GingivitisNCT07508839
Evaluation of the Safety and Efficacy of SALI-10 Probiotic Lozenges
A study testing 3B SALI-10 Lozenge in people with Gingivitis and Halitosis, run by Ostia Sciences at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gingivitis, Halitosis
- What is being tested?
- 3B SALI-10 Lozenge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 4 May 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female volunteers aged 18-70 years
- In good general health, ASA I
- Non-smokers
- Fluent in English
- For sexually active volunteers of childbearing potential, one of the following methods must be used to prevent pregnancy during the study by participants.
- Post-menopausal
Show all 10Show fewer
- 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;
- barrier methods must be in use at least 14 days prior to study drug administration;
- that vasectomy on the male partner must be completed 3 months prior to first study drug administration;
- or in the alternative that a 0 sperm count for the male partner will suffice
Who cannot join
- Presence of orthodontic bands.
- Presence of partial removal dentures.
- Dental pain at time of screening.
- 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.
- Participation in any other clinical study or test panel within one month before entering the study.
- Current use of anti-inflammatory, antibiotics, or antimicrobial drugs or within the last 30 days of enrolment.
Show all 22Show fewer
- Those taking anticoagulant medications and have blood and bleeding disorders
- Those who have recently experienced (past 30 days) or will be experiencing (next 90 days) dental, oral, or any type of surgery
- History of systemic inflammatory or immune conditions or immunocompromised conditions
- Pregnant or nursing women or those planning on getting pregnant.
- Use of tobacco products.
- Long-term antibiotic or anti-inflammatory therapy.
- 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)
- Medication or Natural Health Products (NHPs) that could affect the gingiva like calcium channel blockers, anti-epileptic therapy etc.
- Participants who are experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain.
- Presence of active infections
- Use of any probiotic
- Use of anti-plaque/anti-gingivitis products
- Subjects who must receive dental treatment during the study elates
- Concurrent orthodontic treatment
- Untreated carious lesions and/or inadequate restorations on maxillary posterior teeth
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
OMGPerio
Hamilton, Ontario, L8N 1K4
Dr. Alon Borenstein, MDM, MSc Periodontology, (905) 923-5185, reception@omgperio.ca
Dr. Alon Borenstein, MDM, MSc Periodontology
About this study
Official title: Evaluation of the Safety and Efficacy of SALI-10 Probiotic Lozenges: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
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.
Read more
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.
Read the detailed description
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:
- Reduce inflammation by driving M2 Resolution Phenotype.
- Inhibit the growth of periopathogens such as Porphyromonas, Tannerella and Prevotella through competition and production of Salivaricin 10.
- Reduce halitosis by inhibiting periopathogens that produce volatile sulfur compounds.
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.
- Conditions
- Gingivitis, Halitosis
- Being tested
- 3B SALI-10 Lozenge, Placebo
- Keywords
- Oral Health, Probiotics
- Medical subject headings
- Gingivitis, Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3B SALI-10 LozengeDietary supplement
A lozenge containing 3B CFUs of the probiotic . S. salivarius SALI-10
PlaceboOther
It is a placebo lozenge with no active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | This arm will receive lozenges without the active ingredient Receives: Other: Placebo |
| SALI-10 | Active comparator | This arm will receive lozenges containing the active ingredient (3B CFUs of SALI-10) Receives: Dietary Supplement: 3B SALI-10 Lozenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 81 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: 81 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start4 May 2026
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized, double blind, placebo-controlled clinical trial enrolling 60 participants with gingivitis (BOP above 10%). Participants will be randomly assigned in a 1:1 allocation ratio to receive either SALI-10 probiotic lozenges or placebo lozenges. Randomization will be performed by an independent third party (PMK Federal Regulatory Consultants Ltd.) using a computer-generated randomized sequence. The participants, investigators, and dental clinicians/outcome assessors are all blinded to group allocation. The probiotic and placebo lozenges will be identical in appearance, taste, and packaging to maintain blinding. The randomized code will be held by PMK Federal Regulatory Consultants Ltd. and will not be released until completion of data analysis, unless unblinding is required for safety reasons. Participants will self-administer a twice-daily lozenge, one in the morning and one in the evening, after brushing and tongue scraping.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostia Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Alon Borenstein, MDM, M.Sc Periodontology, Principal investigator, OMGPerio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07508839
- Sponsor's protocol ID
- OstiaOralHealth
- Status last verified
- Aug 2026
- First submitted
- 16 Dec 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No decisions have yet been made on this matter.
