New Functional Ingredient for Oral Care

NCT07771907 — Not applicable, Not yet recruiting, 100 participants, Access Business Group
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RegistryNCT07771907
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, factorial, masking: triple, treatment
Enrollment100 (Estimated)
SponsorAccess Business Group (Industry)
ConditionsOral Health Related Quality of Life (OHRQoL)
InterventionsBotanical A, Botanical B, Vehicle (Placebo solution) (Dietary supplement)
Datesstart 2026-09-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-03-01 (estimated), first posted 2026-08-19, last updated 2026-08-19
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Oral Health Related Quality of Life (OHRQoL) All trials of Botanical A All trials of Botanical B

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Botanical AExperimentalDietary Supplement: Botanical A
Botanical BExperimentalDietary Supplement: Botanical B
Botanical A + Botanical BExperimentalDietary Supplement: Botanical A; Dietary Supplement: Botanical B
Vehicle ControlPlacebo comparatorDietary Supplement: Vehicle (Placebo solution)
  • 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

+Outcome measures

Primary outcomes

  • 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]

Secondary outcomes

  • Change from Baseline in Gum Barrier Integrity and Inflammatory Response as Assessed by Gene Expression Analysis from Oral Mucosal Swabs [Baseline (Day 0) and Day 14]

Other outcomes

  • Change from Baseline in Salivary Composition as Measured by pH [Baseline (Day 0), Day 7, and Day 14]
  • Change from Baseline in Salivary Composition as Measured by Buffering Capacity [Baseline (Day 0), Day 7, and Day 14]
  • Change from Baseline in Salivary Composition as Measured by Flow Rate [Baseline (Day 0), Day 7, and Day 14]
  • Change from Baseline in Gum Redness as Quantified by Image Analysis of Oral Photographs Under Standard Conditions [Baseline (Day 0), Day 7, and Day 14]

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
Advanced Imaging & Measurement Lab Access Business GroupGrand Rapids, MichiganUnited States

+Investigators