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

Conditions

• Basic Science
• Biomarker Discovery
• Intervention Studies

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Accepted

Interventions

• Oral Lozenges (Tradename pHossident) — DIETARY_SUPPLEMENT
  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).
• Water additive (Tradename Protektin) — DIETARY_SUPPLEMENT
  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.

Study Details

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.

Key Dates

Start date

Apr 30, 2024

Status verified

Feb 2026

Primary completion

Jul 11, 2024

Completion

Jul 23, 2025

Study Design

Enrollment

595 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Active Comparator: Lozenge Intervention (Tradename pHossident)
  This cohort was randomized and assigned into the pHossident Lozenge cohort. They received 8 lozenges per day for the duration of the study. They completes questionnaires. They were sampled orally at Baseline, Week 4 and Week 8 for multi-omic analyses.
• No Intervention: Control
  Full participation but received no intervention
• Active Comparator: Water Additive Intervention (Tradename Protektin)
  This cohort was randomized and assigned into the Protektin water additive cohort. They received 2 water additive sachets per day for the duration of the study. They completes questionnaires. They were sampled orally at Baseline, Week 4 and Week 8 for multi-omic analyses.

Primary Outcome Measure

Metagenomic changes at 4 and 8 weeks from baseline in pHossident lozenge recipients vs Protektin water additive recipients vs control participants using shotgun sequencing of salivary DNA isolates sequencing depth of 35.4M read pairs per sample. [ Time Frame: Initial visit: baseline measurements to 8 week endpoint measurements ]

Locations (1)

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