Recruiting

S. Salivarius SALI-10

Sponsor:

Ostia Sciences

Code:

NCT07508839

Conditions

Gingivitis

Halitosis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

3B SALI-10 Lozenge

Placebo

Study Details

Brief summary:

Gingivitis is among the most common oral conditions, affecting 50-90% of adults globally. It is a reversible inflammatory disease triggered primarily by the accumulation of microbial plaque on teeth and gingival tissues. Standard treatment involves plaque reduction and maintenance of oral hygiene, often supplemented with antimicrobial therapeutics to prevent disease progression. While plaque control remains the cornerstone of prevention, emerging research points to certain beneficial microbes that may protect gingival health. Notably, Streptococcus species have been associated with both antimicrobial and anti-inflammatory activities, suggesting their potential as oral probiotics.

Recent investigations have focused on a novel strain, Streptococcus salivarius SALI-10, which produces a lantibiotic called Salivaricin 10. This peptide exhibits unique immunomodulatory properties. In murine models, Salivaricin 10 was shown to enhance neutrophil recruitment and activity while directing monocytes toward the M2 pro-resolution macrophage phenotype, a cell population integral to tissue repair and late-stage wound healing. Such effects highlight the potential of SALI-10 to reduce gingival inflammation while fostering microbial balance.

The concept of employing S. salivarius strains in oral health is not entirely new. Other variants isolated from the oral cavities of healthy individuals produce lantibiotics with lanthionine or β-methyllanthionine residues that demonstrate antimicrobial effects against pathogens. Clinical investigations have explored these probiotic strains for halitosis, plaque control, and gingivitis, reporting safety and efficacy. Moreover, salivaricin-producing strains are considered valuable in the ongoing search for alternatives to conventional antibiotics in light of increasing resistance.

Understanding the microbial ecology of gingivitis helps contextualize this therapeutic potential. In health, gram-positive bacteria, particularly Streptococcus species, dominate the oral microbiome. Gingivitis involves a shift toward gram-negative periopathogens such as Porphyromonas, Tannerella, Treponema, and Prevotella. This dysbiosis provokes an inflammatory cascade characterized by neutrophil infiltration, tissue damage, and, if unresolved, progression to periodontitis. A recent human experimental gingivitis study revealed distinct host response phenotypes. Participants retaining beneficial Streptococcus species, such as S. sanguinis and S. oralis, experienced reduced periopathogen emergence and milder inflammation. By contrast, participants who lost these protective bacteria demonstrated greater inflammatory severity, underscoring the critical role of Streptococcus persistence in oral homeostasis.

Neutrophils, the most abundant immune cells in periodontal tissues, are central to this dynamic. Their numbers increase proportionally with gingivitis severity. Importantly, Health Canada has recently recognized salivary neutrophil activity as a valid biomarker for assessing inflammatory burden and risk of gingivitis or periodontal disease. This regulatory approval highlights the growing emphasis on immune function as both a diagnostic measure and therapeutic target in oral health.

Against this backdrop, S. salivarius SALI-10 presents a compelling intervention strategy. Its hypothesized benefits include reducing inflammation via promotion of the M2 macrophage phenotype, suppressing periopathogen growth through competitive exclusion and Salivaricin 10 production, and mitigating halitosis by blocking volatile sulfur compound-producing bacteria. To evaluate these benefits, a proposed study design involves administering a twice-daily lozenge , one in the morning and one in the evening, after brushing a tongue scraping each containing 3 billion CFU of SALI-10 over a four-week period.

In summary, gingivitis remains highly prevalent but reversible. Beyond traditional hygiene approaches, microbial therapeutics such as S. salivarius SALI-10 may offer a dual antimicrobial and anti-inflammatory benefit. By promoting immune resolution and reshaping the microbial community, SALI-10 could emerge as a novel probiotic strategy in maintaining oral health and addressing the limitations of conventional antimicrobial therapies.

