Efficacy of SALI-10 Oral Probiotics in Experimental Gingivitis

NCT07256743 | Recruiting Phase 2

• 1 other identifier: OstiaGingivitis
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Gingivitis is among the most prevalent oral diseases worldwide, affecting an estimated 50-90% of adults. It is a reversible condition primarily caused by microbial plaque accumulation on teeth and gingival surfaces, which triggers inflammation. Standard care emphasizes plaque reduction through oral hygiene, and research shows gingivitis can be reversed once hygiene resumes. The classic experimental gingivitis (EG) model developed in 1965 by Löe and Silness demonstrated the direct link between plaque buildup and gingival inflammation, further confirming that gingival health can be restored after resuming proper care. Microbial ecology shifts are central to gingivitis pathogenesis. In health, the oral microbiome is dominated by gram-positive Streptococcus species. With plaque accumulation, microbial communities transition to gram-negative periopathogens such as Porphyromonas, Tannerella, Treponema, and Prevotella. This dysbiosis provokes heightened inflammation, tissue damage, and, in susceptible individuals, progression to periodontitis. Individual variability in the inflammatory response has been associated with differences in the presence and activity of beneficial streptococci. Certain strains of Streptococcus salivarius produce lantibiotics called salivaricins-polycyclic antimicrobial peptides containing lanthionine residues. Salivaricins inhibit oral pathogens and have been investigated for their antimicrobial and probiotic properties, particularly in the context of rising antibiotic resistance. Probiotic S. salivarius strains isolated from healthy individuals have demonstrated safety and antimicrobial potential in previous studies, supporting their use in preventing oral and respiratory infections. A strain of S. salivarius designated SALI-10 produces a lantibiotic, Salivaricin 10, and is being evaluated as a candidate for gingivitis prevention. This strain is hypothesized to (1) help stabilize populations of beneficial streptococci during plaque accumulation, (2) competitively inhibit periopathogens such as Porphyromonas and Prevotella, and (3) suppress the dysbiotic shift toward gram-negative dominance. By contributing to microbial balance and reducing inflammatory triggers, SALI-10 may support resilient host-microbe interactions associated with gingival health. This approach may offer a dual antimicrobial and microbiome-stabilizing strategy with relevance to gingivitis management and longer-term periodontal health.

Conditions

Gingivitis

Keywords

Probiotic; Oral Health; Lozenge

Outcome Measures

Primary Outcomes (1)

• Mean change in percentage of sites with bleeding on probing (BOP)

  Bleeding on probing (BOP) will be assessed at six sites per tooth using a UNC-15 periodontal probe. The proportion of bleeding sites (% of total sites) will be calculated for each participant. Group mean ± SD change from baseline will be reported. Scale: 0-100 %; lower values = less gingival inflammation.

  Baseline; Weeks 1 and 2 (pre-induction); Weeks 3 - 5 (induction phase - no-brushing); Weeks 6 and 7 (resolution phase).

Secondary Outcomes (6)

• Change in oral neutrophil (oPMN) count per 10 mL unstimulated saliva

  Baseline; Weeks 1 and 2 (pre-induction); Weeks 3 - 5 (induction phase - no-brushing); Weeks 6 and 7 (resolution phase).

• Change in concentration of cytokines (IL-1β, IL-6, MMP-8) in gingival crevicular fluid (pg/mL)

  Baseline; Weeks 1 and 2 (pre-induction); Weeks 3 - 5 (induction phase - no-brushing); Weeks 6 and 7 (resolution phase).

• Change in relative abundance of periodontal and commensal bacteria measured by quantitative PCR and shotgun metagenomics

  Baseline; Weeks 1 and 2 (pre-induction); Weeks 3 - 5 (induction phase - no-brushing); Weeks 6 and 7 (resolution phase).

• Change in concentration of volatile sulfur compounds (VSCs) in exhaled air measured by Halimeter (ppb)

  Baseline; Weeks 1 and 2 (pre-induction); Weeks 3 - 5 (induction phase - no-brushing); Weeks 6 and 7 (resolution phase).

• Change in mean Gingival Index (GI) score

  Baseline; Weeks 1 and 2 (pre-induction); Weeks 3 - 5 (induction phase - no-brushing); Weeks 6 and 7 (resolution phase).

Study Arms (2)

Placebo

NO INTERVENTION

Placebo lozenges used

SALI-10

ACTIVE COMPARATOR

Lozenges containing 6B CFUs of

Dietary Supplement: 6B SALI-10

Interventions

6B SALI-10 DIETARY_SUPPLEMENT

Lozenges containing 6B CFUs of probiotic S. salivarius SALI-10

SALI-10

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Absence of Periodontal Pockets, Probing Depth (PD) \< 3.0 mm on all teeth/site
• Absence of Clinical Attachment Loss (CAL) = 0 mm
• No periodontal disease history
• Have at least 20 gradeable teeth
• Non-smokers
• Fluent in English
• 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.

