The goals of this clinical study are:

1. Survey approximately 600 persons between the ages of 18-80 regarding their medical history & oral hygiene habits, diet & exercise habits, and emotional & physical stressors to understand the barriers this population may face in achieving or maintaining good oral care and whole body health.
2. Compare the survey results with the organic molecule data collected by oral swabs from each subject at three different time points over the course of their 60 day study participation to better understand how behaviors and medical history relate to oral and whole body health.
3. Assess the effectiveness of two marketed oral hygiene study products vs a control on oral microbiome--such as bacteria, fungi, viruses that live naturally in our body-as well as its impact on the oral microbiome of each subject.

The study products used in this study are 1 marketed oral lozenge, 1 marketed water additive.

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.

Inclusion Criteria:

1. Adult (18 to 80 years old), all genders, all incomes, of any race (target of 20% non- Caucasian;
2. Non-smokers or those who have currently stopped for at least 2 years;
3. Can wear full dentures;
4. No oral antibiotic taken in the past 30 days;
5. May have gums that sometimes bleed upon brushing, flossing or eating;
6. Willing to take an investigational dental hygiene product, daily, for 60 days;
7. Must be able to read and understand the consent;
8. Must be willing to answer study questionnaires at the clinical site using a laptop;
9. Must be willing to participate in 3 onsite clinical visits.

Exclusion Criteria:

1. Subject is pregnant or breastfeeding
2. Subject has been on an oral antibiotic within the previous 30 days;
3. Subject participated in a dental plaque/gingivitis/periodontal clinical trial within the previous 30 days;
4. If the subject reports an allergy to any of the ingredients listed in the ingredient safety information provided in the Appendix.

Outcome Assessor blinded until completion of primary data analysis and unblinded for secondary data analysis.