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Effect of Mouthwashes on Oral Wound Healing and Microbiome

Primary Purpose

Wound Heal, Oral Microbiome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cetylpyridinium chloride
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Wound Heal

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Research Center, College of Dentistry, University of Illinois ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Cetylpyridinium chloride/pH adjuster 1

Placebo 1

Cetylpyridinium chloride/pH adjuster 2

Placebo 2

Arm Description

A mouthwash contains cetylpyridinium chloride and pH adjuster 1.

A mouthwash without cetylpyridinium chloride and pH adjuster 1

A mouthwash contains cetylpyridinium chloride and pH adjuster 2.

A mouthwash without cetylpyridinium chloride and pH adjuster 2

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 7, 2021
Last Updated
February 25, 2022
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05270382
Brief Title
Effect of Mouthwashes on Oral Wound Healing and Microbiome
Official Title
Clinical Research Study to Evaluate the Effect of Colgate Mouthwashes on Oral Microbiome in Oral Tissue Samples
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal, Oral Microbiome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cetylpyridinium chloride/pH adjuster 1
Arm Type
Active Comparator
Arm Description
A mouthwash contains cetylpyridinium chloride and pH adjuster 1.
Arm Title
Placebo 1
Arm Type
Placebo Comparator
Arm Description
A mouthwash without cetylpyridinium chloride and pH adjuster 1
Arm Title
Cetylpyridinium chloride/pH adjuster 2
Arm Type
Active Comparator
Arm Description
A mouthwash contains cetylpyridinium chloride and pH adjuster 2.
Arm Title
Placebo 2
Arm Type
Placebo Comparator
Arm Description
A mouthwash without cetylpyridinium chloride and pH adjuster 2
Intervention Type
Other
Intervention Name(s)
cetylpyridinium chloride
Intervention Description
The mouthwash is used to see the effects on wound healing and the oral microbiome.
Primary Outcome Measure Information:
Title
Wound healing
Description
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
Title
Microbiome
Description
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
Secondary Outcome Measure Information:
Title
Biomarker expression
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Praveen Gajendrareddy, BDS, PhD
Phone
312-413-8405
Email
praveen@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Praveen Gajendrareddy, BDS, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Center, College of Dentistry, University of Illinois Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Ferguson, MS
Phone
312-996-7226
Email
sfergu2@uic.edu
First Name & Middle Initial & Last Name & Degree
Lin Chen, PhD
Phone
3124135387
Email
chenlin@uic.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Mouthwashes on Oral Wound Healing and Microbiome

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