 25 years old and generally healthy, without certain medical conditions. You should have clear signs of gum disease with a specific type of bone damage around your teeth that can be treated. It's also important that your general gum health, like bleeding and plaque levels, is reasonably good after recent cleaning, and you haven't had gum surgery in the study area in the last year.

There are also some reasons why you wouldn't be able to join. For example, if you have certain health problems like diabetes, kidney, or liver disease, or if you're taking specific medications like strong blood thinners or steroids for a long time, you wouldn't be eligible. Heavy smoking (10 or more cigarettes a day), a history of alcohol or drug misuse, or being pregnant or breastfeeding would also mean you couldn't take part. We also can't include you if you've recently had certain antibiotics or anti-inflammatory drugs.

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.

  1. Are you 25 years old or older?
  2. Do you have severe gum disease with specific bone damage?
  3. Are you generally healthy, without certain long-term conditions like diabetes or serious heart problems?
  4. Do you smoke less than 10 cigarettes a day?
  5. Are you not pregnant or breastfeeding?
  6. Have you not had gum surgery in the specific tooth area in the last year?
Answer every question to see your result.

What does participation involve?

If you agree to take part, the study will involve nine visits to the Barts and The London Dental Hospital over at least 13 months. Your first visit will involve explaining the study in detail, checking your health history, and taking some measurements. You'll also have an X-ray and some scans. We'll clean your teeth and give you oral hygiene advice at this visit. You'll then be randomly (by chance) assigned to one of the two treatment groups.

Within six weeks of your first visit, you'll have a small gum operation. After the surgery, there will be follow-up appointments where we'll check your gum health, take more measurements, and ask you to complete questionnaires about your experience. You'll have another X-ray at 12 months to see how your bone has healed. We'll also be using non-invasive methods, like special scans, to check things like temperature and blood flow around your gums and face at different times.

Potential risks and benefits

Potential benefits of taking part include receiving advanced treatment for your gum disease, which could help your gums and bone heal and improve your overall oral health. You'll also be contributing valuable information that could help others with similar conditions in the future. As with any surgery, there are potential risks, such as discomfort, swelling, or a small chance of infection. We will closely monitor you throughout the study for any issues. You are free 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.
  • Barts and The London Dental Hospital
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is periodontitis?

Periodontitis is a severe gum infection that damages the soft tissue and bone supporting your teeth. It can lead to tooth loss if not treated.

What is a 'gum pocket'?

A gum pocket is a space that forms between your tooth and gum when gum disease pulls the gum away from the tooth. Bacteria gather here, making the disease worse.

Will I know which treatment I'm getting?

No, you will not know which treatment you receive. This helps us ensure the results are fair and unbiased.

How long will I be in the study?

The study involves a minimum of 9 visits over at least 13 months, with the main treatment happening early on and follow-up appointments afterwards.

Is the treatment painful?

You will receive anaesthetic during the surgery to minimise any pain. You may experience some discomfort or swelling afterwards, which can usually be managed with painkillers.

How to find out more

Elena Calciolari, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Autologous Platelet Concentrate (APC) in Intrabony Defects…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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