Effect of Mouthwashes on Oral Wound Healing and Microbiome

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05270382
• Other study ID #: 2018-1417
• Secondary ID: CRO-2018-SAL-08-
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Male or female volunteers 18-45 years of age.

2. Good general health.

3. Must sign informed consent form.

4. Minimum of 17 natural uncrowned teeth (excluding third molars) must be present.

Exclusion Criteria

1. Oral pathology, chronic disease, or history of allergy to testing product.

2. Medical condition which requires pre-medication prior to dental visits/procedures

3. Moderate or advanced periodontal disease (gum disease) or periodontal probing depths greater than 4 mm.

4. Five (5) or more decayed untreated dental sites at screening (cavities).

5. Impaired salivary function.

6. Use of medications that can currently affect salivary flow.

7. 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.

8. Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine)

9. Pregnant or nursing women.

10. Participation in any other clinical study within 1 week prior to enrollment into this study.

11. Use of any tobacco products.

12. Subjects who must receive dental treatment during the study dates.

13. Presence of an orthodontic appliance that interferes with required clinical assessments.

14. History of allergy to common dentifrice ingredients.

15. Subjects who wear night guard, denture retainers

16. Not willing to abstain from eating crunchy (eg. Granola bars, popcorns, nuts etc) or spicy and hot foods/liquids during the study period;

17. Not willing to abstain from drinking citrus fluids, alcohol, and tea during the study period

18. Non English-speaking subjects

Related Conditions & MeSH terms

• Oral Microbiome
• Wound Heal
• Wounds and Injuries

Intervention

Other:
• cetylpyridinium chloride
The mouthwash is used to see the effects on wound healing and the oral microbiome.

Locations

Country	Name	City	State
United States	Clinical Research Center, College of Dentistry, University of Illinois Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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-1ß, 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.	3 Days