[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ostia Sciences\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100632065","evaluation-of-the-safety-and-efficacy-of-sali-10-probiotic-lozenges-100632065",false,"NCT07508839","Evaluation of the Safety and Efficacy of SALI-10 Probiotic Lozenges","Evaluation of the Safety and Efficacy of SALI-10 Probiotic Lozenges: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n1. Male or female volunteers aged 18-70 years\n2. In good general health, ASA I\n3. Non-smokers\n4. Fluent in English\n5. For sexually active volunteers of childbearing potential, one of the following methods must be used to prevent pregnancy during the study by participants.\n\n   1. Post-menopausal\n   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;\n   3. barrier methods must be in use at least 14 days prior to study drug administration;\n   4. that vasectomy on the male partner must be completed 3 months prior to first study drug administration;\n   5. or in the alternative that a 0 sperm count for the male partner will suffice\n\nExclusion Criteria:\n\n1. Presence of orthodontic bands.\n2. Presence of partial removal dentures.\n3. Dental pain at time of screening.\n4. 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.\n5. Participation in any other clinical study or test panel within one month before entering the study.\n6. Current use of anti-inflammatory, antibiotics, or antimicrobial drugs or within the last 30 days of enrolment.\n7. Those taking anticoagulant medications and have blood and bleeding disorders\n8. Those who have recently experienced (past 30 days) or will be experiencing (next 90 days) dental, oral, or any type of surgery\n9. History of systemic inflammatory or immune conditions or immunocompromised conditions\n10. Pregnant or nursing women or those planning on getting pregnant.\n11. Use of tobacco products.\n12. Long-term antibiotic or anti-inflammatory therapy.\n13. 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)\n14. Medication or Natural Health Products (NHPs) that could affect the gingiva like calcium channel blockers, anti-epileptic therapy etc.\n15. Participants who are experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain.\n16. Presence of active infections\n17. Use of any probiotic\n18. Use of anti-plaque\u002Fanti-gingivitis products\n19. Subjects who must receive dental treatment during the study elates\n20. Concurrent orthodontic treatment\n21. Untreated carious lesions and\u002For inadequate restorations on maxillary posterior teeth\n22. Periodontal disease (periodontal pockets, probing depth (PD) \\\u003C 3.0 mm on at least one tooth\u002Fsite, presence of Clinical Attachment Loss (CAL) = 0 mm, or periodontal disease history)","ALL","18 Years","70 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nRecent 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.\n\nThe 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.\n\nUnderstanding 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.\n\nNeutrophils, 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.\n\nAgainst 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.\n\nIn 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.",[27,28],"Gingivitis","Halitosis",[30,31],"Oral Health","Probiotics","NOT_YET_RECRUITING","2026-03-27",{"date":35,"type":36},"2026-04-02","ACTUAL",{"date":38,"type":21},"2026-04",{"date":40,"type":21},"2027-04",{"name":42,"class":43},"Ostia Sciences","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":44},"100612681","phase-2-efficacy-of-sali-10-oral-probiotics-in-experimental-gingivitis-100612681","NCT07256743","Efficacy of SALI-10 Oral Probiotics in Experimental Gingivitis","A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy SALI-10 Oral Probiotics in Experimental Gingivitis","Inclusion Criteria:\n\n1. Male or female volunteers aged 18-70 years\n2. In good general health, ASA I\n3. No clinical signs of gingival inflammation at \\>90% of sites observed\n4. Absence of Periodontal Pockets, Probing Depth (PD) \\\u003C 3.0 mm on all teeth\u002Fsite\n5. Absence of Clinical Attachment Loss (CAL) = 0 mm\n6. No periodontal disease history\n7. Have at least 20 gradeable teeth\n8. Non-smokers\n9. Fluent in English\n10. 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.\n\nExclusion Criteria:\n\n1. Presence of orthodontic bands.\n2. Presence of partial or full dentures.\n3. Tumour(s) of the soft or the hard tissues of the oral cavity.\n4. Cavitated carious lesions requiring immediate restorative treatment.\n5. History of allergy to a consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study.\n6. Participation in any other clinical study or test panel within one month before entering the study.\n7. Medical condition which requires pre-medication before dental visits\u002Fprocedures\n8. Current use of anti-inflammatory, antibiotics, or antimicrobial drugs or within the last 30 days of enrolment.\n9. History of periodontal disease.\n10. History of systemic inflammatory, immune conditions and immunocompromised conditions\n11. Pregnant or nursing women or those planning to get pregnant\n12. Use of tobacco products.\n13. Long-term antibiotic or anti-inflammatory therapy.\n14. Medication or Natural Health Products (NHPs) that could affect the gingiva like calcium channel blockers, anti-epileptic therapy etc.\n15. 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\n16. Allergy to any of the following ingredients: Streptococcus Salivarius, Sorbitol, Isomalt, Calcium phosphate dibasic, Potato starch, Mint, Glyceryl dibehenate, Stevia, Maltodextrin\n17. Use of other probiotics\n18. Taking anticoagulant medications and those suffering from blood and bleeding disorders\n19. Recently experienced or will be experiencing dental, oral or any type of surgery.\n20. Use of anti-plaque\u002F anti-gingivitis products\n21. Presence of active infections\n22. Participants who are experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain.\n23. Use of any antibiotics.",true,{"count":20,"type":21},[55],"PHASE2","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.\n\nMicrobial 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.\n\nA 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.",[27],[59,30,60],"Probiotic","Lozenge","RECRUITING","2025-11-25",{"date":64,"type":36},"2025-12-01",{"date":66,"type":36},"2025-09-01",{"date":68,"type":21},"2026-06-01",{"name":42,"class":43},""]