Not yet recruitingNAINTERVENTIONAL

Inflammation-resolution Therapy in MINST of Periodontal Intrabony Defect: a Pilot Randomised Controlled Trial

We're researching if a new mouthwash, designed to help reduce inflammation, can improve treatment for advanced gum disease. This condition, called periodontitis, causes inflammation and bone loss around teeth, which can lead to tooth loss. The study combines a special deep cleaning method called MINST (Minimally Invasive Non-Surgical Treatment) with either the new mouthwash or a placebo mouthwash. We want to see if using the special mouthwash helps the body 'switch off' inflammation more effectively and leads to better healing. The study will last six months, with seven appointments, to check how well the gums heal and collect samples to understand the healing process in detail.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

Start

01 Nov 2025

Estimated completion

01 May 2027

Periodontal Diseases Periodontitis

What is this study about?

This study is looking into a new way to treat severe gum disease, also known as periodontitis. This condition causes your gums to become inflamed, which can damage the bone that supports your teeth and even lead to tooth loss. We're interested in whether a special mouthwash, which contains an ingredient that helps reduce inflammation, can improve the results of a specific deep cleaning treatment called Minimally Invasive Non-Surgical Treatment (MINST).

MINST is a gentle but thorough deep cleaning that removes harmful plaque from underneath your gum line, which helps to calm down the inflammation. In this trial, we want to find out if using our special mouthwash alongside this deep cleaning helps your body better manage and 'switch off' inflammation, leading to healthier gums. We'll be comparing this special mouthwash to a 'dummy' mouthwash, called a placebo, which doesn't have the active ingredient to reduce inflammation, to see if there's a real difference.

The main goal is to see if, by combining the MINST deep cleaning with this inflammation-reducing mouthwash, we can achieve better healing for your gums. This could mean less gum inflammation, stronger support for your teeth, and ultimately, a healthier mouth. We're hoping to understand precisely how this combination works to improve the healing process.

Key takeaways

The study tests a new mouthwash combined with deep cleaning for severe gum disease.
It aims to improve gum healing by reducing inflammation more effectively.
Participation involves seven appointments over six months at Guy's Dental Hospital.
You will receive either the special mouthwash or a placebo (dummy) mouthwash.
Both clinical checks and samples will be used to track healing progress.

Who may be eligible?

To be part of this study, you need to be between 18 and 70 years old and have a diagnosis of severe gum disease (periodontitis, stage III-IV). You also need to have at least one deep pocket around a tooth or bone defect that is 6mm or more. Your gums should also show more than 30% plaque buildup across all your teeth, and you must be willing to sign a consent form.

There are certain reasons why you might not be able to join. For example, if you've had gum treatment in the area being studied within the last six months, or if you've taken antibiotics within the last three months. Regular use of certain painkillers (NSAIDs) every week, or having certain medical conditions like diabetes, would also prevent you from joining. If you smoke or have smoked in the last five years, or if you're allergic to any ingredients in the study products, you wouldn't be able to take part. Also, if you have diseases affecting your bones or connective tissue, are currently in another clinical study, or are pregnant or breastfeeding, you would not be eligible.

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 70 years old?
Have you been diagnosed with severe gum disease?
Do you have a deep pocket or bone defect around a tooth measuring 6mm or more?
Have you avoided gum treatment in the study area in the last 6 months?
Are you a non-smoker and haven't smoked in the last 5 years?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for six months and involve a total of seven appointments at Guy's Dental Hospital. You will receive the MINST deep cleaning treatment. You'll also be given a mouthwash to use, but neither you nor the study team will know if it's the special mouthwash or a placebo (dummy) mouthwash, as this will be decided randomly. Both mouthwash packages will look the same.

Throughout the study, we will check your gum healing through clinical assessments. We will also collect saliva, blood, and plaque samples at different times. These samples will help us understand more about the healing process and how the deep cleaning and mouthwash combination works. Your commitment to these appointments and sample collections is important for the study's success.

Potential risks and benefits

Taking part in this study could potentially benefit you by helping to improve your severe gum disease, possibly leading to better gum healing and a healthier mouth than with standard treatment alone. However, there's a chance you might receive the placebo mouthwash, which means you might not experience any additional benefits beyond the deep cleaning. As with any medical treatment, there's a small risk of mild side effects from the mouthwash or the deep cleaning procedure, though these are typically minor. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

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

Oral Clinical Research Unit (OCRU) at King's College London (KCL)
Verified postcode
London, United Kingdom

Common questions

What is MINST deep cleaning?

MINST is a special, gentle deep cleaning that carefully removes plaque and bacteria from beneath your gum line to help reduce inflammation.

Will I know if I'm getting the special mouthwash?

No, neither you nor the study team will know if you're receiving the special mouthwash or the placebo. This is to ensure fair and accurate results.

How long will the study last?

The study will last for six months from your starting date, and you will have a total of seven appointments during this time.

Why do you need blood and saliva samples?

These samples help us understand the healing process in more detail and how the combined treatment is affecting your body on a microscopic level.

Can I leave the study if I change my mind?

Yes, you are free to stop participating in the study at any point, and it will not affect your regular dental or medical care.

How to find out more

Luigi Nibali

luigi.nibali@kcl.ac.uk +44 (0)20 7123 4843 Official trial record

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