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

• Status: Completed
• Trial end date: 2020-12-15
• Target enrollment: 0
• Participant gender: All

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)

• 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.