RecruitingNAINTERVENTIONAL

Hyaluronic Acid and Polynucleotides for Supra-bony Defects

This pilot study wants to understand how wounds heal after a common gum surgery for a type of gum disease called 'periodontitis'. This disease can lead to 'supra-bony defects', where the bone supporting the tooth is lost, but the pocket of gum disease is still above the bone line. Researchers are comparing two treatments: the standard gum surgery alone, or the surgery combined with a special gel. This gel contains hyaluronic acid and polynucleotides. They will look closely at how the body starts to heal and how new blood vessels form in response to each treatment. The aim is to see if adding the gel helps the healing process. Up to 24 adults with periodontitis will take part at Queen Mary University of London.

At a glance

Status

Recruiting

Phase

Sponsor

Queen Mary University of London

Enrolment target

Start

21 Oct 2024

Estimated completion

01 Dec 2026

Periodontal Diseases Wound Heal Periodontal Inflammation Periodontal Pocket Periodontal Attachment Loss

What is this study about?

This study is looking into a common gum disease called periodontitis. If left untreated, periodontitis can cause the bone around your teeth to wear away, creating what dentists call 'supra-bony defects'. This means the gum infection forms a pocket that's still above the main bone level, but the bone itself is damaged. Usually, dentists perform a cleaning and a type of surgery called an 'access flap' to treat this. This surgery helps them clean the area thoroughly and reshape the gum.

The researchers in this study want to see if adding a special gel after this surgery can help the gums heal better. This gel is made of two main ingredients: hyaluronic acid and polynucleotides. Hyaluronic acid is a substance naturally found in the body that helps with healing and keeping tissues moist. Polynucleotides are small parts of DNA that can also help with tissue repair. They want to understand the very first steps of healing and how new blood vessels grow, as this is crucial for healthy tissue repair.

This is a 'pilot study', which means it's a smaller, early-stage study designed to get initial information. It will compare the standard surgery alone against the surgery combined with the special gel. By doing this, they hope to learn more about how this gel might improve healing for people with periodontitis and supra-bony defects, potentially leading to better treatments in the future.

Key takeaways

This study compares standard gum surgery with surgery plus a special gel for gum disease.
It aims to understand early wound healing and blood vessel formation in the gums.
People with specific types of gum disease and bone loss (supra-bony defects) are eligible.
Participation involves 7 clinic visits over at least 4 months.
You won't know which treatment you receive during the study.

Who may be eligible?

To be considered for this study, you need to be an adult (18 years or older) and generally healthy, but with active 'periodontitis' – a serious form of gum disease. Specifically, you should have a certain level of gum disease (Stage III or IV) and have specific bone damage around your teeth, called 'supra-bony defects'. This would be confirmed by your dentist with examinations and X-rays. You also need to have recently had a thorough professional clean of your teeth and gums (within the last four months).

There are several reasons why you might not be able to join. For example, if you are a heavy smoker (10 or more cigarettes a day), or if you have certain other health conditions like uncontrolled diabetes or serious liver or kidney problems. You also generally can't join if you're taking medications that affect bone health or blood clotting, or if you've had previous gum surgery in the area they want to study. Issues like untreated tooth decay, severe mobile teeth, or certain complex root infections would also exclude you. Pregnant individuals also cannot participate.

The research team will need to check your full health history to make sure taking part is safe for you and that you meet all the specific requirements for the study. If you're interested, it's best to discuss all your health conditions and medications with the study team.

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 have stage III or IV periodontitis?
Have you recently had a thorough dental cleaning for your gums (within 4 months)?
Are you a non-smoker, or do you smoke less than 10 cigarettes a day?
Do you generally have good health, without uncontrolled diabetes or other serious conditions?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a total of seven visits to the clinic over at least four months. During these visits, the study team will carry out the necessary gum surgery and assess your healing progress. You'll receive either the standard gum surgery or the surgery combined with the special gel; this will be decided randomly, like flipping a coin. They will carefully monitor your gums, take measurements, and likely collect small tissue samples to understand the early healing process and how new blood vessels form. You won't know which treatment you receive until after the study is complete. The total duration of your active involvement in the study will be at least four months.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that you might receive a treatment that could lead to improved gum healing, and you would be contributing to new medical knowledge that could help others in the future. However, there's no guarantee the treatment will work better than the standard care. Potential risks are similar to any gum surgery, including discomfort, swelling, or a small risk of infection. You will be closely monitored for any problems. Remember, taking part in this study is completely voluntary, and you are free to withdraw at any time without giving a reason, and this will not affect your future medical care.

Locations (2)

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

Barts Health NHS Trust Dental Hospital
Verified postcode
London, United Kingdom· Recruiting
Centre for Oral Clinical Research (COCR)
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'periodontitis'?

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

What are 'supra-bony defects'?

These are areas where the bone around your tooth has been damaged by gum disease, but the gum pocket isn't extending deep into the bone itself. It usually means the bone loss is more horizontal.

What is hyaluronic acid and polynucleotides?

Hyaluronic acid is a substance naturally in your body that helps with healing. Polynucleotides are small pieces of genetic material that can also help repair tissues. They are being tested in a gel form here.

Will I know which treatment I'm getting?

No, you won't know if you're getting the standard surgery or the surgery with the special gel until the study is finished. This helps ensure the results are unbiased.

How long will I be involved in the study?

You will need to attend appointments over a period of at least four months.

How to find out more

Miljana Bacevic

bhnt.clinicaloralresearchcentre@nhs.net +442078823063 Official trial record

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