New Functional Ingredient for Oral Care

Conditions

• Oral Health Related Quality of Life (OHRQoL)

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Botanical A — DIETARY_SUPPLEMENT
  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 — DIETARY_SUPPLEMENT
  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) — DIETARY_SUPPLEMENT
  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 Details

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.

Key Dates

First listed

Aug 19, 2026

Start date

Sep 30, 2026

Status verified

Aug 2026

Primary completion

Dec 31, 2026

Completion

Mar 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Experimental: Botanical A
• Experimental: Botanical B
• Experimental: Botanical A + Botanical B
• Placebo Comparator: Vehicle Control

Primary Outcome Measure

Change from Baseline in Gingival Inflammation as Measured by Modified Gingival Index [ Time Frame: Baseline (Day 0), Day 7, and Day 14 ]

Central Contacts

• Abigail JS Armstrong, PhD
  616-787-6054
  [email protected]
• Eric Pattok, BS
  616-787-0476
  [email protected]

Locations (1)

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