Overview
Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria Saliva and Bioaerosol Contamination Phase 2
Status:
Completed
Completed
Trial end date:
2021-01-07
2021-01-07
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Colgate PalmoliveTreatments:
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.