Conditions

Gingivitis

Halitosis

Study ID

NCT07508839

Start date

May 4, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female volunteers aged 18-70 years
2. In good general health, ASA I
3. Non-smokers
4. Fluent in English
5. For sexually active volunteers of childbearing potential, one of the following methods must be used to prevent pregnancy during the study by participants.

1. Post-menopausal
2. hormonal birth control (oral, injectable, transdermal, intra-vaginal) or intrauterine device must be in use at least 30 days prior to first study drug administration;
3. barrier methods must be in use at least 14 days prior to study drug administration;
4. that vasectomy on the male partner must be completed 3 months prior to first study drug administration;
5. or in the alternative that a 0 sperm count for the male partner will suffice

Exclusion Criteria:

1. Presence of orthodontic bands.
2. Presence of partial removal dentures.
3. Dental pain at time of screening.
4. History of allergy to a consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study, or to any of the following: sorbitol, isomalt, dibasic calcium phosphate, potato or potato starch, mint or mint flavour, glyceryl dibehenate, steviol glycosides.
5. Participation in any other clinical study or test panel within one month before entering the study.
6. Current use of anti-inflammatory, antibiotics, or antimicrobial drugs or within the last 30 days of enrolment.
7. Those taking anticoagulant medications and have blood and bleeding disorders
8. Those who have recently experienced (past 30 days) or will be experiencing (next 90 days) dental, oral, or any type of surgery
9. History of systemic inflammatory or immune conditions or immunocompromised conditions
10. Pregnant or nursing women or those planning on getting pregnant.
11. Use of tobacco products.
12. Long-term antibiotic or anti-inflammatory therapy.
13. Medical condition or any current usage of medication that the investigator considers may compromise the subject's safety as well as the quality of the study results (note, only Advil and Tylenol are allowed during the study for analgesia)
14. Medication or Natural Health Products (NHPs) that could affect the gingiva like calcium channel blockers, anti-epileptic therapy etc.
15. Participants who are experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain.
16. Presence of active infections
17. Use of any probiotic
18. Use of anti-plaque/anti-gingivitis products
19. Subjects who must receive dental treatment during the study elates
20. Concurrent orthodontic treatment
21. Untreated carious lesions and/or inadequate restorations on maxillary posterior teeth
22. Periodontal disease (periodontal pockets, probing depth (PD) < 3.0 mm on at least one tooth/site, presence of Clinical Attachment Loss (CAL) = 0 mm, or periodontal disease history)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

This arm will receive lozenges without the active ingredient

active comparator: SALI-10

This arm will receive lozenges containing the active ingredient (3B CFUs of SALI-10)

Interventions

3B SALI-10 Lozenge

A lozenge containing 3B CFUs of the probiotic . S. salivarius SALI-10

Placebo

It is a placebo lozenge with no active ingredient.

Primary outcome measure

  • Reduction of gingival inflammation between the probiotic and placebo groups determined by bleeding on probing (BOP) [ Time Frame: 81 days ]
  • Reduction of gingival inflammation between the probiotic and placebo groups determined by oral inflammatory load [ Time Frame: 81 days ]
  • Number of patients with treatment-related adverse events of twice-daily SALI-10 lozenge using an end of study questionnaire [ Time Frame: 81 days ]

Central Contacts and Locations

Central contacts

Mark Kwiecinski, P.Eng, M.Sc Physics

1-613-513-4413Mark@PMKengineering.com

Locations

OMGPerio

Recruiting

Hamilton, Ontario, Canada, L8N 1K4

Contacts

Dr. Alon Borenstein, MDM, MSc Periodontology

(905) 923-5185reception@omgperio.ca

Principal Investigator:

Dr. Alon Borenstein, MDM, MSc Periodontology

More Information

Sponsor

Ostia Sciences

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Oral Health
  • Probiotics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ostia Sciences on 2026-08-20.