Comprehensive Multi-omics Characterization and Implications of Non-Pharmaceutical Dental Hygiene Product in a Randomized Controlled Large Population Study.
Completed · Not applicable
Conditions studied: Basic Science, Intervention Studies, Biomarker Discovery
In brief
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 facts
- Study ID
- NCT07451782
- Run by
- Delta Dental of Minnesota Foundation
- People needed
- 595
- Starts
- 2024-04-30
- Expected to finish
- 2025-07-23
- Last updated by the study team
- 2026-03-05
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adult (18 to 80 years old), all genders, all incomes, of any race (target of 20% non- Caucasian;
- Non-smokers or those who have currently stopped for at least 2 years;
- Can wear full dentures;
- No oral antibiotic taken in the past 30 days;
- May have gums that sometimes bleed upon brushing, flossing or eating;
- Willing to take an investigational dental hygiene product, daily, for 60 days;
- Must be able to read and understand the consent;
- Must be willing to answer study questionnaires at the clinical site using a laptop;
- Must be willing to participate in 3 onsite clinical visits.
You may not qualify if…
- Subject is pregnant or breastfeeding
- Subject has been on an oral antibiotic within the previous 30 days;
- Subject participated in a dental plaque/gingivitis/periodontal clinical trial within the previous 30 days;
- If the subject reports an allergy to any of the ingredients listed in the ingredient safety information provided in the Appendix.
Where it is running
- Comprehensive Research Group — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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