Determining the Viability a Lozenge Dosage for Probiotics

Gingivitis is an oral disease condition affecting 50% to 90% of adults globally. 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 shifts from gram-positive health-associated bacteria, to gram-negative disease associated species. This shift triggers inflammatory responses, leading to tissue damage and, in some cases, progression to periodontitis. A promising area of oral health is treating the oral cavity with gram-positive probiotics to improve oral health. One promising candidate is S. salivarius SALI-10. Typically oral probiotics are dosed to the oral cavity using lozenges. This study is a pre-clinical Phase 0 trial to determine is a lozenge is a viable dosage form for the delivery of salivarius SALI-10 oral probiotics.

Inclusion Criteria: 1. Male or female volunteers aged 18-70 years 2. In good general health, ASA I 3. Non-smokers 4. Fluent in English Exclusion Criteria: 1. Presence of orthodontic bands. 2. Presence of partial removal dentures. 3. Dental pain at time of screening. 4. History of allergy to a consumer or personal care products or dentifrice ingredients as determined by the dental profession monitoring the study. 5. Participation in any other clinical study or test panel within one month before entering the study. 6. Current use of anti-inflammatory, antibiotics, or antimicrobial drugs or within the last 30 days of enrolment. 7. History of periodontal disease. 8. History of systemic inflammatory or immune conditions 9. Pregnant or nursing women. 10. Use of tobacco products. 11. Long-term antibiotic or anti-inflammatory therapy. 12. 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; 13. Use of any concomitant medication.