Healthy
Conditions
Keywords
Mouthwash, Saliva, Bioaerosol, Bacteria, Gingivitis
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 by placing blood agar plates on a support board attached to the bracket chair tray. Upon completion of a half-mouth (e.g. right side) dental prophylaxis, each study subject will be instructed to rinse for one minute with 10 ml of one of the two mouthwash solutions (1.5% hydrogen peroxide or 0.0% hydrogen peroxide) and to expectorate all remaining liquid. Next, the dental prophylaxis will be completed on the other side of the mouth. Bioaerosol samples will be collected prior to and following rinsing on blood agar plates placed on a support board at a 50-degree angle to the participant's chest, on the participant's chest, and on the examiner's forehead. Plates will be closed and labeled. The plates will be transferred to the microbiology laboratory for analysis. All subjects will be followed for adverse events throughout the study.
Interventions
DRUGPeroxyl Oral Product
mouth wash
DRUGPlacebo
placebo mouth wash
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Triple (Participant, Investigator, Outcome Assessor)
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 |
|---|---|---|
| evaluate the antibacterial efficacy of mouthwash in reducing the levels of bacteria in bioaerosols generated by dental prophylaxis | 30 min | baseline microbial sample will be collected from the operatory's atmosphere for 30 min. prior to the study subject appointment by placing blood agar plates on a support board attached to the bracket chair tray. Upon completion of a half-mouth (e.g. right side) dental prophylaxis, each study subject will be instructed to rinse for one minute with 10 ml of one of the two mouthwash solutions (1.5% hydrogen peroxide or 0.0% hydrogen peroxide) and to expectorate all remaining liquid. Next, the dental prophylaxis will be completed on the other side of the mouth. Bioaerosol samples will be collected prior to and following rinsing on blood agar plates placed on a support board at a 50-degree angle to the participant's chest, on the participant's chest, and on the examiner's forehead. Plates will be closed and labeled. The plates will be transferred to the microbiology laboratory for analysis |
Countries
United States
Outcome results
None listed