Not yet recruitingNAINTERVENTIONAL

Endo-perio Disease - Treatment Outcomes Using Conventional and Hydraulic Calcium Silicate Sealer With or Without LPRF

This study aims to find better ways to treat a complex dental condition where both the tooth's inner pulp (nerves and blood vessels) and the surrounding gums and bone are damaged. This problem, called endo-perio disease, can cause severe issues if not treated effectively. The research compares standard root canal filling materials with newer, more advanced ones that may offer better healing. It also investigates if adding a natural healing booster, made from your own blood (called L-PRF), can improve gum and bone regeneration around affected teeth. By testing these different approaches, the study hopes to discover treatments that lead to faster healing and better long-term results for patients.

At a glance

Status

Not yet recruiting

Phase

Sponsor

King's College London

Enrolment target

115

Start

01 May 2023

Estimated completion

01 May 2033

Endodontic Disease Periodontitis

What is this study about?

This study is about a complex dental problem where a tooth's inner part (the pulp, which contains nerves and blood vessels) and the surrounding gums and bone (periodontium) are both unhealthy. You can think of the pulp as the living core of your tooth and the periodontium as the foundation that holds it in place. When both are affected, it's called endo-perio disease. This can happen because tiny connections exist between the inside of your tooth and the area around its roots, allowing problems to spread between them.

Treating endo-perio disease can be tricky, as it often requires both a root canal (to fix the inside of the tooth) and gum treatment (to heal the surrounding tissues). This study is exploring if using newer materials for root canal fillings and adding a natural healing boost can lead to better outcomes. The newer materials for root canal fillings are called "hydraulic calcium silicate sealers" – they are designed to be very good at sealing the tooth and encouraging healing.

The other part of the study looks at using something called L-PRF (Leukocyte Platelet-Rich Fibrin). This is a special gel made from a small sample of your own blood, which is then placed in the area needing repair. It's rich in healing factors that can help your body regenerate bone and gum tissue. The goal is to see if combining these new approaches leads to quicker healing and a more successful repair of the tooth and its surrounding structures, compared to traditional methods.

Key takeaways

New study on complex tooth and gum disease.
Compares standard treatments with new materials and a natural healing boost (L-PRF).
L-PRF is made from your own blood to promote tissue repair.
Aims for faster healing and better long-term results.
Participation involves dental treatments and follow-up checks.

Who may be eligible?

To join this study, you generally need to be between 18 and 80 years old. You must have been diagnosed with a specific type of endo-perio disease, and your tooth needs to have a particular type of bone damage that the study aims to fix. Importantly, you must not have smoked any cigarettes or e-cigarettes in the last five years.

There are several reasons why you might not be able to join. For example, if you have severe damage to the tooth that can't be easily repaired, like a broken root, or if you've had root canal treatment or gum surgery on the affected tooth recently. The study also cannot include pregnant or breastfeeding individuals, or those with certain long-term health conditions like uncontrolled diabetes, chronic inflammatory diseases (like severe rheumatoid arthritis), or certain types of cancer. If you're taking specific medications that affect bone healing or your immune system, you might also not be able to participate. They also can't include people with a history of alcohol or drug abuse or those who have had major gum treatment on the affected tooth within the last year.

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 between 18 and 80 years old?
Do you have endo-perio disease diagnosed by a dentist?
Have you been smoke-free (including e-cigarettes) for the last 5 years?
Do you have a specific type of bone damage around your tooth that the study is looking to treat?
Are you pregnant or breastfeeding?
Do you have any major ongoing health conditions like severe diabetes, inflammatory diseases, or cancer?
Are you currently taking medications that affect bone healing or your immune system?

Answer every question to see your result.

What does participation involve?

The study involves a series of dental appointments over several months. First, you'll have an initial check-up to see if you're suitable for the study. If you are, you'll undergo the necessary root canal treatment, followed by a specific gum treatment involving either standard materials or the newer materials with or without L-PRF, depending on which group you are assigned to. This L-PRF is prepared from a small blood sample taken at your appointment. You'll have regular follow-up visits to check on your healing progress, which will likely include X-rays and dental measurements. The full duration of your participation, including all follow-up checks, will be explained by the study team, but typically these kinds of dental studies involve monitoring for at least a year or more.

Potential risks and benefits

Taking part in this study might offer the benefit of receiving advanced dental treatments that could improve healing outcomes for your endo-perio disease. However, as with any medical procedure, there are potential risks, such as discomfort, swelling, or infection after treatment, similar to standard dental work. Using L-PRF involves a blood draw, which carries the small risks associated with taking blood. The study is carefully designed to assess and minimise these risks. You are free to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (1)

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

Guy'S and St Thomas' Nhs Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What is endo-perio disease?

It's a dental problem where both the inside of your tooth (pulp) and the surrounding gums and bone are unhealthy at the same time.

What is L-PRF?

L-PRF is a healing gel made from a small sample of your own blood. It's rich in natural factors that help your body repair and grow new tissue.

Why are different dental materials being used?

The study wants to see if newer root canal filling materials, which are designed to be extra good at sealing and healing, work better than traditional ones.

Will I know which treatment I get?

Because this is a randomised study, you might not know which specific treatment combination you receive until after the study is complete. This helps ensure the results are fair and unbiased.

How long will the study last for me?

The total duration of your involvement, including all treatments and follow-up checks, will be explained by the study team. It typically involves monitoring for at least a year or more after initial treatment.

How to find out more

Sadia Niazi

sadia.niazi@kcl.ac.uk +44 (0) 2071887459 Official trial record

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