Comprehensive Multi-omics Characterization and Implications of Non-Pharmaceutical Dental Hygiene Product in a Randomized Controlled Large Population Study.
Comprehensive Multi-omics Characterization and Implications of Non-Pharmaceutical Dental Hygiene Product in a Randomized Controlled Large Population Study.
NCT ID: NCT07451782 Phase: NA Status: COMPLETED Enrollment: 595 Completion: 2025-07-23
Conditions
Basic Science, Intervention Studies, Biomarker Discovery
Interventions
Oral Lozenges (Tradename pHossident), Water additive (Tradename Protektin)
Summary
The goals of this clinical study are:
- 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.
- 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.
- 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.
Primary Outcome
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.