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NCT07771907
New Functional Ingredient for Oral Care
Conditions: Oral Health Related Quality of Life (OHRQoL)
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 100
Sponsor: Access Business Group
Location: Advanced Imaging & Measurement Lab Access Business Group Grand Rapids Michigan
Summary
The goal of this clinical trial is to find new ingredients for oral care products that can improve gum health. We want to learn if new botanical blends can help reduce gum inflammation, strengthen the gum's natural barrier, and lessen dry mouth symptoms. This study will also look at how these ingredients affect the helpful bacteria in the mouth (oral microbiome) and overall oral health.
Researchers will compare different botanical blends against a control group that uses a simple mouthwash without the active ingredients to see their effects.
Participants will use a simple mouthwash daily for 14 days. This mouthwash will contain either one of two botanical ingredients, a combination of both, or no active ingredient (a control). During the study participants will complete questionnaires about their quality of life and any dry mouth symptoms at home and provide samples of saliva and fluid from their gums at different times during the study to check for changes in their oral microbiome and inflammation levels.
Eligibility Criteria
Inclusion Criteria:
* Healthy Adults
Exclusion Criteria:
* Women who are pregnant, breastfeeding, or planning to become pregnant during the study period
* Known allergy or hypersensitivity to any of the study materials or ingredients
* Current smokers or individuals who have used tobacco products (including smokeless tobacco) within the last 6 months
* Antibiotic use within 3 months of study start
* Current use of key drugs - Systemic Anti-inflammatory Drugs, Immunosuppressants, and Drugs known to cause Xerostomia
* Current use of anti-gingivitis products Presence of extensive fixed or removable prosthodontic appliances or less than 50% of natural teeth
* History of diagnosed periodontal disease requiring treatment, including active periodontal disease, extensive untreated caries, or significant oral lesions
* History of chronic systemic diseases including: cardiovascular disease, uncontrolled diabetes, autoimmune diseases, HIV, and Hepatitis B or C
* Concurrent participation in another clinical study.
Source: ClinicalTrials.gov (NCT07771907). StuddyBuddy aggregates publicly available trial information.