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| ID | Type | Description | Link |
|---|---|---|---|
| CRO-2018-SAL-08-MW-DC | Other Identifier | Colgate-Palmolive Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetylpyridinium chloride/pH adjuster 1 | Active Comparator | A mouthwash contains cetylpyridinium chloride and pH adjuster 1. |
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| Placebo 1 | Placebo Comparator | A mouthwash without cetylpyridinium chloride and pH adjuster 1 |
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| Cetylpyridinium chloride/pH adjuster 2 | Active Comparator | A mouthwash contains cetylpyridinium chloride and pH adjuster 2. |
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| Placebo 2 | Placebo Comparator | A mouthwash without cetylpyridinium chloride and pH adjuster 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetylpyridinium chloride | Other | The mouthwash is used to see the effects on wound healing and the oral microbiome. |
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| Measure | Description | Time Frame |
|---|---|---|
| Wound healing | 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. | 7 Days |
| Microbiome | 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. | 5 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker expression | Real time polymerase chain reaction will be used to assess the mRNA expression of biomarkers in wound biopsy samples collected at days 1 and 3 post wounding and mouthwash treatment. The biomarkers include collagen I, collagen III, metalloproteinase-2, metalloproteinase-9, Interleukin-1β, Interleukin-6, and vascular endothelial growth factor. The fold changes of biomarker mRNA expression at each time point over the expression in unwounded tissues will be compared between a tested mouthwash and its placebo. |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Praveen Gajendrareddy, BDS, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, College of Dentistry, University of Illinois Chicago | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D002594 | Cetylpyridinium |
| ID | Term |
|---|---|
| D011726 | Pyridinium Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 3 Days |