Clinical Research Study to Evaluate the Effect of Colgate Mouthwashes on Oral Microbiome in Oral Tissue Samples
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Wound Heal
- Sponsor
- University of Illinois at Chicago
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Microbiome
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this clinical research study is to investigate if mouthwashes to be tested can affect oral mucosal wound healing and change the oral microbiome (bacteria colonization) or expression of selected biomarkers.
Investigators
Praveen Kumar Gajendrareddy
Professor
University of Illinois at Chicago
Eligibility Criteria
Inclusion Criteria
- •Male or female volunteers 18-45 years of age.
- •Good general health.
- •Must sign informed consent form.
- •Minimum of 17 natural uncrowned teeth (excluding third molars) must be present.
- •Exclusion Criteria
- •Oral pathology, chronic disease, or history of allergy to testing product.
- •Medical condition which requires pre-medication prior to dental visits/procedures
- •Moderate or advanced periodontal disease (gum disease) or periodontal probing depths greater than 4 mm.
- •Five (5) or more decayed untreated dental sites at screening (cavities).
- •Impaired salivary function.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Microbiome
Time Frame: 5 Days
Swabs will be collected from the hard palate on both the wounded and unwounded sides before and after injury and the mouthwash treatment at days 1, 3, 5, and 7. 16S rRNA sequencing will be performed to determine the bacteria microbiome. Correlations and relative abundance of bacteria will be compared at phylum and genus levels using bioinformatics tools between a mouthwash treated group and its placebo at different time points.
Wound healing
Time Frame: 7 Days
Images of the oral wounds will be taken before and after using the mouthwash treatment on days 1, 3, 5, and 7. The images will be taken on a digital camera. The wound sizes will be measured in mm2 using ImageJ software. The wound size will be measured at each time point and will be compared between a tested mouthwash and its placebo.
Secondary Outcomes
- Biomarker expression(3 Days)