Good bacteria lozenge aims to stop bleeding gums
NCT ID NCT07256743
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a daily probiotic lozenge (SALI-10) can prevent gingivitis, a common gum disease that causes bleeding and inflammation. About 60 healthy adults will stop brushing for a short period to allow plaque buildup, then take either the probiotic or a placebo. The main goal is to see if the probiotic reduces gum bleeding compared to placebo.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female volunteers aged 18-70 years 2. In good general health, ASA I 3. No clinical signs of gingival inflammation at \>90% of sites observed 4. Absence of Periodontal Pockets, Probing Depth (PD) \< 3.0 mm on all teeth/site 5. Absence of Clinical Attachment Loss (CAL) = 0 mm 6. No periodontal disease history 7. Have at least 20 gradeable teeth 8. Non-smokers 9. Fluent in English 10. For study participants of childbearing potential, both men and women, at least one of the following birth control measures must be used: abstinence, hormonal birth control (oral, injectable, transdermal, intra-vaginal), intrauterine devices, confirmed successful vasectomy, or condoms. Exclusion Criteria: 1. Presence of orthodontic bands. 2. Presence of partial or full dentures. 3. Tumour(s) of the soft or the hard tissues of the oral cavity. 4. Cavitated carious lesions requiring immediate restorative treatment. 5. History of allergy to a consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study. 6. Participation in any other clinical study or test panel within one month before entering the study. 7. Medical condition which requires pre-medication before dental visits/procedures 8. Current use of anti-inflammatory, antibiotics, or antimicrobial drugs or within the last 30 days of enrolment. 9. History of periodontal disease. 10. History of systemic inflammatory, immune conditions and immunocompromised conditions 11. Pregnant or nursing women or those planning to get pregnant 12. Use of tobacco products. 13. Long-term antibiotic or anti-inflammatory therapy. 14. Medication or Natural Health Products (NHPs) that could affect the gingiva like calcium channel blockers, anti-epileptic therapy etc. 15. Medical condition or any current usage of medication that the investigator considers may compromise the study participant's safety as well as the quality of the study results 16. Allergy to any of the following ingredients: Streptococcus Salivarius, Sorbitol, Isomalt, Calcium phosphate dibasic, Potato starch, Mint, Glyceryl dibehenate, Stevia, Maltodextrin 17. Use of other probiotics 18. Taking anticoagulant medications and those suffering from blood and bleeding disorders 19. Recently experienced or will be experiencing dental, oral or any type of surgery. 20. Use of anti-plaque/ anti-gingivitis products 21. Presence of active infections 22. Participants who are experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain. 23. Use of any antibiotics.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Toronto
RECRUITINGToronto, Ontario, M5G 1G5, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Electric flosser may tackle plaque and gum bleeding better than brushing alone
- Braces vs. clear aligners: which is gentler on your gums?