Publications
Yin L, Li X, Hou J. Macrophages in periodontitis: A dynamic shift between tissue destruction and repair. Jpn Dent Sci Rev. 2022 Nov;58:336-347. doi: 10.1016/j.jdsr.2022.10.002. Epub 2022 Oct 28.
PubMed 36340583Tarasenko VD, Kozin IaB. [Work standards for the medical personnel of radiodiagnostic laboratories]. Med Radiol (Mosk). 1975 Feb;20(2):43-7. No abstract available. Russian.
PubMed 1134231LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
PubMed 14121956Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
PubMed 5237684Li X, Fields FR, Ho M, Marshall-Hudson A, Gross R, Casser ME, Naito M. Safety assessment of Streptococcus salivarius DB-B5 as a probiotic candidate for oral health. Food Chem Toxicol. 2021 Jul;153:112277. doi: 10.1016/j.fct.2021.112277. Epub 2021 May 15.
PubMed 34004226Lee YH, Shin SI, Hong JY. Investigation of volatile sulfur compound level and halitosis in patients with gingivitis and periodontitis. Sci Rep. 2023 Aug 14;13(1):13175. doi: 10.1038/s41598-023-40391-3.
PubMed 37580412Landzberg M, Doering H, Aboodi GM, Tenenbaum HC, Glogauer M. Quantifying oral inflammatory load: oral neutrophil counts in periodontal health and disease. J Periodontal Res. 2015 Jun;50(3):330-6. doi: 10.1111/jre.12211. Epub 2014 Jul 14.
PubMed 25040400Kuninaka Y, Ishida Y, Ishigami A, Nosaka M, Matsuki J, Yasuda H, Kofuna A, Kimura A, Furukawa F, Kondo T. Macrophage polarity and wound age determination. Sci Rep. 2022 Nov 25;12(1):20327. doi: 10.1038/s41598-022-24577-9.
PubMed 36434083Kerns KA, Bamashmous S, Hendrickson EL, Kotsakis GA, Leroux BG, Daubert DD, Roberts FA, Chen D, Trivedi HM, Darveau RP, McLean JS. Localized microbially induced inflammation influences distant healthy tissues in the human oral cavity. Proc Natl Acad Sci U S A. 2023 Oct 10;120(41):e2306020120. doi: 10.1073/pnas.2306020120. Epub 2023 Oct 2.
PubMed 37782795Hirschfeld J. Neutrophil Subsets in Periodontal Health and Disease: A Mini Review. Front Immunol. 2020 Jan 8;10:3001. doi: 10.3389/fimmu.2019.03001. eCollection 2019.
PubMed 31998301He L, Yang H, Chen Z, Ouyang X. The Effect of Streptococcus salivarius K12 on Halitosis: a Double-Blind, Randomized, Placebo-Controlled Trial. Probiotics Antimicrob Proteins. 2020 Dec;12(4):1321-1329. doi: 10.1007/s12602-020-09646-7.
PubMed 32227309Briceag R, Caraiane A, Raftu G, Bratu ML, Buzatu R, Dehelean L, Bondrescu M, Bratosin F, Bumbu BA. Validation of the Romanian Version of the Halitosis Associated Life-Quality Test (HALT) in a Cross-Sectional Study among Young Adults. Healthcare (Basel). 2023 Sep 30;11(19):2660. doi: 10.3390/healthcare11192660.
