New Functional Ingredient for Oral Care

N/ANot Yet RecruitingNCT07771907

Access Business Group100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: Baseline (Day 0) and Day 14

New Functional Ingredient for Oral Care

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts