Effect of Mouthwashes on Oral Wound Healing and Microbiome

NCT05270382 | Completed

• 2 other identifiers: 2018-1417CRO-2018-SAL-08-MW-DC
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Heal; Oral Microbiome

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Biomarker expression

  3 Days

Study Arms (4)

Cetylpyridinium chloride/pH adjuster 1

ACTIVE COMPARATOR

A mouthwash contains cetylpyridinium chloride and pH adjuster 1.

Other: cetylpyridinium chloride

Placebo 1

PLACEBO COMPARATOR

A mouthwash without cetylpyridinium chloride and pH adjuster 1

Other: cetylpyridinium chloride

Cetylpyridinium chloride/pH adjuster 2

ACTIVE COMPARATOR

A mouthwash contains cetylpyridinium chloride and pH adjuster 2.

Other: cetylpyridinium chloride

Placebo 2

PLACEBO COMPARATOR

A mouthwash without cetylpyridinium chloride and pH adjuster 2

Other: cetylpyridinium chloride

Interventions

cetylpyridinium chloride OTHER

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

Cetylpyridinium chloride/pH adjuster 1; Cetylpyridinium chloride/pH adjuster 2; Placebo 1; Placebo 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

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

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Cetylpyridinium

Intervention Hierarchy (Ancestors)

Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Praveen Gajendrareddy, BDS, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: March 8, 2022
• Study Start: February 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)