RecruitingNAINTERVENTIONAL

Periodontal Health and Sodium Bicarbonate Toothpaste

This study is exploring if a fluoride toothpaste containing sodium bicarbonate can help adults maintain healthy gums after having professional gum treatment. Researchers will measure different aspects of oral health, like plaque and bleeding gums, and look at spit samples and the germs in people's mouths. Participants will use either the special toothpaste or a dummy (placebo) toothpaste, along with regular dental hygiene instructions and cleanings over six months. The aim is to understand if this specific toothpaste makes a difference in preventing gum disease from returning after initial treatment.

At a glance

Status

Recruiting

Phase

Sponsor

University of Plymouth

Enrolment target

100

Start

04 Dec 2024

Estimated completion

30 Jan 2027

Periodontal Diseases

What is this study about?

This research study, called "Periodontal Health and Sodium Bicarbonate Toothpaste," is all about understanding how to keep your gums healthy, especially after you've had a deep cleaning for gum disease. Gum disease can cause problems like bleeding gums and loose teeth if not looked after, so finding good ways to keep it at bay is important.

The main idea is to see if using a special fluoride toothpaste that contains something called sodium bicarbonate (which is like baking soda) can really make a difference. We want to know if it helps people keep their gums healthier once they've already had non-surgical treatment for gum disease, like scaling and root planing. This study is trying to work out if adding this toothpaste to your daily routine can help stop gum problems from coming back, by looking at things like how much plaque you have, if your gums bleed, and how deep any gum pockets are.

Throughout the study, the researchers will also be looking at other things. They'll check your spit for certain markers and even study the types of germs living in your mouth to see if the toothpaste changes them. This helps them get a complete picture of how the toothpaste might be working, or not working, to improve your overall mouth health. The study will last for six months, with check-ups at the beginning, three months, and six months.

Key takeaways

This study investigates if a special toothpaste helps gum health after deep cleaning.
Participation involves free dental check-ups and cleanings for six months.
You'll use either the study toothpaste or a regular one without knowing which.
Researchers will check plaque, bleeding gums, spit, and mouth germs.
All dental care mentioned is provided by the research team.
You can leave the study at any time without affecting your dental care.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or over. Both men and women are welcome to take part. You'll be one of around 100 people joining from patients seen at the Peninsula Dental School in Plymouth.

There are certain reasons why you wouldn't be able to join. For example, if you have diabetes (type 1 or 2), have had cancer, or are pregnant, you wouldn't be eligible. Also, if you use full dentures, have taken antibiotics or certain other medications (like immunosuppressants) recently, or used antibacterial mouthwash in the last three months, you wouldn't be able to participate. They'll also check your gum health carefully, and if your gum scores are too low or too high, you might not be suitable.

It's important that your dental care isn't currently being handled by students at the dental school, as this study has its own dedicated research team to provide your dental check-ups and treatments.

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?
Do you currently have gum disease that needs treatment?
Have you NOT had diabetes, cancer, or are you NOT pregnant?
Have you NOT taken antibiotics or certain other medications in the last 3 months?
Are you NOT using full dentures or antibacterial mouthwash regularly?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved for a total of six months. At the very beginning, you'll have a thorough dental check-up. Over the six months, you'll have three planned visits with a dental hygienist. Depending on what your teeth and gums need, you might also have extra dental appointments, all provided by the research team. These appointments will involve a deep cleaning of your teeth, both above and below the gum line, by qualified hygienists.

You'll be given either the special fluoride toothpaste with sodium bicarbonate or a standard (placebo) toothpaste to use daily. You won't know which one you're using. During your visits, your oral health will be carefully checked – this includes looking at things like plaque, gum bleeding, and the depth of your gum pockets. They will do these checks at the start, at three months, and again at six months. You'll also receive advice on how to keep your mouth clean at home. All dental treatments needed will be provided by the research team, completely separate from any student treatment schedules.

Potential risks and benefits

Participating in this study could offer some potential benefits, such as receiving free dental check-ups and professional gum cleanings from experienced hygienists for six months. You'll also get advice on improving your daily dental routine. There might be no direct benefit to you personally, as the toothpaste might not make a difference, or you might receive the placebo. As with any dental treatment, minimal risks like temporary gum sensitivity could occur. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual dental care.

Locations (1)

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

Derriford Dental Education Facility
Verified postcode
Plymouth, United Kingdom· Recruiting

Common questions

What is 'periodontal health'?

Periodontal health refers to the health of your gums and the bone that supports your teeth. Good periodontal health means no gum disease.

What does 'non-surgical periodontal treatment' mean?

This is a deep cleaning of your teeth and gums, usually called 'scaling and root planing,' that helps remove plaque and tartar below the gum line without needing surgery.

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

No, you won't know. You'll be given either the special toothpaste or a dummy (placebo) toothpaste. This helps ensure the study results are fair.

How long will I be part of the study?

You'll be involved in the study for a total of six months. You'll have check-ups at the start, at three months, and at six months.

What does 'oral hygiene instruction' involve?

You'll receive guidance and tips from dental professionals on the best ways to brush and clean your teeth at home to keep your mouth healthy.

How to find out more

Zoe Brookes, BDS, MJDF, PCHE, SFHEA, PhD

zoe.brookes@plymouth.ac.uk 01752 586828 Official trial record

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