An interventional study of cetylpyridinium chloride in Wound Heal and Oral Microbiome, sponsored by University of Illinois at Chicago. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-22.
Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Basic science
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 859 are open to participants now.
This study's enrollment of 34 is below the median of 52 across 3,240 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
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Exclusion Criteria
A mouthwash contains cetylpyridinium chloride and pH adjuster 1.
Other: cetylpyridinium chloride
A mouthwash without cetylpyridinium chloride and pH adjuster 1
Other: cetylpyridinium chloride
A mouthwash contains cetylpyridinium chloride and pH adjuster 2.
Other: cetylpyridinium chloride
A mouthwash without cetylpyridinium chloride and pH adjuster 2
Other: cetylpyridinium chloride
The mouthwash is used to see the effects on wound healing and the oral microbiome.
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.
Time frame: 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.
Time frame: 5 Days
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.
Time frame: 3 Days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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University of Illinois at Chicago