NCT07256743 Efficacy of SALI-10 Oral Probiotics in Experimental Gingivitis

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 60 participants in total. It began in 2025-09-01 with a primary completion date of 2025-12-31.

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.

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.

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