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Not yet recruitingNAINTERVENTIONAL

Mechanisms of Acute Inflammation Following Periodontal Treatment

This study aims to understand how treating gum disease affects inflammation in your body and the health of your blood vessels. Gum disease can lead to inflammation not just in your mouth but also throughout your body, which can impact conditions like heart disease. Standard gum treatment involves deep cleaning to remove plaque. This treatment can sometimes cause a short-term inflammatory response. We are investigating whether adding a special light treatment, called photodynamic therapy, after the standard gum cleaning can help kill harmful bacteria. The idea is that by reducing these bacteria more effectively, we might lessen the overall inflammation caused by gum disease and its treatment, potentially improving blood vessel health. This research could lead to better ways to treat gum disease and protect your overall health.

At a glance

Status
Not yet recruiting
Phase
NA
Sponsor
University College, London
Enrolment target
40
Start
01 Sep 2024
Estimated completion
31 Dec 2026

What is this study about?

Gum disease, also known as periodontitis, is a common issue where your gums become inflamed and infected. This happens because of an imbalance of germs in your mouth.

While gum disease affects your mouth, we know it can also cause inflammation throughout your entire body. This whole-body inflammation is why gum disease has been linked to other health problems, including heart disease. The usual treatment for gum disease involves thorough cleaning by a dentist or hygienist to remove plaque and hardened deposits from above and below your gum line. This cleaning helps get rid of the bacteria causing the problem. However, this treatment itself can sometimes trigger a short-term inflammatory response in your body, and briefly affect how well your blood vessels work.

Our blood vessels are lined with a protective layer called the endothelium. This lining helps keep your blood vessels healthy, reduce inflammation, and prevent blood clots. Over time, and due to factors like high blood pressure, cholesterol, sugar, or smoking, this lining can become less effective, a condition called endothelial dysfunction. There's growing evidence that gum disease and its treatment can affect this protective lining. In this study, we're looking at whether adding photodynamic therapy (PDT) to the standard gum cleaning can reduce the number of harmful bacteria more effectively. PDT uses a special light to help kill these bacteria. We hope that by doing this, we can reduce the body's inflammatory response after treatment and improve the health of your blood vessels.

Key takeaways

  • This study aims to understand how gum disease treatment affects inflammation and blood vessel health.
  • Gum disease can cause inflammation throughout the body and is linked to conditions like heart disease.
  • The study compares standard gum cleaning with standard cleaning plus a special light treatment (photodynamic therapy).
  • It investigates if the light therapy can reduce bacteria, lessen inflammation, and improve blood vessel function.
  • Results could lead to better ways to treat gum disease and protect overall health.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older, with a type of gum disease called periodontitis. You must have at least 20 teeth (excluding wisdom teeth) and a certain number of deep gum pockets.

There are some reasons why you might not be able to join. For example, if you have other serious health problems like diabetes, heart disease, kidney, liver, or lung conditions. Also, if you are pregnant or breastfeeding, you cannot participate. We also can't include you if you've recently used painkillers or antibiotics within the last month, or if you have serious untreated tooth decay or poor dental fillings.

Finally, you shouldn't be allergic to any of the materials used in the study, and you can't be taking part in another clinical study at the same time.

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 18 years old or older?
  2. Have you been diagnosed with periodontitis (gum disease)?
  3. Do you have at least 20 teeth (not counting wisdom teeth)?
  4. Do you have any serious health conditions like diabetes or heart disease?
  5. Are you currently pregnant or breastfeeding?
  6. Have you taken painkillers or antibiotics in the last month?
Answer every question to see your result.

What does participation involve?

The information provided does not fully describe what participation would involve in terms of visits, assessments, or overall duration. However, based on the description, it is likely that taking part would involve:

* **Dental Assessments:** This would include detailed checks of your gums and teeth. * **Treatment:** You would receive either standard gum cleaning (non-surgical periodontal therapy) or standard gum cleaning combined with photodynamic therapy. * **Blood Samples:** To measure inflammation and assess blood vessel health, it's highly probable that blood samples would be taken at different points before and after treatment. * **Blood Vessel Health Checks:** A specific test called "flow-mediated dilation (FMD) of the brachial artery" is mentioned, which measures how well your blood vessels expand. This would likely be done at least 24 hours after treatment. * **Follow-up:** There would likely be follow-up appointments to monitor your gum health and inflammation over a period, possibly up to a week after treatment, given the mention of a "one week acute inflammatory response."

The total duration of your participation would depend on the number of follow-up appointments, but at least one week post-treatment is indicated for observations.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving treatment for your gum disease, and potentially more effective treatment if the photodynamic therapy proves beneficial. You would also be contributing to important research that could lead to better treatments for gum disease and improved overall health for others. However, like with any medical procedure, there are potential risks. The standard gum cleaning can cause temporary discomfort, swelling, or bleeding. The photodynamic therapy might also have some side effects, though these are typically mild and temporary. Blood tests can cause a small bruise or discomfort. You are always free to withdraw from the study at any time without giving a reason, and it will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Eastman Dental Hospital
    Verified postcode
    London, United Kingdom

Common questions

What is periodontitis?

Periodontitis is another name for gum disease, which is when your gums get infected and inflamed due to bacteria in your mouth.

What is 'photodynamic therapy' (PDT)?

PDT is a special light treatment used to help kill bacteria, in this case, the bacteria causing gum disease.

Why is gum disease linked to heart disease?

Gum disease can cause inflammation throughout your body, and this inflammation is a factor that can contribute to other health issues, including heart problems.

What is 'endothelial dysfunction'?

This is when the inner lining of your blood vessels isn't working as well as it should, which can affect your heart health.

Will I get the new treatment?

Participants will be split into groups; one will receive the standard gum treatment, and the other will get the standard treatment plus the special light therapy (PDT). You won't know which group you are in.

How to find out more

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 "Mechanisms of Acute Inflammation Following Periodontal Treat…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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