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

Study Overview
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Brief Summary
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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)

Detailed Description
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Qualified subjects will be enrolled and randomized to either one of the two study groups, balanced on the basis of their initial gingival index scores. Saliva samples will be collected from participants prior to rinsing with their assigned mouthwash (1.5% hydrogen peroxide or 0.0% hydrogen peroxide) for one minute and then expectorate. Saliva samples will again be collected immediately after, at 30 min, and 60 min after rinsing. All collected saliva samples will be placed in sterile vials, labeled with subject information and transferred to the microbiology laboratory for analysis.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Peroxyl Mouthwash
* Drug: Placebo Mouthwash


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each subject will be randomized to receive one of the two possible study products.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peroxyl<br>1.5% Hydrogen Peroxide mouthwash | Drug: Peroxyl Mouthwash<br>* Mouthwash<br>* Other names: 1.5% HP;|
| Placebo Comparator: placebo mouthwash<br>0.0% Hydrogen peroxide mouthwash | Drug: Placebo Mouthwash<br>* Mouthwash<br>* Other names: 0.0% HP Mouthwash;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Colony Forming Unit of total bacteria in saliva and in bioaerosol | Saliva samples will be collected from participants prior to rinsing with their assigned mouthwash (1.5% hydrogen peroxide or 0.0% hydrogen peroxide) for one minute and then expectorate. Saliva samples will again be collected immediately after, at 30 min, and 60 min after rinsing. All collected saliva samples will be placed in sterile vials, labeled with subject information and transferred to the microbiology laboratory for analysis. | baseline, 30 minutes & 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mouthwash, Saliva, Bioaerosol, Bacteria, Gingivitis