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RecruitingNAINTERVENTIONAL

A Pilot Study to Test the Efficacy of a Commercial Toothpaste (Cosmetic Product)

This study is looking at how well a new toothpaste works for people with gum disease, also known as periodontitis. It's a type of toothpaste you might use every day. The toothpaste contains a new ingredient that might help keep the healthy germs in your mouth balanced. We want to see if using this toothpaste twice a day for three months can make a difference in your gum health. The study will involve people who already have regular dental cleanings for their gum disease, and it will be carried out at different locations.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Periotrap Pharmaceuticals GmbH
Enrolment target
28
Start
28 Jul 2025
Estimated completion
31 Jul 2026

What is this study about?

This study is a research project designed to see if a specific toothpaste can help people who have a common gum condition called periodontitis. Periodontitis is a serious form of gum disease which, if left untreated, can lead to tooth loss. You might already be getting regular teeth cleaning to help manage your periodontitis, and this study will look at how using a particular toothpaste might add to that care.

The research teams want to find out if this toothpaste, which contains a new, special ingredient, can protect the good bacteria in your mouth. Think of it like trying to keep a garden healthy by encouraging the helpful insects. A balanced set of bacteria in your mouth (what we call a 'microbiome') is really important for healthy gums. If this toothpaste works well, it could become another tool to help people manage their gum health.

It's important to remember that this is a 'pilot study', which means it's one of the first steps in testing this new toothpaste. The aim is to see if it's promising enough to do more research in the future. Everything will be done carefully, with your safety and well-being as the top priority.

Key takeaways

  • This study tests a new toothpaste for gum disease (periodontitis).
  • It contains a special ingredient to help maintain healthy mouth bacteria.
  • Participation involves using the toothpaste twice daily for three months.
  • It's for adults 18+ who already receive regular dental cleanings for gum disease.
  • The goal is to see if this toothpaste is effective for future gum health.
  • Your safety and well-being are the top priorities throughout the study.

Who may be eligible?

To join this study, we're looking for adults aged 18 or over. You need to be in generally good health and understand what the study involves. It's important that you have at least 16 of your own natural teeth and that you already have professional dental cleanings for your gum disease once or twice a year.

There are also some reasons why you might not be able to join. For example, if you're involved in another medical study or if you have certain serious health conditions like heart problems, diabetes, or liver disease, you might not be eligible. We also can't include people who work directly on the study to make sure everything is fair and unbiased.

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. Do you have at least 16 of your own natural teeth?
  3. Do you regularly get professional teeth cleaning for your gum disease (once or twice a year)?
  4. Are you generally in good health?
  5. Are you currently not involved in another medical research study?
  6. Do you not have serious uncontrolled health conditions like heart disease or diabetes?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to use the special study toothpaste twice a day for three months. You'll need to brush your teeth as you normally would. During the study, you'll have some appointments at the clinic so the researchers can check on your gum health and make sure you're doing well. The total time you'd be involved in the study is three months. Before you start, you'll have an initial visit to make sure you're suitable for the study and to explain everything in detail.

Potential risks and benefits

The main benefit of taking part is that you would be contributing to scientific research that could help improve treatments for gum disease in the future. You'd also receive careful monitoring of your oral health during the study. As this is a toothpaste, serious risks are not expected, but like with any product, there's always a small chance of an unexpected reaction. Your safety is our top priority, and you'll be monitored closely. Remember, joining this study is completely your decision, and you can choose to leave it at any time without giving a reason, and it won't affect any future medical care you receive.

Locations (3)

  • Dr. Hofmann
    Verified postcode
    Bietigheim-Bissingen, Germany· Not yet recruiting
  • Dr. T. Schütz
    Verified postcode
    Borna, Germany· Recruiting
  • Dr. G. Jungbauer
    Verified postcode
    Straubing, Germany· Recruiting

Common questions

What is periodontitis?

It's a serious form of gum disease that can cause your gums to pull away from your teeth, and if not treated, can lead to tooth loss.

What does 'eubiotic oral microbiome' mean?

It refers to having a healthy balance of good bacteria and other tiny living things in your mouth, which is important for your overall oral health.

Will I know if I'm using the special toothpaste or a regular one?

No, to make sure the study results are fair, you won't know which toothpaste you're using. This is a common practice in research studies.

How long will I have to use the toothpaste?

You will be asked to use the study toothpaste twice a day for a total of three months.

What if I decide I don't want to continue with the study?

You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

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 "A Pilot Study to Test the Efficacy of a Commercial Toothpast…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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