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NCT Number: NCT07771907

New Functional Ingredient for Oral Care

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.

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Key information

Conditions

Oral Health Related Quality of Life (OHRQoL) Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Salivary Gland Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change from Baseline in Gingival Inflammation as Measured by Modified Gingival Index

    Time frame: Baseline (Day 0), Day 7, and Day 14

  2. Change from Baseline in Gingival Inflammation as Measured by Bleeding on Probing

    Time frame: Baseline (Day 0), Day 7, and Day 14

  3. Change from Baseline in Oral Microbiome Composition and Diversity as Assessed by 16S rRNA Sequencing of Saliva and Gingival Crevicular Fluid Samples

    Time frame: Baseline (Day 0), Day 7, and Day 14

  4. Change from Baseline in Self-Reported Dry Mouth Symptoms as Assessed by the Oral Health Impact Profile-14 (OHIP-14)

    Time frame: Baseline (Day 0), Day 7, and Day 14

Secondary outcomes

  1. Change from Baseline in Gum Barrier Integrity and Inflammatory Response as Assessed by Gene Expression Analysis from Oral Mucosal Swabs

    Time frame: Baseline (Day 0) and Day 14

Other outcomes

  1. Change from Baseline in Salivary Composition as Measured by pH

    Time frame: Baseline (Day 0), Day 7, and Day 14

  2. Change from Baseline in Salivary Composition as Measured by Buffering Capacity

    Time frame: Baseline (Day 0), Day 7, and Day 14

  3. Change from Baseline in Salivary Composition as Measured by Flow Rate

    Time frame: Baseline (Day 0), Day 7, and Day 14

  4. Change from Baseline in Gum Redness as Quantified by Image Analysis of Oral Photographs Under Standard Conditions

    Time frame: Baseline (Day 0), Day 7, and Day 14

Study contacts

Contact information is provided by the study sponsor or research team.

Abigail JS Armstrong, PhD

CONTACT

[email protected]

616-787-6054

Eric Pattok, BS

CONTACT

[email protected]

616-787-0476

Sponsors and collaborators

Lead sponsor

Access Business Group

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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