Health TrialsbyHealthPanel

New Functional Ingredient for Oral Care

ConditionOral Health Related Quality of Life (OHRQoL)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAccess Business Group

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy Adults

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Botanical AExperimental treatment 1 intervention
Group B: Botanical BExperimental treatment 1 intervention
Group C: Botanical A + Botanical BExperimental treatment 2 interventions
Group D: Vehicle ControlPlacebo comparator 1 intervention

Trial outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Access Business Group

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: