Clinical Research Study to Evaluate the Effect of Colgate Mouthwashes on Oral Microbiome in Oral Tissue Samples
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Microbiome
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •Use of medications that can currently affect salivary flow.
- •Use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, antibiotics, antimicrobial, anti-inflammatory medication or daily analgesics within 30 days prior to the start of the study or scheduled to start such intake during the course of the study.
- •Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine)
- •Pregnant or nursing women.
- •Participation in any other clinical study within 1 week prior to enrollment into this study.
- •Use of any tobacco products.
- •Subjects who must receive dental treatment during the study dates.
- •Presence of an orthodontic appliance that interferes with required clinical assessments.
- •History of allergy to common dentifrice ingredients.
- •Subjects who wear night guard, denture retainers
- •Not willing to abstain from eating crunchy (eg. Granola bars, popcorns, nuts etc) or spicy and hot foods/liquids during the study period;
- •Not willing to abstain from drinking citrus fluids, alcohol, and tea during the study period
- •Non English-speaking subjects
Arms & Interventions
Placebo 1
A mouthwash without cetylpyridinium chloride and pH adjuster 1
Intervention: cetylpyridinium chloride (Other)
Placebo 2
A mouthwash without cetylpyridinium chloride and pH adjuster 2
Intervention: cetylpyridinium chloride (Other)
Cetylpyridinium chloride/pH adjuster 2
A mouthwash contains cetylpyridinium chloride and pH adjuster 2.
Intervention: cetylpyridinium chloride (Other)
Cetylpyridinium chloride/pH adjuster 1
A mouthwash contains cetylpyridinium chloride and pH adjuster 1.
Intervention: cetylpyridinium chloride (Other)
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)
Investigators
Praveen Kumar Gajendrareddy
Professor
University of Illinois at Chicago