Not yet recruitingNAINTERVENTIONAL

Evaluation of the Safety and Efficacy of SALI-10 Probiotic Lozenges

This study is testing a new lozenge called SALI-10, which contains a type of 'good' bacteria (a probiotic). We're exploring if this lozenge can help people with common gum problems like gingivitis (early gum disease) and bad breath (halitosis). Gingivitis is caused by plaque build-up, and while brushing helps, we're looking into whether certain helpful bacteria can also play a role. The SALI-10 bacteria might work by reducing swelling in the gums and helping to balance the types of bacteria in your mouth. This could mean fewer harmful bacteria and a healthier mouth overall. We've seen promising results in very early studies, and now we want to understand its safety and how well it works in people.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Ostia Sciences

Enrolment target

Start

01 Apr 2026

Estimated completion

01 Apr 2027

Gingivitis Halitosis

What is this study about?

Gingivitis is a very common gum condition where your gums become red, swollen, and can bleed easily. It's usually caused by a sticky film of bacteria, called plaque, building up on your teeth. While brushing and flossing are really important to get rid of plaque, scientists are also looking into other ways to keep your mouth healthy. One exciting area is using 'good' bacteria, known as probiotics, to help balance the germs in your mouth.

This study is focusing on a specific type of good bacteria called Streptococcus salivarius SALI-10. Researchers believe this bacteria might help your gums in two key ways: first, by directly fighting off some of the 'bad' bacteria that cause gum disease and bad breath; and second, by helping your body's natural defences (your immune system) to reduce swelling and heal the gums. Think of it like adding helpful workers to a team to keep things running smoothly and clean.

We know that a healthy mouth has lots of good bacteria, especially certain types of Streptococcus. When gingivitis starts, these good bacteria can be pushed out by harmful ones. The idea behind SALI-10 is to reintroduce these beneficial bacteria to help restore the natural balance, calm down inflammation, and keep your mouth feeling fresh and healthy. This could offer a new way to support oral health alongside your regular brushing routine.

Key takeaways

This study is testing a probiotic lozenge (SALI-10) for gum health and bad breath.
It aims to see if 'good' bacteria can reduce gum inflammation and balance mouth germs.
The lozenge is taken twice daily for four weeks.
The study includes healthy adults aged 18-70 who don't smoke.
Your safety is a priority, and you can withdraw at any time.

Who may be eligible?

This study is open to healthy men and women aged between 18 and 70. To join, you shouldn't smoke, be currently using certain medications like strong anti-inflammatory drugs or antibiotics, or have certain immune system problems.

There are also some specific dental conditions that would prevent you from taking part, such as having braces, partial dentures that can be removed, or any dental pain at the time of screening. If you're pregnant, breastfeeding, or planning to become pregnant, this study isn't suitable for you.

Women who could become pregnant and are taking part will need to use effective birth control throughout the study. We also need to check that you haven't recently had any surgery or have any upcoming operations, particularly dental ones.

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?
Do you not smoke?
Are you generally healthy, with no major ongoing illnesses?
Do you currently have no dental pain, braces, or removable partial dentures?
Are you not pregnant, breastfeeding, or planning to become pregnant? (If female and able to get pregnant, are you willing to use reliable birth control?)

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given a special lozenge that you'll need to take twice a day – once in the morning and once in the evening, after you've brushed your teeth and scraped your tongue. This will involve placing the lozenge in your mouth and letting it dissolve. You'll need to do this for a total of four weeks.

Throughout the study, you'll have regular visits to the clinic so the research team can check on your oral health. This will include looking at your gums and potentially taking samples to see how the bacteria in your mouth are changing. We'll also ask you about any symptoms you might have. The total duration of your active participation, including initial checks and follow-up, will be clearly explained during the screening process.

Potential risks and benefits

Participating in this study might offer some potential benefits, as the SALI-10 lozenge could help improve your gum health and reduce bad breath. However, as with any study, there are no guarantees it will help you personally. There might be some minor risks, such as mild discomfort or a reaction to the ingredients, which we will carefully monitor. Your safety is our top priority, and you'll be able to discuss any concerns with the study team. Remember, you can choose to leave the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

OMGPerio
Verified postcode
Hamilton, Canada

Common questions

What is gingivitis?

Gingivitis is an early and common form of gum disease where your gums become red, swollen, and might bleed easily. It's usually caused by plaque buildup on your teeth.

What is a probiotic?

A probiotic is a 'good' type of bacteria that can offer health benefits, often by helping to balance the other bacteria in your body, like in your mouth or gut.

Will I know if I'm getting the real lozenge or a dummy one?

No, this is a 'blinded' study, meaning neither you nor the researchers will know who is receiving the SALI-10 lozenge and who is receiving a placebo (a dummy lozenge) until after the study is complete. This helps ensure fair results.

How often do I take the lozenge?

You will take one lozenge twice a day, in the morning and evening, after brushing your teeth and cleaning your tongue, for a period of four weeks.

What is halitosis?

Halitosis is the medical term for bad breath, which can be caused by various factors, including certain types of bacteria in the mouth.

How to find out more

Mark Kwiecinski, P.Eng, M.Sc Physics

mark@pmkengineering.com 1-613-513-4413 Official trial record

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