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RecruitingNAINTERVENTIONAL

A Study Investigating Gingival Crevicular Fluid Biomarkers Following Use of a Commercially Available Toothpaste Containing Stannous Fluoride

This study aims to understand how a special toothpaste, containing stannous fluoride, helps improve gum health. We're looking for early signs of recovery in the fluid around your gums when you brush with this toothpaste compared to a standard fluoride toothpaste. People with mild gum inflammation, also known as gingivitis, will take part. Participants will brush twice a day for two weeks. The study will help us see if certain natural substances in the gum fluid can show how well your gums are getting better. This information could lead to better ways of measuring gum health and the effects of toothpastes in the future.

At a glance

Status
Recruiting
Phase
NA
Sponsor
HALEON
Enrolment target
20
Start
28 Sep 2026
Estimated completion
01 Nov 2026

What is this study about?

Imagine your gums are a bit inflamed and sometimes bleed when you brush – that’s called gingivitis. This study is all about trying to understand how different toothpastes can help your gums get healthier. We're particularly interested in a toothpaste that contains something called stannous fluoride.

To do this, we'll be looking at tiny amounts of fluid from around your gums, called gingival crevicular fluid. This fluid contains natural substances (biomarkers) that can tell us a lot about how healthy your gums are. The main goal is to see if we can spot early signs of improvement in these markers when people use the special toothpaste, compared to a regular fluoride toothpaste. This could give us a really sensitive way to measure how well a toothpaste works.

Essentially, we want to learn if these specific markers can show us quickly whether a toothpaste is helping your gums recover from gingivitis. This knowledge could be very helpful for developing and testing new oral care products in the future, making sure they are as effective as possible for keeping your gums healthy.

Key takeaways

  • The study explores how a special toothpaste improves gum health.
  • It uses samples of gum fluid to find early signs of improvement.
  • It compares a stannous fluoride toothpaste to a regular fluoride toothpaste.
  • Participants will brush twice daily for two weeks.
  • Aims to find new ways to measure how well toothpastes work for gum health.

Who may be eligible?

To join this study, you need to be generally healthy and between 18 and 70 years old. You should have some mild gum inflammation (gingivitis) and plaque, but your gums shouldn't be too severely affected, and you shouldn't have deep pockets around your teeth. It's important that you're able to come to all the scheduled appointments and follow the study instructions.

There are also some reasons why you might not be able to join. For example, if you've been in another study recently or if you have certain health conditions that could affect your safety or the study results. You also can't take part if you or a close family member works for the company running the study or the research site.

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 between 18 and 70 years old?
  2. Do you have some mild gum inflammation (gingivitis)?
  3. Are you generally healthy and able to attend all appointments?
  4. Have you avoided other clinical studies in the last month?
  5. Do you have a good number of teeth in your upper jaw?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the special test toothpaste or a regular fluoride toothpaste. You'll use this toothpaste to brush your teeth twice a day for two weeks. During this time, you'll have several visits to the study centre. At these visits, the study team will carefully check your gums and collect tiny samples of fluid from around your gums. They will also assess your plaque levels. The entire study duration, from your first visit to your last, will be a few weeks.

Potential risks and benefits

Taking part in this study could help us learn more about gum health and how toothpastes work, potentially benefiting others in the future. As with any study, there's always a small chance of minor discomfort from the gum checks or fluid collection, but these procedures are generally well-tolerated. There are no known serious risks associated with using either toothpaste. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • University of Birmingham
    Verified postcode
    Birmingham, United Kingdom· Recruiting

Common questions

What is gingivitis?

Gingivitis is when your gums become inflamed, often appearing red, swollen, and sometimes bleeding when you brush or floss.

What is stannous fluoride?

Stannous fluoride is an ingredient sometimes found in toothpastes that helps fight against plaque, gingivitis, and tooth sensitivity.

Will I know which toothpaste I'm using?

No, this is a 'blind' study, meaning neither you nor the study team will know which toothpaste you are using until after the study is over. This helps ensure fair results.

What are 'biomarkers'?

Biomarkers are natural substances in your body, like in your gum fluid, that can give us clues about your health or how your body is responding to something.

How long will I be brushing with the study toothpaste?

You will be asked to brush with the study toothpaste twice a day for 14 days (two weeks).

How to find out more

Haleon Response Center

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 "A Study Investigating Gingival Crevicular Fluid Biomarkers F…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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