New Functional Ingredient for Oral Care

NCT07771907 · tracked via the Priya Life Science USA tracker

Sponsor

Access Business Group

Phase

Not applicable

Started

2026-09

Last updated

2026-08-19

Condition(s) studied

Oral Health Related Quality of Life (OHRQoL)

Investigational drug(s) / intervention(s)

Botanical ABotanical BVehicle (Placebo solution)

Botanical A: The intervention involves the daily use of a mouth rinse twice daily for 14 days. This mouthwash will contain proprietary botanical, "Botanical A"

Botanical B: The intervention involves the daily use of a mouth rinse twice daily for 14 days. This mouthwash will contain proprietary botanical, "Botanical B"

Vehicle (Placebo solution): The intervention involves the daily use of a mouth rinse twice daily for 14 days. This mouthwash will not contain any botanicals - vehicle control

Study 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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Change from Baseline in Gingival Inflammation as Measured by Modified Gingival Index — Baseline (Day 0), Day 7, and Day 14
Change from Baseline in Gingival Inflammation as Measured by Bleeding on Probing — Baseline (Day 0), Day 7, and Day 14
Change from Baseline in Oral Microbiome Composition and Diversity as Assessed by 16S rRNA Sequencing of Saliva and Gingival Crevicular Fluid Samples — Baseline (Day 0), Day 7, and Day 14
Change from Baseline in Self-Reported Dry Mouth Symptoms as Assessed by the Oral Health Impact Profile-14 (OHIP-14) — Baseline (Day 0), Day 7, and Day 14

Trial sites (1)

Facility	City	Region	Status
Advanced Imaging & Measurement Lab Access Business Group	Grand Rapids	Michigan

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07771907 on ClinicalTrials.gov ↗ ← All trials in the USA