You may not qualify if:

• Presence of orthodontic bands.
• Presence of partial or full dentures.
• Tumour(s) of the soft or the hard tissues of the oral cavity.
• Cavitated carious lesions requiring immediate restorative treatment.
• History of allergy to a consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study.
• Participation in any other clinical study or test panel within one month before entering the study.
• Medical condition which requires pre-medication before dental visits/procedures
• Current use of anti-inflammatory, antibiotics, or antimicrobial drugs or within the last 30 days of enrolment.
• History of periodontal disease.
• History of systemic inflammatory, immune conditions and immunocompromised conditions
• Pregnant or nursing women or those planning to get pregnant
• Use of tobacco products.
• Long-term antibiotic or anti-inflammatory therapy.
• Medication or Natural Health Products (NHPs) that could affect the gingiva like calcium channel blockers, anti-epileptic therapy etc.
• 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

Sponsors & Collaborators

• Ostia Sciences: lead
• University of Toronto: collaborator

Study Sites (1)

University of Toronto

Toronto, Ontario, M5G 1G5, Canada

RECRUITING

Related Publications (10)

• Wellappuli NC, Fine N, Lawrence HP, Goldberg M, Tenenbaum HC, Glogauer M. Oral and Blood Neutrophil Activation States during Experimental Gingivitis. JDR Clin Trans Res. 2018 Jan;3(1):65-75. doi: 10.1177/2380084417742120. Epub 2017 Nov 20.

  PMID: 30938653 BACKGROUND

• van der Weijden F, Slot DE. Oral hygiene in the prevention of periodontal diseases: the evidence. Periodontol 2000. 2011 Feb;55(1):104-23. doi: 10.1111/j.1600-0757.2009.00337.x. No abstract available.

  PMID: 21134231 BACKGROUND

• LOE H, THEILADE E, JENSEN SB. EXPERIMENTAL GINGIVITIS IN MAN. J Periodontol (1930). 1965 May-Jun;36:177-87. doi: 10.1902/jop.1965.36.3.177. No abstract available.

  PMID: 14296927 BACKGROUND

• Kerns 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.

  PMID: 37782795 BACKGROUND

• Gunsolley JC. A meta-analysis of six-month studies of antiplaque and antigingivitis agents. J Am Dent Assoc. 2006 Dec;137(12):1649-57. doi: 10.14219/jada.archive.2006.0110.

  PMID: 17138709 BACKGROUND

• Gallagher H, Ramsay SC, Barnes J, Maggs J, Cassidy N, Ketheesan N. Neutrophil labeling with [(99m)Tc]-technetium stannous colloid is complement receptor 3-mediated and increases the neutrophil priming response to lipopolysaccharide. Nucl Med Biol. 2006 Apr;33(3):433-9. doi: 10.1016/j.nucmedbio.2005.12.014. Epub 2006 Mar 9.

  PMID: 16631093 BACKGROUND

• Berezow 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.

  PMID: 21134227 BACKGROUND

• Barbour 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.

  PMID: 32544444 BACKGROUND

• Barbour A, Philip K. Variable characteristics of bacteriocin-producing Streptococcus salivarius strains isolated from Malaysian subjects. PLoS One. 2014 Jun 18;9(6):e100541. doi: 10.1371/journal.pone.0100541. eCollection 2014.

  PMID: 24941127 BACKGROUND

• Albandar JM, Rams TE. Global epidemiology of periodontal diseases: an overview. Periodontol 2000. 2002;29:7-10. doi: 10.1034/j.1600-0757.2002.290101.x. No abstract available.

  PMID: 12102700 BACKGROUND

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Dr. Michael Goldberg, MDM

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Kwiecinski, P.Eng, M.Sc Physics

CONTACT

1-613-513-4413; Mark@PMKengineeing.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Once a participant volunteers they begin with a baseline visit. They receive a full oral assessment (probing depth, attachment level, plaque, gingival and bleeding indices) and biospecimen collection (gingival crevicular fluid, plaque, saliva, rinse); and is then assigned a study product: two lozenges (either active or placebo) daily for 14 days, taken after brushing, with instructions to maintain hygiene and return lozenge containers for compliance. Participants attend eight visits. At each, containers are returned, oral exams repeated, biospecimens collected, and questionnaires completed on product use and adverse events. During the induction phase (Day 0-21), subjects refrain from oral hygiene while continuing lozenges twice daily. On Day 21, participants receive prophylaxis and resume oral hygiene while continuing lozenges for two weeks.

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: December 1, 2025
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)