Probiotic Lozenges for Oral Hygiene
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new probiotic lozenge made from S. salivarius SALI-10, which may improve oral health by balancing mouth bacteria. The focus is on gingivitis, a common gum disease caused by plaque buildup, leading to inflammation and other oral health issues. Participants will use the lozenge nightly for a week to determine if it reduces harmful bacteria and inflammation. Individuals with healthy gums, who do not smoke, and are fluent in English may be suitable for this trial. As an Early Phase 1 trial, this research aims to understand how this new treatment works in people, offering participants the chance to be among the first to try this innovative approach to improving oral health.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any current medications, especially anti-inflammatory, antibiotics, or antimicrobial drugs, at least 30 days before joining the study.
What prior data suggests that this lozenge is safe for oral use?
Research shows that the probiotic Streptococcus salivarius SALI-10, currently under testing, is generally safe. Studies on similar types of S. salivarius, such as K12, have found good tolerance among people. These studies did not report any major side effects, suggesting the treatment is safe for oral use. S. salivarius strains are also known to combat harmful bacteria, potentially improving oral health. Although this trial remains in the early stages, evidence from related studies supports the safety of SALI-10 for people.12345
Why do researchers think this study treatment might be promising?
Unlike the standard oral hygiene treatments like toothpaste and mouthwash, which primarily focus on mechanical cleaning and chemical disinfection, Salivarius SALI-10 lozenges work by modifying the oral microbiome. These lozenges introduce beneficial bacteria, specifically Streptococcus salivarius, directly into the mouth to help balance the bacterial environment. Researchers are excited because this approach not only targets harmful bacteria but also boosts beneficial ones, potentially reducing inflammation in a natural and gentle way. Plus, with a convenient lozenge form taken before bed, it offers a simple and innovative method to enhance oral health.
What evidence suggests that this probiotic lozenge is effective for gingivitis?
Research shows that Salivarius SALI-10, which participants in this trial will receive, might help combat the bacteria in the mouth that cause gum diseases like gingivitis. It produces substances that can kill harmful bacteria, including those leading to periodontal diseases. Studies have found that similar types of S. salivarius can increase the amount of beneficial bacteria in the mouth. This increase might help restore balance and reduce swelling. Although most current evidence comes from lab studies, Salivarius SALI-10 shows promising potential to improve oral health.46789
Who Is on the Research Team?
Michael Glogauger, MD
Principal Investigator
Ostia Sciences Inc
Are You a Good Fit for This Trial?
This trial is for adults interested in improving oral hygiene. It's exploring if lozenges can be an effective way to deliver S. salivarius SALI-10 probiotics, which might help with conditions like gingivitis by shifting the balance of bacteria in the mouth.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants self-administer one lozenge containing S. salivarius SALI-10 each night for 7 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Salivarius SALI-10
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ostia Sciences
Lead Sponsor