Effect of Mouthwashes on Oral Wound Healing and Microbiome

NCT ID: NCT05270382

Last Updated: 2024-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Wound Heal Oral Microbiome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cetylpyridinium chloride/pH adjuster 1

A mouthwash contains cetylpyridinium chloride and pH adjuster 1.

Group Type ACTIVE_COMPARATOR

cetylpyridinium chloride

Intervention Type OTHER

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

Placebo 1

A mouthwash without cetylpyridinium chloride and pH adjuster 1

Group Type PLACEBO_COMPARATOR

cetylpyridinium chloride

Intervention Type OTHER

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

Cetylpyridinium chloride/pH adjuster 2

A mouthwash contains cetylpyridinium chloride and pH adjuster 2.

Group Type ACTIVE_COMPARATOR

cetylpyridinium chloride

Intervention Type OTHER

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

Placebo 2

A mouthwash without cetylpyridinium chloride and pH adjuster 2

Group Type PLACEBO_COMPARATOR

cetylpyridinium chloride

Intervention Type OTHER

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

Interventions

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cetylpyridinium chloride

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Praveen Kumar Gajendrareddy

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Praveen Gajendrareddy, BDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

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

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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CRO-2018-SAL-08-MW-DC

Identifier Type: OTHER

Identifier Source: secondary_id

2018-1417

Identifier Type: -

Identifier Source: org_study_id

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