SALI-10 probiotic lozenge for preventing gingivitis

A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy SALI-10 Oral Probiotics in Experimental Gingivitis

This will test whether daily SALI-10 oral probiotic lozenges can reduce plaque-driven gingival inflammation in healthy adults using the experimental gingivitis model.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Ostia Sciences (industry)
• Drugs / interventions: cyclophosphamide
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT07256743 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial tests SALI-10 oral probiotic lozenges in an experimental gingivitis (EG) model to provoke and then monitor reversible gingival inflammation. Eligible healthy adults will abstain from routine oral hygiene for a defined EG period and follow the dosing regimen for SALI-10 while investigators measure clinical gingival and plaque indices. The protocol also includes collection of microbiological and inflammatory markers to track shifts in oral microbial ecology and neutrophil-associated responses. The work is sponsored by Ostia Sciences with clinical operations at the University of Toronto.

Who should consider this trial

Good fit: Healthy adults aged 18–70 who are non-smokers, have at least 20 natural teeth, show minimal baseline gingival inflammation, and can attend visits at the Toronto site are ideal candidates.

Not a fit: People with existing periodontal disease, orthodontic bands, partial or full dentures, active oral tumors or cavitated caries needing treatment, smokers, or those allergic to product ingredients are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, SALI-10 lozenges could help reduce plaque-related gum inflammation and support quicker return to gingival health during lapses in oral hygiene.

How similar studies have performed: Prior small trials of oral probiotics have reported modest reductions in plaque and gingival inflammation, but using the experimental gingivitis model with SALI-10 represents a relatively novel application.

Eligibility criteria

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.

Where this trial is running

Toronto, Ontario

• University of Toronto — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Dr. Michael Goldberg, MDM — University of Toronto
• Study coordinator: Mark Kwiecinski, P.Eng, M.Sc Physics

Conditions: Gingivitis, Probiotic, Oral Health, Lozenge