Effect of Mouthwashes on Oral Wound Healing and Microbiome
NCT ID: NCT05270382
Last Updated: 2024-02-22
Study Results
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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COMPLETED
NA
34 participants
INTERVENTIONAL
2020-02-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Cetylpyridinium chloride/pH adjuster 1
A mouthwash contains cetylpyridinium chloride and pH adjuster 1.
cetylpyridinium chloride
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
cetylpyridinium chloride
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.
cetylpyridinium chloride
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
cetylpyridinium chloride
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
45 Years
ALL
Yes
Sponsors
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University of Illinois at Chicago
OTHER
Responsible Party
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Praveen Kumar Gajendrareddy
Professor
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
Countries
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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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