PubMed 37830697Berezow AB, Darveau RP. Microbial shift and periodontitis. Periodontol 2000. 2011 Feb;55(1):36-47. doi: 10.1111/j.1600-0757.2010.00350.x. No abstract available.
PubMed 21134227Barbour A, Wescombe P, Smith L. Evolution of Lantibiotic Salivaricins: New Weapons to Fight Infectious Diseases. Trends Microbiol. 2020 Jul;28(7):578-593. doi: 10.1016/j.tim.2020.03.001. Epub 2020 Apr 6.
PubMed 32544444Barbour A, Smith L, Oveisi M, Williams M, Huang RC, Marks C, Fine N, Sun C, Younesi F, Zargaran S, Orugunty R, Horvath TD, Haidacher SJ, Haag AM, Sabharwal A, Hinz B, Glogauer M. Discovery of phosphorylated lantibiotics with proimmune activity that regulate the oral microbiome. Proc Natl Acad Sci U S A. 2023 May 30;120(22):e2219392120. doi: 10.1073/pnas.2219392120. Epub 2023 May 22.
PubMed 37216534
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of SALI-10 Probiotic Lozenges: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07508839
- Acronym / sponsor ID
- OstiaOralHealth
- Conditions
- Gingivitis, Halitosis
- Keywords
- Oral Health, Probiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ostia SciencesIndustry (pharma, biotech, devices)
- Study start
- 4 May 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Reduce inflammation by driving M2 Resolution Phenotype.
- Inhibit the growth of periopathogens such as Porphyromonas, Tannerella and Prevotella through competition and production of Salivaricin 10.
- Reduce halitosis by inhibiting periopathogens that produce volatile sulfur compounds.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a randomized, double blind, placebo-controlled clinical trial enrolling 60 participants with gingivitis (BOP above 10%). Participants will be randomly assigned in a 1:1 allocation ratio to receive either SALI-10 probiotic lozenges or placebo lozenges. Randomization will be performed by an independent third party (PMK Federal Regulatory Consultants Ltd.) using a computer-generated randomized sequence. The participants, investigators, and dental clinicians/outcome assessors are all blinded to group allocation. The probiotic and placebo lozenges will be identical in appearance, taste, and packaging to maintain blinding. The randomized code will be held by PMK Federal Regulatory Consultants Ltd. and will not be released until completion of data analysis, unless unblinding is required for safety reasons. Participants will self-administer a twice-daily lozenge, one in the morning and one in the evening, after brushing and tongue scraping.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboThis arm will receive lozenges without the active ingredient |
| SALI-10 | Active comparator | Dietary Supplement: 3B SALI-10 LozengeThis arm will receive lozenges containing the active ingredient (3B CFUs of SALI-10) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female volunteers aged 18-70 years
- In good general health, ASA I
- Non-smokers
- Fluent in English
- For sexually active volunteers of childbearing potential, one of the following methods must be used to prevent pregnancy during the study by participants.
Key exclusion criteria (22 listed)
- Presence of orthodontic bands.
- Presence of partial removal dentures.
- Dental pain at time of screening.
- 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.
- Participation in any other clinical study or test panel within one month before entering the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3B SALI-10 LozengeA lozenge containing 3B CFUs of the probiotic . S. salivarius SALI-10 | Dietary supplement | SALI-10 |
| PlaceboIt is a placebo lozenge with no active ingredient. | Other | Placebo |
Primary outcome
Reduction of gingival inflammation between the probiotic and placebo groups determined by bleeding on probing (BOP)
Time frame: 81 days
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.
Reduction of gingival inflammation between the probiotic and placebo groups determined by oral inflammatory load
Time frame: 81 days
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.
Number of patients with treatment-related adverse events of twice-daily SALI-10 lozenge using an end of study questionnaire
Time frame: 81 days
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.
