Healthy
Conditions
Keywords
Mouthwash, Saliva, Bioaerosol, Bacteria, Gingivitis
Brief 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)
Detailed 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.
Interventions
DRUGPeroxyl Mouthwash
Mouthwash
DRUGPlacebo Mouthwash
Mouthwash
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
A blinded randomized controlled parallel group design trial
Intervention model description
Each subject will be randomized to receive one of the two possible study products.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Colony Forming Unit of total bacteria in saliva and in bioaerosol | baseline, 30 minutes & 60 minutes | 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. |
Countries
United States
Outcome results
None listed