Ongoing, recruitingTherapeutic use (Phase IV)Interventional

High-dosage fluoride toothpaste for root caries control (in situ): a randomized, controlled clinical trial

This research investigated whether a high-strength fluoride toothpaste could effectively prevent or even reverse tooth decay on the roots of teeth. Instead of using people's teeth directly, the study used small samples of cow's teeth that were placed inside people's mouths for a short time. This allowed scientists to safely observe the effects of the toothpaste. They wanted to see if the fluoride could lead to more minerals being added back into the tooth, making it stronger against decay, or if it could stop mineral loss. The toothpaste being tested contained 1,450 parts per million (ppm) of fluoride, which is a higher amount than many standard toothpastes.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Aarhus University

Enrolment target

Start

31 Oct 2022

Phenomena and Processes (Fluoride in dental caries control)

What is this study about?

This study is looking into how a special, stronger fluoride toothpaste can help protect the roots of your teeth from decay. As we get older, our gums can sometimes pull back a little, exposing the softer root part of the tooth. This exposed root is more vulnerable to decay than the hard, enamel-covered crown of your tooth. Fluoride is a natural mineral that dramatically helps make teeth stronger and more resistant to acid attacks that cause decay.

The researchers set up a clever way to test this. Instead of directly applying the toothpaste to people's teeth and waiting a long time, they used small, flat pieces of cow's teeth. These pieces were made to be like the root surface of a human tooth. They were then carefully placed in a removable device inside the mouths of volunteers. This allowed the scientists to test the toothpaste in a real mouth environment, but on tooth samples rather than on the volunteers' own teeth. They then measured how much mineral was lost from these tooth samples or how much was gained after using the special toothpaste.

They also looked at how much fluoride from the toothpaste ended up in the volunteers' saliva and in the thin layer of germs (biofilm) that forms on teeth. This helps them understand how the fluoride works to protect the teeth. The toothpaste used in this study had 1,450 parts per million (ppm) of fluoride, which is considered a high dose, usually prescribed by a dentist for people at higher risk of decay. This type of research is important because it can help dentists understand the best ways to keep your teeth healthy, especially as we age.

Key takeaways

This study investigated a high-strength fluoride toothpaste to prevent or reverse root decay.
Small cow's tooth samples were used and placed in volunteers' mouths for testing.
The toothpaste contained 1,450 parts per million (ppm) of fluoride.
Researchers measured mineral changes in teeth and fluoride levels in saliva and mouth film.
The aim is to find better ways to protect teeth roots from decay.
It's a 'Phase IV' study, meaning it looks at how an existing treatment works in practical use.

Who may be eligible?

To join this study, participants generally need to be adults, specifically aged 18 years or older. There is no upper age limit, so people of many different ages can take part. Both men and women are welcome to participate in this research.

The study needed healthy volunteers who were able to comfortably wear a special device in their mouth for a short period. This device held small pieces of experimental tooth material for the test.

More specific details about health conditions or medications that might prevent someone from joining would be explained by the study team. For example, conditions that affect your mouth health might be important.

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 18 years old or older?
Are you comfortable wearing a small device in your mouth for a short period?
Are you generally healthy?
Are you willing to use a specific toothpaste as instructed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have an initial visit where your eligibility is checked and the study is fully explained. You would then be asked to wear a small, custom-made device in your mouth for a specific period. This device would contain the special tooth samples that the researchers are studying. You would be given the specific high-fluoride toothpaste to use as instructed during this time.

Throughout the study period, you might have several visits to the clinic. During these visits, the research team would collect the tooth samples for analysis, and possibly take samples of your saliva and the film from the tooth samples. They would also check how you are doing and answer any questions you have. The total duration of participation for this type of short-term study would typically be for a few weeks or perhaps a couple of months at most, but exact timings would be provided by the study team.

Potential risks and benefits

Potential benefits of taking part in this study include contributing to important scientific knowledge that could help dental health for many people in the future. You might also receive expert dental care and monitoring during your participation. Potential risks are generally low; wearing the oral device might feel a little unusual at first, and some people can be sensitive to higher fluoride toothpastes, although this is usually mild and temporary. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care, and without needing to give an explanation.

Locations (1)

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

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Unverified
Denmark

Common questions

What is 'root caries'?

Root caries is another name for tooth decay that happens on the root surface of your tooth, usually when the gum line has receded a bit.

Why did they use cow's teeth instead of human teeth?

Using cow's teeth allowed researchers to safely and ethically test the toothpaste in a real mouth environment without causing any permanent changes or damage to a person's own teeth. It's a common method in dental research.

Is the toothpaste used in this study the same as my regular toothpaste?

No, this study used a high-strength fluoride toothpaste with 1,450 parts per million (ppm) fluoride, which is stronger than many regular toothpastes you buy in a shop. It's often prescribed by a dentist.

What does 'in situ' mean in the study title?

''In situ' means 'in its original place' or 'in the natural environment'. In this study, it means the tooth samples were placed inside a volunteer's mouth to experience real-life conditions.

Will I get to keep the special toothpaste after the study?

The study team will provide all necessary materials, but typically, study-specific medications or products are for the duration of the trial only.