2 secondary outcomes
Determine the probiotics impacts on halitosis through patient-reported outcomes using the HALT questionnaire
Time frame: 81 days
Determine the probiotics' impacts on halitosis through volatile sulfur compounds (VSC) in pbb
Time frame: 81 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 36340583Yin L, Li X, Hou J. Macrophages in periodontitis: A dynamic shift between tissue destruction and repair. Jpn Dent Sci Rev. 2022 Nov;58:336-347. doi: 10.1016/j.jdsr.2022.10.002. Epub 2022 Oct 28.
- Background: PubMed 1134231Tarasenko VD, Kozin IaB. [Work standards for the medical personnel of radiodiagnostic laboratories]. Med Radiol (Mosk). 1975 Feb;20(2):43-7. No abstract available. Russian.
- Background: PubMed 14121956LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
- Background: PubMed 5237684Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
- Background: PubMed 34004226Li X, Fields FR, Ho M, Marshall-Hudson A, Gross R, Casser ME, Naito M. Safety assessment of Streptococcus salivarius DB-B5 as a probiotic candidate for oral health. Food Chem Toxicol. 2021 Jul;153:112277. doi: 10.1016/j.fct.2021.112277. Epub 2021 May 15.
- Background: PubMed 37580412Lee YH, Shin SI, Hong JY. Investigation of volatile sulfur compound level and halitosis in patients with gingivitis and periodontitis. Sci Rep. 2023 Aug 14;13(1):13175. doi: 10.1038/s41598-023-40391-3.
- Background: PubMed 25040400Landzberg M, Doering H, Aboodi GM, Tenenbaum HC, Glogauer M. Quantifying oral inflammatory load: oral neutrophil counts in periodontal health and disease. J Periodontal Res. 2015 Jun;50(3):330-6. doi: 10.1111/jre.12211. Epub 2014 Jul 14.
- Background: PubMed 36434083Kuninaka Y, Ishida Y, Ishigami A, Nosaka M, Matsuki J, Yasuda H, Kofuna A, Kimura A, Furukawa F, Kondo T. Macrophage polarity and wound age determination. Sci Rep. 2022 Nov 25;12(1):20327. doi: 10.1038/s41598-022-24577-9.
- Background: PubMed 37782795Kerns KA, Bamashmous S, Hendrickson EL, Kotsakis GA, Leroux BG, Daubert DD, Roberts FA, Chen D, Trivedi HM, Darveau RP, McLean JS. Localized microbially induced inflammation influences distant healthy tissues in the human oral cavity. Proc Natl Acad Sci U S A. 2023 Oct 10;120(41):e2306020120. doi: 10.1073/pnas.2306020120. Epub 2023 Oct 2.
- Background: PubMed 31998301Hirschfeld J. Neutrophil Subsets in Periodontal Health and Disease: A Mini Review. Front Immunol. 2020 Jan 8;10:3001. doi: 10.3389/fimmu.2019.03001. eCollection 2019.
- Background: PubMed 32227309He L, Yang H, Chen Z, Ouyang X. The Effect of Streptococcus salivarius K12 on Halitosis: a Double-Blind, Randomized, Placebo-Controlled Trial. Probiotics Antimicrob Proteins. 2020 Dec;12(4):1321-1329. doi: 10.1007/s12602-020-09646-7.
- Background: PubMed 37830697Briceag R, Caraiane A, Raftu G, Bratu ML, Buzatu R, Dehelean L, Bondrescu M, Bratosin F, Bumbu BA. Validation of the Romanian Version of the Halitosis Associated Life-Quality Test (HALT) in a Cross-Sectional Study among Young Adults. Healthcare (Basel). 2023 Sep 30;11(19):2660. doi: 10.3390/healthcare11192660.
- Individual participant dataSharing planned: Undecided. No decisions have yet been made on this matter.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Alon Borenstein, MDM, M.Sc Periodontology principal investigator
OMGPerio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3B SALI-10 Lozenge in people with Gingivitis and Halitosis, run by Ostia Sciences at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Kwiecinski, P.Eng, M.Sc Physics (1-613-513-4413, Mark@PMKengineering.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of gingival inflammation between the probiotic and placebo groups determined by bleeding on probing (BOP) (time frame: 81 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07508839, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.