Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria in Saliva and Bioaerosol Contamination

Healthy Clinical Trial

Official title:

Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria in Saliva and Bioaerosol Contamination Phase I

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04626778
• Other study ID #: CRO-2020-08-BAC-HP-CA-BGS
• Status: Completed
• Phase: Phase 2
• Start date: October 8, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: November 2020
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the anti-bacterial, pre-procedural, clinical efficacy of Peroxyl mouthwash (1.5% hydrogen peroxide) in saliva and the reduction of bioaerosol contamination as compared to a matching placebo mouthwash (0.0% hydrogen peroxide)

Description:

Qualified subjects will be enrolled and randomized to either one of the two study groups, balanced on the basis of their initial gingival index scores. Saliva samples will be collected from participants prior to rinsing with their assigned mouthwash (1.5% hydrogen peroxide or 0.0% hydrogen peroxide) for one minute and then expectorate. Saliva samples will again be collected immediately after, at 30 min, and 60 min after rinsing. All collected saliva samples will be placed in sterile vials, labeled with subject information and transferred to the microbiology laboratory for analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Potential subjects must meet ALL of the following criteria:

• Subjects, ages 18-70, inclusive.

• Availability for the duration of this clinical research study.

• Good general health.

• At least 20 natural teeth.

• Gingivitis Index 1.0 (Löe-Silness).

• Signed Informed Consent Form

Exclusion Criteria:

• Potential subjects must NOT HAVE ANY of the following conditions:

• Symptoms consistent with COVID-19 or have tested positive.

• Presence of orthodontic bands.

• Tumor(s) of the soft or hard tissues of the oral cavity.

• Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone) or peri-implantitis.

• Five or more carious lesions requiring immediate restorative treatment.

• Use of antibiotic one-month prior to entry into the study.

• Participation in any other clinical study or test panel within the one month prior to entry into the study.

• Dental prophylaxis during the past two weeks prior to baseline examinations.

• History of allergies to oral care/personal care consumer products or their ingredients.

• On any prescription medicines that might interfere with the study outcome.

• An existing medical condition that prohibits not eating or drinking for periods up to 4 hours.

• History of alcohol or drug abuse.

• Self-reported pregnant or lactating subjects.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Peroxyl Mouthwash
Mouthwash
• Placebo Mouthwash
Mouthwash

Locations

Country	Name	City	State
United States	Loma Linda University School of Dentistry, Center for Dental Research	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Colony Forming Unit of total bacteria in saliva and in bioaerosol	Saliva samples will be collected from participants prior to rinsing with their assigned mouthwash (1.5% hydrogen peroxide or 0.0% hydrogen peroxide) for one minute and then expectorate. Saliva samples will again be collected immediately after, at 30 min, and 60 min after rinsing. All collected saliva samples will be placed in sterile vials, labeled with subject information and transferred to the microbiology laboratory for analysis.	baseline, 30 minutes & 60 minutes