Effect of Mouthwashes on Oral Wound Healing and Microbiome

University of Illinois

Status: Completed

Conditions: Oral Microbiome; Wound Heal

Treatments: Other: cetylpyridinium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT05270382

CRO-2018-SAL-08-MW-DC (Other Identifier)

2018-1417

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

34 participants in 4 patient groups, including a placebo group

Cetylpyridinium chloride/pH adjuster 1

Active Comparator group

Description:

A mouthwash contains cetylpyridinium chloride and pH adjuster 1.

Treatment:

Other: cetylpyridinium chloride

Placebo 1

Placebo Comparator group

Description:

A mouthwash without cetylpyridinium chloride and pH adjuster 1

Treatment:

Other: cetylpyridinium chloride

Cetylpyridinium chloride/pH adjuster 2

Active Comparator group

Description:

A mouthwash contains cetylpyridinium chloride and pH adjuster 2.

Treatment:

Other: cetylpyridinium chloride

Placebo 2

Placebo Comparator group

Description:

A mouthwash without cetylpyridinium chloride and pH adjuster 2

Treatment:

Other: cetylpyridinium chloride