This clinical study had four objectives:
1. To survey 600 volunteers, representative of the Minneapolis / St. Paul population, for their (i) medical history and oral hygiene habits, (ii) diet and exercise habits, and (iii) emotional and physical stressors, to understand what impediments this subpopulation may face in attaining and maintaining good oral and systemic health. The culmination of this work will enable us to evaluate the population, and to better understand and inform us on how to potentially address oral and systemic health for this population, and its extrapolation into the larger Minnesota population.
2. To compare survey results to metabolomic, metagenomic and immune marker data to provide an improved understanding of the relationship between behaviors and medical history with sophisticated biomarkers in a representative Minneapolis / St. Paul population. The culmination of this work will enable us to begin to understand the public health and disease risk profiles for this population and its extrapolation into the larger Minnesota population.
3. To quantitatively assess, using multi-marker (metabolic, microbiome and immune) analyses, the effects of a dental lozenge and a drinking water additive on study participants' biomarkers versus control (no intervention). The culmination of this work will enable us to evaluate two potential options for a daily oral supplement and its modulation of the oral microbiome compared to a control cohort.
4. To assess, using multi-marker (metabolic, microbiome and immune) analyses, the effects between a dental lozenge and a drinking water additive on study participants' biomarkers. The culmination of this work will enable us to determine the best option for a daily oral health supplement and its modulation of the oral microbiome.
The study was designed as an 8-week, double blinded trial comprising 60 days of product usage, targeting a maximum of 600 male and female participants aged 18-80. Recruitment focused on individuals from the Minneapolis-St. Paul metro area who met the specified Inclusion and Exclusion criteria. Upon arrival at the Enrollment visit, subjects underwent informed consent procedures, including engaging in an individual discussion about the study's design and associated risks, and confirmation of study eligibility. Participants not meeting key inclusion and exclusion criteria were excluded at this stage. During this visit, participants completed a questionnaire regarding their medical and dental history. Eligible participants were then randomly assigned to one of three cohorts: a control group without an assigned oral supplement, a dental lozenge, or a drinking water additive . Following randomization, participants were instructed to either take no action, take 2 oral lozenges 4 times a day, or consume a water additive twice daily. A qualified technician collected five oral swabs from each participant using the specified technique. Swabbing involved gentle strokes along the gum line on both the right and left sides (top and bottom), as well as resting the swab along the lower right gum line for 5-30 seconds. Participants returned to the clinical site at week 4 (Visit 2) and week 8 (Visit 3) for further assessments, including questionnaires at week 4 on diet and exercise history, and at week 8 on environmental and lifestyle stressors history. Additional swab collections of five swabs each were also conducted at these visits.
