Determining the Viability a Lozenge Dosage for Probiotics

Launched by OSTIA SCIENCES · Feb 5, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether a lozenge can be an effective way to deliver a specific type of probiotic, called S. salivarius SALI-10, to help improve oral health, particularly for people with gingivitis. Gingivitis is a common gum disease that affects many adults and can lead to more serious dental issues if not treated. The researchers want to find out if using a lozenge can help deliver these probiotics effectively to benefit oral health.

To participate in this study, volunteers must be between 18 and 70 years old, generally healthy, and fluent in English. However, there are some restrictions; for example, individuals with certain dental appliances, those who smoke, or people with a history of gum disease or allergies to dental products are not eligible. Participants will not need to make any significant changes to their everyday lives, and the study is in the early stages, so they will be helping to pave the way for future research in oral health.

Gender

ALL

Eligibility criteria

• 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.