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Completed

NCT Number: NCT05270382

Effect of Mouthwashes on Oral Wound Healing and Microbiome

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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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center, College of Dentistry, University of Illinois Chicago

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cetylpyridinium chloride

Other

The mouthwash is used to see the effects on wound healing and the oral microbiome.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Biomarker expression

    Time frame: 3 Days

    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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

Clinical Research Study to Evaluate the Effect of Colgate Mouthwashes on Oral Microbiome in Oral Tissue Samples

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2022
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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