SALI-10 Oral Probiotics for Gum Disease

Overseen By Mark Kwiecinski, P.Eng, M.Sc Physics

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ostia Sciences

Must not be taking: Antibiotics, Anti-inflammatories

Disqualifiers: Orthodontic bands, Dentures, Tumours, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral probiotic called SALI-10 to determine its effectiveness in preventing gum disease, specifically gingivitis. Gingivitis, a common issue, arises from plaque buildup that causes gum inflammation. The trial aims to assess whether SALI-10 can maintain a healthy balance of oral bacteria, reduce harmful bacteria, and support gum health. It seeks participants with healthy gums, no history of gum disease, non-smokers, and those with at least 20 teeth. Participants should not use certain medications or products that affect the gums. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in oral health.

Do I need to stop my current medications to join the trial?

Yes, you will need to stop taking any anti-inflammatory, antibiotics, or antimicrobial drugs at least 30 days before joining the trial. Additionally, you cannot be on long-term antibiotic or anti-inflammatory therapy, or use medications that could affect the gums.

Is there any evidence suggesting that SALI-10 is likely to be safe for humans?

Research shows that the probiotic Streptococcus salivarius SALI-10 is generally safe for humans. Studies indicate that antibiotics can treat this strain, meeting safety standards for probiotics. Previous research on similar types of S. salivarius also supports the safety of SALI-10. These findings suggest that SALI-10 is well-tolerated and suitable for helping prevent gingivitis (gum disease). ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for gum disease, which often involve antimicrobial rinses or surgical procedures, SALI-10 is an oral probiotic lozenge containing 6 billion CFUs. This treatment is unique because it leverages beneficial bacteria to naturally balance the oral microbiome, potentially reducing harmful bacteria that cause gum inflammation. Researchers are excited about SALI-10 because it offers a non-invasive approach that could improve oral health by promoting a healthier bacterial environment in the mouth, which is a novel mechanism compared to traditional methods.

What evidence suggests that SALI-10 might be an effective treatment for gum disease?

Research shows that probiotics like SALI-10, which participants in this trial may receive, might help improve gum health. Studies have found that certain probiotics can enhance oral health by reducing bleeding and altering bacterial levels. The specific probiotic in SALI-10, S. salivarius, produces a natural substance called salivaricin, which combats harmful bacteria. This action helps maintain a healthy bacterial balance in the mouth, potentially reducing swelling and preventing gum diseases like gingivitis. Early results suggest that these probiotics could effectively manage gum problems. ^{1 3 5 6 7}

Who Is on the Research Team?

Dr. Michael Goldberg, MDM

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for adults with gum disease who have not used antibiotics or probiotics recently, do not smoke, and are not pregnant. Participants must be willing to avoid dental cleanings during the study and follow specific oral hygiene practices.

Inclusion Criteria

Absence of Periodontal Pockets, Probing Depth (PD) < 3.0 mm on all teeth/site

Absence of Clinical Attachment Loss (CAL) = 0 mm

Non-smokers

Exclusion Criteria

Presence of orthodontic bands

Presence of partial or full dentures

History of allergy to a consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo an oral exam and biospecimen collection, receive a dental cleaning, and are assigned study products

1 day

1 visit (in-person)

Pre-Induction

Participants consume lozenges and attend study visits for oral examination and biospecimen collection

2 weeks

2 visits (in-person)

Induction Phase

Participants refrain from all oral hygiene for 21 days while continuing their assigned lozenges

3 weeks

3 visits (in-person)

Resolution Phase

Participants resume oral hygiene and continue study lozenges, with oral examination and biospecimen collection

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SALI-10

Trial Overview The trial tests SALI-10, a strain of Streptococcus salivarius that produces Salivaricin 10. It's thought to help maintain healthy bacteria in the mouth, inhibit harmful ones, and prevent inflammation associated with gingivitis.

How Is the Trial Designed?

Group I: Placebo Active Control 1 Intervention

Placebo lozenges used

Group II: SALI-10 Active Control 1 Intervention

Lozenges containing 6B CFUs of

Who Is Running the Clinical Trial?

Ostia Sciences

Lead Sponsor

Trials

1

Recruited

10+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07256743

Efficacy of SALI-10 Oral Probiotics in Experimental Gingivitis Male or female volunteers aged 18-70 years · In good general health, ASA I · No clinical signs of gingival inflammation at >90% of sites observed ...

2. withpower.com withpower.com/trial/early-phase-1-oral-health-2-2025-72807

Probiotic Lozenges for Oral Hygiene · Info for Participants This trial tests a new probiotic lozenge made from S. salivarius SALI-10, which may improve oral health by balancing mouth bacteria.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10534711/

The Benefits of Probiotics on Oral Health: Systematic Review ... Kang et al. (2020) found that probiotics improved periodontal health in adults, with reduced bleeding and altered oral bacteria levels [38].

4. mdpi.com mdpi.com/2673-8007/5/1/14

A New Frontier in Oral Care: Live Streptococcus salivarius ... Studies have shown that probiotic toothpaste can be as effective as conventional fluoride toothpaste in reducing plaque and gingivitis, the early stages of gum ...

5. cda-adc.ca cda-adc.ca/jcda/vol-75/issue-8/585.pdf

Probiotics for Oral Health: Myth or Reality? Although only a few clinical studies have been conducted so far, the results to date suggest that probiotics could be useful in preventing and treating oral ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40946775/

Comprehensive safety assessment of the probiotic ... SALI-10 demonstrated susceptibility to clinically relevant antibiotics, ensuring compliance with probiotic safety standards. Additional ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/43/NCT07256743/Prot_ICF_000.pdf

Clinical Trial Study Protocol We propose using a novel strain, Streptococcus salivarius SALI-10, as a targeted microbial intervention to modulate the oral microbiome and prevent gingivitis. ...