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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peroxyl | Active Comparator | Drug: Peroxyl Mouthwash Mouthwash Other Names: • 1.5% HP |
|
| placebo mouthwash | Placebo Comparator | Drug: Placebo Mouthwash Mouthwash Other Names: • 0.0% HP Mouthwash |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peroxyl Oral Product | Drug | mouth wash |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the antibacterial efficacy of mouthwash in reducing the levels of bacteria in bioaerosols generated by dental prophylaxis | 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 | 30 min |
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Inclusion Criteria:
Potential subjects must meet ALL of the following criteria:
Exclusion Criteria:
Potential subjects must NOT HAVE ANY of the following conditions:
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| Name | Affiliation | Role |
|---|---|---|
| Yiming Li, DDS MSD PhD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92350 | United States |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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Each subject will be randomized to receive one of the two possible study products
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Triple (Participant, Investigator, Outcome Assessor)
| Placebo | Drug | placebo mouth wash |
|
| D009057 |
| Stomatognathic Diseases |