NCT07451782

Comprehensive Multi-omics Characterization and Implications of Non-Pharmaceutical Dental Hygiene Product in a Randomized Controlled Large Population Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 595 (actual)
• Sponsor: Delta Dental of Minnesota Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Basic Science
• Intervention Studies
• Biomarker Discovery

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oral Lozenges (Tradename pHossident)	dissolvable mint flavored pHossident lozenges containing ingredients that are all FDA-approved with the GRAS (Generally Recognized As Safe) designation, and have years of safety demonstrated in animals, children, adults and pregnant women. The lozenge is not classified as a drug and is regulated as a nutritional supplement. The lozenge does contain the sugar substitutes called mannitol and sorbitol (sugar alcohols), as well as the natural sweetener, stevia, all of which can irritate the lower gastrointestinal tract at amounts that grossly exceed the levels that are contained in the lozenges (I lozenge contains \<l % of the recommended daily intake).
DIETARY_SUPPLEMENT	Water additive (Tradename Protektin)	Commercially marketed over-the-counter Protektin drinking water additive contains ingredients that are all FDA-approved with the GRAS designation, and have years of safety demonstrated in animals, children, adults and pregnant women. The water additive is not classified as a drug and is regulated as a nutritional supplement. The water additive only contains active ingredients; it does not contain fillers, flavors or sweeteners.

Timeline

• Start date: 2024-04-30
• Primary completion: 2024-07-11
• Completion: 2025-07-23
• First posted: 2026-03-05
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States