Oral Health Related Quality of Life (OHRQoL)
Conditions
Keywords
Gingivitis, Xerostomia, Oral Microbiome, Oral Health-Related Quality of Life
Brief 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.
Interventions
DIETARY_SUPPLEMENTBotanical A
The intervention involves the daily use of a mouth rinse twice daily for 14 days. This mouthwash will contain proprietary botanical, "Botanical A"
DIETARY_SUPPLEMENTBotanical B
The intervention involves the daily use of a mouth rinse twice daily for 14 days. This mouthwash will contain proprietary botanical, "Botanical B"
DIETARY_SUPPLEMENTVehicle (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
Sponsors
Access Business Group
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
CONTACTAbigail JS Armstrong, PhD
CONTACTEric Pattok, BS
PRINCIPAL_INVESTIGATORAbigail JS Armstrong, PhD
Access Business Group
Outcome results
None listed