An interventional study of 3B SALI-10 Lozenge and Placebo in Gingivitis and Halitosis, sponsored by Ostia Sciences. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Ostia Sciences · Not applicable, Interventional, and Treatment
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.
Gingivitis is an oral disease condition affecting 50% to 90% of adults globally. The gingivitis pathology can be reversed by reduction or removal of microbial plaque that accumulates on hard and soft tissues and is considered standard of care in the industry. Regular oral hygiene in combination with therapeutics that deliver an anti-microbial benefit is thought to mitigate the onset of gingivitis. However, some oral microbes, specifically Streptococcal species, have been identified with both antimicrobial and anti-inflammatory attributes that are speculated to play a role in protecting and potentiating healthy gingival tissues and are currently being investigated as probiotic opportunities in oral health support.
Recently, a new strain of Streptococcus salivarius SALI-10 has been identified with unique lantibiotic (Salivaracin 10) production that highlights a possible anti-inflammatory benefit. Using a mouse model, S. salivarius SALI-10 isolated Salivaracin 10 was shown to increase neutrophil recruitment and activation while also driving monocyte differentiation toward an M2 pro-resolution macrophage phenotype, widely found to participate in the oral cavity and late stages of the wound healing response. Other studies have shown certain Streptococcus salivarius strains, found in the oral cavity of healthy patients, produce similar lantibiotic salivaricins containing lanthionine and/or β-methyllanthionine residues. These molecules have been found to promote antimicrobial activity towards relevant oral pathogens and have been applied through the development of salivaricin-producing probiotic strains. Indeed, several groups have investigated the efficacy of different Streptococcus salivarius probiotic strains with success in halitosis, safety, plaque and gingivitis clinical trials. These salivaricins may also prove to be of great value in the development of new and novel antibacterial therapies in this era of emerging antibiotic resistance.
Gingivitis is a reversible inflammatory condition caused by the accumulation of dental plaque and the associated disruption of the host-microbial homeostasis. During gingivitis, the microbial community transitions from being dominated by gram-positive health-associated bacteria, such as Streptococcus species, to gram-negative periopathogens, including species of the genera Porphyromonas, Tannerella, Treponema and Prevotella. This dysbiotic shift triggers inflammatory responses, subsequent increase in neutrophils, leading to tissue damage and, in some cases, progression to periodontitis.
A recent study on human experimental gingivitis identified three distinct host response phenotypes.The microbial analysis revealed that the persistence of beneficial Streptococcus species, such as S. sanguinis and S. oralis, in slow and low responders correlated with a protective effect against the emergence of periopathogens and the associated inflammatory cascade. Conversely, the loss of these beneficial bacteria in high responders was linked to more severe inflammation, highlighting the critical role of the oral microbiome in modulating gingivitis severity.
Alterations in the oral microbiome alter host immune functions and stimulate immune cells to dominate the gingival tissues. Neutrophils, a type of white blood cell (leukocyte), represent a key component of the innate defence system that protects periodontal tissue from both gingivitis and periodontitis. Not only are they the first line of cellular defence, but they are among the most abundant leukocytes within the periodontal tissues. During gingivitis a significant increase in the number of neutrophils is seen to correspond to disease severity. In accordance, there was a recent approval by Health Canada for the use of salivary neutrophil activity as a measure of inflammatory load that corresponds with risk for gingivitis and/or periodontal disease.
Investigators propose using a novel strain, Streptococcus salivarius SALI-10, as a targeted microbial intervention to reduce oral inflammation. S. salivarius SALI-10 is hypothesized to:
A twice-daily lozenge, one in the morning and one in the evening, after brushing and tongue scraping, will be issued containing S. salivarius SALI-10 (3 billion CFU/lozenge) for 4 weeks.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 507 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Ostia Sciences is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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For sexually active volunteers of , one of the following methods must be used to prevent pregnancy during the study by participants.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm will receive lozenges without the active ingredient
Other: Placebo
This arm will receive lozenges containing the active ingredient (3B CFUs of SALI-10)
Dietary Supplement: 3B SALI-10 Lozenge
A lozenge containing 3B CFUs of the probiotic . S. salivarius SALI-10
It is a placebo lozenge with no active ingredient.
Reduction of gingival inflammation between the probiotic and placebo groups determined by bleeding on probing (BOP)
This study will assess the efficacy of SALI-10 in reducing gingival inflammation following administration of probiotic lozenges containing SALI-10 compared with a placebo lozenge. This will be measured using bleeding on probing, defined as bleeding observed in more than 10% of probing sites. Statistical analysis (e.g. Students t-test) will be conducted to compare the participants' data from baseline (day -21), start of intervention (day 0), completion of intervention (day 30), and the washout period (day 60), with significance at p≤ 0.05 across both the probiotic and placebo groups.
Time frame: 81 days
Reduction of gingival inflammation between the probiotic and placebo groups determined by oral inflammatory load
This study will assess the efficacy of SALI-10 in reducing gingival inflammation following administration of probiotic lozenges containing SALI-10 compared to a placebo lozenge. This will be measured by oral inflammatory load, as defined by oral neutrophil (oPMN) counts. Statistical analysis (e.g. Students t-test) will be conducted to compare the participants' data from baseline (day -21), start of intervention (day 0), completion of intervention (day 30), and the washout period (day 60), with significance at p≤ 0.05 across both the probiotic and placebo groups.
Time frame: 81 days
Number of patients with treatment-related adverse events of twice-daily SALI-10 lozenge using an end of study questionnaire
In this study, investigators will evaluate the safety and tolerability of a twice-daily SALI-10 lozenge use, one in the morning and one in the evening, after brushing and tongue scraping, over 4 weeks. To determine this, participants will be given an end-of-study questionnaire including parameters such as: How easy was it to use the lozenge as instructed? How was the taste of the lozenge (determined using a scale)? Did you experience any side effects (with listed side effects)? Statistical analysis (e.g. Students t-test) will be conducted to compare the participants' data with significance at p≤ 0.05 between the probiotic and placebo groups.
Time frame: 81 days
Determine the probiotics impacts on halitosis through patient-reported outcomes using the HALT questionnaire
To assess the effect of the probiotic on halitosis, investigators will assess patient-reported outcomes (HALT questionnaire, 20-item, 6-point Likert scale) for both active and placebo lozenge participants. Statistical analysis (e.g. Students t-test) will be conducted to compare the participants' data from baseline (day -21), start of intervention (day 0), completion of intervention (day 30), and the washout period (day 60), with significance at p≤ 0.05 across both the probiotic and placebo groups.
Time frame: 81 days
Determine the probiotics' impacts on halitosis through volatile sulfur compounds (VSC) in pbb
To assess the effect of the probiotic on halitosis, investigators will measure VSC using a Halimeter (in pbb) in both active and placebo lozenge participants. Statistical analysis (e.g. Students t-test) will be conducted to compare the participants' data from baseline (day -21), start of intervention (day 0), completion of intervention (day 30), and the washout period (day 60), with significance at p≤ 0.05 across both the probiotic and placebo groups.
Time frame: 81 days
Plan to share: Undecided — No decisions have yet been made on this matter.
Started May 2026 (actual). Primary completion is estimated for Jan 2027, 8 months after the start.
Of 53 industry-sponsored interventional studies with no phase under Gingivitis, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 5. This study's planned 8 months is above that.
Counting every sponsor, half of 257 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
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