Status:
COMPLETED
Clinical Efficacy of Single-Use of Peroxyl Mouthwash for Reducing Bacteria Saliva and Bioaerosol Contamination Phase 2
Lead Sponsor:
Colgate Palmolive
Conditions:
Healthy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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.
Detailed Description
Following a washout period, subjects will return to the clinical site. A baseline microbial sample will be collected from the operatory's atmosphere for 30 min. prior to the study subject appointment ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04717063
Start Date
November 16 2020
End Date
January 7 2021
Last Update
January 20 2021
Active Locations (1)
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1
Loma Linda University
Loma Linda, California, United States, 92350