Overview

Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria Saliva and Bioaerosol Contamination Phase 2

Status:
Completed
Trial end date:
2021-01-07
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the antibacterial efficacy of a commercial mouthwash containing 1.5% hydrogen peroxide in reducing the levels of bacteria in bioaerosols generated by dental prophylaxis.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Colgate Palmolive
Treatments:
Hydrogen Peroxide
Criteria
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.